Monday, August 10, 2009
Site Management in Clinical Research Covered in New Online Journal Posting
Please click here to read an interesting new article just published in The Clinical Researcher on the importance of site management in clinical research when conducting clinical trials in India. The article, appropriately titled "Site Management In Clinical Trials" and written by Mr. Srinivas Pai Raikar, Assistant Director of Operations for Chicago, IL and Noida (New Delhi) based Excel Life Sciences, discusses the different elements of clinical research at investigative sites in India and how a Site Management Organization can positively impact performance.
New Article Shows Different Sides of Business and Clinical Research in India
A new article published in Applied Clinical Trials Magazine addresses and challenges some of the most common myths related to the conduct of business and clinical research in India. The article, titled "Demystifying India -Understanding common myths and truths surrounding one of the fastest growing clinical trial markets" provides readers with a unique perspective on the unique realities of daily life in India which impact clinical research in different ways. Topics/myths covered include a discussion on the the stability of the market, the complexity and timeliness of the regulatory environment, the structure and operating process of IRBs, the informed consent process and the enrollment of patients in India. Below is a small excerpt from the article. Please click on the link to proceed to the Applied Clinical Trials Online website to read the full article:
Excerpt from "Demystifying India -Understanding common myths and truths surrounding one of the fastest growing clinical trial markets" published July 31, 2009, author: Dan McDonald - VP, Business Strategy, Excel Life Sciences:
"But India can be as confusing and slow as much as it seems simple and efficient. It can be scary and overwhelming as much as it is warm and traditional. India can mean faster, lower-cost clinical trials, but it can also mean 85 people sitting in the waiting room of a small eye clinic at 9:00pm hoping to get a visit with a doctor before he leaves at 10:00pm after putting in a 14 hour day. Most will have to go home and try again tomorrow—even though home may be two hours away."
Click here to read the full article.
Friday, July 3, 2009
Extensive Article on Growth of the Indian Clinical Research Market Features Views from ELS Executive
ClinPage.com
June 5, 2009
ELS VP of Business Strategy, Dan McDonald was recently interviewed by US-based e-publisher ClinPage.com regarding the rapid growth of the Indian market, including challenges and success stories. The article, titled India is Hot, includes interviews with industry executives and other stakeholders, including insights from McDonald regarding the patient and cultural considerations that need to be taken into account when running studies in India.
Please click here to view the article.
June 5, 2009
ELS VP of Business Strategy, Dan McDonald was recently interviewed by US-based e-publisher ClinPage.com regarding the rapid growth of the Indian market, including challenges and success stories. The article, titled India is Hot, includes interviews with industry executives and other stakeholders, including insights from McDonald regarding the patient and cultural considerations that need to be taken into account when running studies in India.
Please click here to view the article.
Story on the Growth in Size and Quality of the Investigative Site Network in India Features ELS Executive
ClinPage.com
June 12, 2009
Story on the Growth in Size and Quality of the Investigative Site Network in India Features ELS Executive Insights on the Business Aspect of Site – Sponsor Relationships
ELS VP of Business Strategy, Dan McDonald was recently interviewed by US-based e-publisher ClinPage.com regarding the dynamics of the investigative site market in India vs. the investigative site markets in more mature markets. The article, titled India: Investigator Snapshot, includes interviews with industry executives and other stakeholders, including insights from McDonald regarding the size and capacity of the site market.
Please click the link below:
http://www.clinpage.com/article/india_investigator_snapshot/C15
June 12, 2009
Story on the Growth in Size and Quality of the Investigative Site Network in India Features ELS Executive Insights on the Business Aspect of Site – Sponsor Relationships
ELS VP of Business Strategy, Dan McDonald was recently interviewed by US-based e-publisher ClinPage.com regarding the dynamics of the investigative site market in India vs. the investigative site markets in more mature markets. The article, titled India: Investigator Snapshot, includes interviews with industry executives and other stakeholders, including insights from McDonald regarding the size and capacity of the site market.
Please click the link below:
http://www.clinpage.com/article/india_investigator_snapshot/C15
Thursday, June 18, 2009
PFC Pharma Focus and Excel Life Sciences Announce Clinical Research Partnership in India
European CRO and US-based Trial Management Organization Announce Unique Partnership to Ensure Highest Quality of Clinical Trials in India. New Venture to Provide Sponsors Access to Global Experience, Diverse Patient Population, Highly Trained Investigators and Local Expertise.
Zürich/Chicago (PRWEB) 18, June, 2009 – In response to growing demand by European and US biopharmaceutical companies for clinical trial support services in India from established and proven providers, Excel Life Sciences (ELS), a US-based India-focused clinical trial management organization and PFC Pharma Focus (PFC), a Switzerland-based pan-European contract research provider, announce the launch of PFC India, a full-service contract research organization specializing in clinical monitoring and data management services.
The exclusive relationship between ELS and PFC to launch PFC India combines the strengths of a long standing and successful European CRO with the local expertise, ground-based business savvy and quality focused trial management of ELS.
PFC India is established as a division of PFC and is a distinct entity from ELS and will service biopharmaceutical companies and CROs with their clinical trial support needs in India. The office will be located in New Delhi. Specifically, PFC India will offer its clients study planning, monitoring, audit and data management services.
“I am very pleased that we can extend our clinical research services with PFC India from Europe to Israel to India and to offer our clients access to a large diverse patient population as well as to a significant number of patients suffering from rare diseases" said Dr. Kurt Pfister, CEO and co-founder of PFC Pharma Focus Ltd. in Switzerland. India offers the unique opportunity of highly trained medically qualified persons and a legal and regulatory environment fully supporting international GCP standards. ELS is well established in India and the team has market leading experience in conducting global trials. They have a proven track record in involving high performing centers with very good patient recruitment and retention rates and will enable us to make a smooth entry into this geographical area. “Selection of ELS as a partner was a result of rigorous due diligence and a shared vision to conduct clinical research with the highest levels of credibility, ethics and integrity” said Dr. Pfister.
“We are excited about this new relationship, brining one of the most respected European-based CROs to India. PFC India will bring an unprecedented focus on quality data and good clinical practice to India, at a time when the FDA and Drugs Controller General’s office of India is stepping up it’s compliance standards and pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand” said Dr. Vijai Kumar, President and Chief Medical Officer of Excel Life Sciences.
The number of new clinical trials initiated in India is currently growing at more than 50% annually, a growth rate that is requiring a substantial amount of participation from India’s strong physician base and medical institutions in the form of new clinical investigators and research sites. In addition, the number of patients participating in trials in India is growing as well. Combined, these market changes make it essential that all studies are monitored and managed at or above the highest international standards to ensure quality, timeliness and safety.
About Pharma Focus
Based in Switzerland, PFC Pharma Focus is a premium contract research organization (CRO), providing product development services in the life science and health care industries. Founded in 1992 by prominent experts in all realms of clinical services, the mission of PFC Pharma Focus is to bring a new look to the drug development experience by addressing the limitations of conventional study practices. This year marks PFC 17 anniversary providing clinical services, and our clients and partners include pharmaceutical, biotechnology, medical device, and academic and government organizations. PFC services include running clinical studies from phase I to IV+, medical writing, importing through storage to distribution of clinical material, training in pharmaceutical medicine and development of risk management plans. For more information visit: http://www.pfc-cro.com/pages/index.cfm
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.excellifesciences.com
Contact:
Excel Life Sciences
Chicago, IL
Phone: 773 251 2976
Contact: Kurt Pfister
PFC Pharma Focus Ltd.
Zürich, Switzerland
Phone : +41 44 908 66 66
Tuesday, February 3, 2009
First Survey Made Public on the Understanding and Experiences of Clinical Research Volunteers in India
It is well known that India is a region of the world where clinical research is on the rise. There are many incentives for conducting research in India, including its huge population of treatment-naïve patients and lower cost of conducting trials. It’s estimated that by 2010, the clinical research market in India will reach $500-600 million (1) .
That growth has also brought a tremendous amount of regulatory oversight and safety measures to protect the rights of patients. But that growth has also attracted a tremendous amount of scrutiny and negative media coverage. However, not much information has been publicized regarding Indian patient’s knowledge and understanding of clinical research and their experiences, especially with the Informed Consent process.
Excel Life Sciences has recently conducted a survey of over 500 study participants. This Excel Life Sciences research brief analyzes the important findings of that study and includes comparisons to a study of U.S. patients conducted by CenterWatch.
Key Findings:
Observations and Conclusions:
Better than Expected Understanding
Considering that India is still an nascent market for clinical research, Excel Life Sciences was surprised to find that over 40% of patients had some understanding about clinical research trials prior to participating. Most patients though, lacked more than surface level awareness and understanding. Overall, patients seemed to have a strong understanding of what was required of them in a study and the risks of participating. In general, the vast majority of patients, some 97%, understood the informed consent document (70% very well, 27% somewhat well). Specifically, patients had a strong understanding of the following:
The advent and expansion of the Internet, along with the litigious healthcare environment in the United States has caused many patients to pursue a variety of information sources to make educated healthcare decisions. In fact, U.S. surveys have found that more than 60% of volunteers go outside of their managed-care setting to self-refer into clinical trials. The Excel Life Sciences survey has found that there is a much more traditional information system in place in India, where patients still turn to their physicians for information about their health. In total 97% of patients in the Excel Life Sciences survey, first learned about the study through a physician, including primary care (76%) or another physician (21%).
Patients: Decision Support System is Strong
According to survey findings, there is both a cultural and operational support system in place in India assisting patients with making an informed decision:
Authors:
Dr. Vijai Kumar, President and Chief Medical Officer - Excel Life Sciences,
Dr. Saurendra Das, Executive Director of Operations, India – Excel Life Sciences
Dan McDonald, Vice President-Business Strategy - Excel Life Sciences.
The study was last updated October 2008.
(1) Pricewaterhouse Coopers September 2008 Forecasting Report
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.excellifesciences.com
That growth has also brought a tremendous amount of regulatory oversight and safety measures to protect the rights of patients. But that growth has also attracted a tremendous amount of scrutiny and negative media coverage. However, not much information has been publicized regarding Indian patient’s knowledge and understanding of clinical research and their experiences, especially with the Informed Consent process.
Excel Life Sciences has recently conducted a survey of over 500 study participants. This Excel Life Sciences research brief analyzes the important findings of that study and includes comparisons to a study of U.S. patients conducted by CenterWatch.
Key Findings:
- 56% of patients in India were not aware of clinical research prior to participating in a study
- 97% of patients understood the informed consent form (70% very well, 27% well)
- 97% of patients first found out about the clinical study through a physician, vs just 23% in the United States
- Only 8% of patients in India made the decision to participate on their own, vs 38% in the United States
Observations and Conclusions:
Better than Expected Understanding
Considering that India is still an nascent market for clinical research, Excel Life Sciences was surprised to find that over 40% of patients had some understanding about clinical research trials prior to participating. Most patients though, lacked more than surface level awareness and understanding. Overall, patients seemed to have a strong understanding of what was required of them in a study and the risks of participating. In general, the vast majority of patients, some 97%, understood the informed consent document (70% very well, 27% somewhat well). Specifically, patients had a strong understanding of the following:
- 98% understood the number of times that they would have to visit the study site
- 93% understood that the study would carry risks and discomforts
The advent and expansion of the Internet, along with the litigious healthcare environment in the United States has caused many patients to pursue a variety of information sources to make educated healthcare decisions. In fact, U.S. surveys have found that more than 60% of volunteers go outside of their managed-care setting to self-refer into clinical trials. The Excel Life Sciences survey has found that there is a much more traditional information system in place in India, where patients still turn to their physicians for information about their health. In total 97% of patients in the Excel Life Sciences survey, first learned about the study through a physician, including primary care (76%) or another physician (21%).
Patients: Decision Support System is Strong
According to survey findings, there is both a cultural and operational support system in place in India assisting patients with making an informed decision:
- Culturally, the role of the family and trust in their primary care physician play a very important part in a patient’s decision to participate. Most patients travel with loved ones to doctor visits and the same is true for their clinical trial visits. Only 8% of volunteers made the decision to participate in the trial by themselves vs. 38% in the United States.
- Operationally, the sites involved in the survey had a dedicated highly trained clinical research coordinator working at the study site, assisting busy physicians with running the trial and helping to answer questions patients or their loved ones have about the study and informed consent form.
Authors:
Dr. Vijai Kumar, President and Chief Medical Officer - Excel Life Sciences,
Dr. Saurendra Das, Executive Director of Operations, India – Excel Life Sciences
Dan McDonald, Vice President-Business Strategy - Excel Life Sciences.
The study was last updated October 2008.
(1) Pricewaterhouse Coopers September 2008 Forecasting Report
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.excellifesciences.com
Competitive Technologies Announces Sales Order From ELS for Pain Management Devices
Fairfield, CT - (January 12, 2009) - Competitive Technologies, Inc. (NYSE Alternext US: CTT) announced today that it has received a sales order from Excel Life Sciences, Inc. (ELS) for pain management therapy devices. The device is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. ELS, CTT's country-exclusive distributor in India, recognizing the benefits of the innovative device, was the first announced healthcare services provider to sign a distribution agreement for the device. Subsequent distribution agreements granted country-exclusive distribution rights to GEOMC Co., Ltd. for Korea, to AG Healthcare for Malaysia, and to Biogene Pharma Limited for Bangladesh.
The order from ELS has an approximate retail value of up to $1 million. Shipment of the devices to ELS is scheduled to begin immediately.
ELS is a U.S.-based, India-focused provider of clinical research and healthcare services. They have a special focus on improving patient care in the markets in which they operate. ELS has a fully-owned Indian subsidiary with its main office in New Delhi, and 21 operational locations serving a network of over 700 hospitals across India.
The CTT device has Medical Device CE certification from the European Union allowing sales of the device throughout Europe and several other countries, including India. Approval of CTT's pending FDA 510(k) medical device application will authorize U.S. sales of the device. The review and selection process for distributors in Europe, Asia, the U.S. and Latin America is continuing. CTT has exclusive worldwide rights to this patented device.
Dr. Vijai Kumar, ELS's President and Chief Medical Officer, said, "We have seen this device in action, and have witnessed its pain relieving capabilities. ELS is starting formal clinical studies using this new pain management device at four leading healthcare facilities in India within the month. The protocol for these studies will follow U.S. FDA guidelines and treat a total of 160 patients divided into four specific neuropathies. We expect this new device to initiate a paradigm shift in the perception and treatment of pain in India. There are over four million people in the country suffering from severe cancer, neuropathic pain and other forms of chronic disabling pain."
Mohit Mehrotra, ELS's Founder and Chief Operating Officer, commented, "We are proud to work with CTT to bring this progressive medical technology to India. We are focusing considerable resources on this technology and our relationship with CTT. We will be launching the device at the All India Institute of Medical Sciences' (AIIMS) International Conference of Indian Association of Palliative Care in February, where we expect it to generate a high level of activity and interest among the participants. ELS is a sponsor of the New Delhi-based conference, the largest of its type. Our extensive knowledge about healthcare in India, along with a large network of research hospitals and clinics, helps us understand the needs and expectations of both patients and healthcare providers. We believe this device will revolutionize pain management for both constituents."
"ELS is a key element in our strategy for building a strong distribution base across the Indian continent through Southeast Asia," said Aris D. Despo, CTT's Executive VP, Business Development. "They are an effective and strategic partner for CTT in the important Indian market. India's $1.75 billion medical device market, supported by its growing middle and upper classes of over 150 million people, represents a significant opportunity for sales of our innovative pain management technology."
"We believe that revenue and profits from the pain management technology will dramatically exceed those produced by any other technology in our 40-year history and reach approximately $200 million per year in distributor sales to hospitals and clinics as the device attains mature market levels," said John B. Nano, CTT's Chairman, President and CEO. "We expect financial results generated by this medical device to have the potential to significantly increase CTT market capitalization. This medical device is a prime example of our strategy to connect clinical science to patient care, improving healthcare for mankind."
Developed in Italy by CTT's client, Prof. Giuseppe Marineo, the technology was brought to CTT through the efforts of Prof. Giancarlo Elia Valori of the Italian business development group, Sviluppo Lazio S.p.A., and assistance from the Zangani Investor Community™. The technology, with a biophysical rather than a biochemical approach, uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin. CTT partner, GEOMC Co., Ltd. of Korea, is manufacturing the device commercially for worldwide distribution. For more information on the device, visit www.CalmareTT.com.
The device has been used on over 3,000 patients in Europe, including at the Pain Management Center at Tor-Vergata University Medical Center in Rome (http://www.ptvonline.it/uo_ter_ant_ing.asp)., and at Fondazione Parco Biomedico San Raffaele in Rome (www.scienceparkrome.eu).
About Excel Life Sciences, Inc.
ELS is a U.S.-based, India-focused provider of comprehensive clinical research and healthcare services, helping to advance science and improve patient care. ELS is a privately owned Delaware corporation, with 21 operational locations across India and a network of approximately 1,000 physicians serving over 700 hospitals. ELS has U.S. offices in Boston, Chicago, and Durham, N.C. Its success is built around passionate and experienced individuals working alongside clients to accelerate clinical research and deliver new drugs and medical devices to the markets, while maintaining the highest standards of quality. ELS is committed to improving and expanding the clinical research enterprise in India. Visit ELS's website: www.ExcelLifeSciences.com
About Competitive Technologies
Competitive Technologies, established in 1968, is a full service technology transfer and licensing provider focused on the technology needs of its customers and transforming those requirements into commercially viable solutions. CTT is a global leader in identifying, developing and commercializing innovative technologies in life, electronic, nano, and physical sciences developed by universities, companies and inventors. CTT maximizes the value of intellectual assets for the benefit of its customers, clients and shareholders. Visit CTT's website: www.competitivetech.net
Statements made about our future expectations are forward-looking statements and subject to risks and uncertainties as described in our most recent Annual Report on Form 10-K for the year ended July 31, 2008, filed with the SEC on October 28, 2008, and other filings with the SEC, and are subject to change at any time. Our actual results could differ materially from these forward-looking statements. We undertake no obligation to update publicly any forward-looking statement.
Wednesday, January 14, 2009
Clinical Research India Primer
Up until 2005, India was probably best known in the world of pharmaceuticals as a generic powerhouse. Due to poor laws around intellectual property, most multi-national biopharmaceutical companies did not seriously consider India as a destination for clinical trials. Numerous other challenges and roadblocks existed as well. But as the Industry began to globalize rapidly throughout the 90’s and early part of this decade, regulators, entrepreneurs and businesses began to recognize the significant economic opportunity that they were facing, as well as the opportunity to gain new credibility in the world of medicine, science and the international business community. The response was a profound and rapid change in the regulatory landscape related to research and intellectual property that has created an inviting market which is realizing true and sustained growth.
So what is the regulatory environment today and where does it need to go?
The regulatory environment has improved dramatically in a short time period, with development of a standardized and predictable regulatory review and approval process. There are a growing number of FDA compliant IRBs. To some degree the process can be even better than other parts of the world in that conditional IRB approval can precede Ministry of Health approval. Regulatory approval timelines are also very reasonable and because sites are largely new to clinical research or don’t have established business practices related to clinical research, PI and site contracts can take as little as 3-5 weeks. A Regulatory Affairs CRO India can assist global biopharmaceutical companies with effectively planning and placing their clinical trials in India.
A look at 1572 filings – the form an investigator needs to submit in order to participate in a US IND study – shows that a rapidly growing number of investigators are from India, far outnumber growth rates seen in other Asia-pacific regions such as China, Japan and Australia. Sponsors are finding that the regulatory timelines, data quality, costs and abundance of patients make India one of the most attractive countries in the Eastern world to run their studies.
The attractive aspects of the market are translating to a growth spurt in the number of studies taking place in India. An analysis conducted by Excel Life Sciences has identified a minimum of nearly 900 clinical trials taking place in India today, a number that is growing by double digits annually. This figure doesn’t take into account non US IND studies, investigator initiated studies and other studies taking place.
The well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of categories, including perhaps most importantly to many companies, the regulatory environment and timelines.
Epidemiology
Like many diseases in India, given the size of the patient population and lack of standardized healthcare, disease prevalence is often much higher than other regions of the world and many of the patients are treatment naïve. These factors typically result in shortened enrollment timelines and naturally reduced costs.
If you look at the breakout, it reflects those therapeutic areas made up of conditions that are most prevalent in India. These conditions to some degree represent the evolving and improving socioeconomic status of India – essentially lifestyle diseases, e.g. Cardiovascular conditions, Diabetes and other endocrinology conditions, as well as many types of cancer. For example:
Oncology/Cancer
Today there are an estimated 2.5M people in India suffering from cancer and that number is expected to grow significantly in the months and years ahead driven by strong growth in tobacco related cancers, as well as those that are environmentally driven as India continues to develop rapidly from an economic and lifestyle perspective. An Oncology CRO India can assist sponsors with finding and screening these patients for their clinical trials.
Cardiovascular Diseases
The overall incidence of heart disease has doubled in India during the last 20 years and this trend is expected to continue. The World Health Organization (WHO) estimates that 60% of the world's cardiac patients will be Indian by 2010. Our statistics show that between the years 2003 and 2006, top sites in India saw over 100,000 patients. A Cardiology CRO India may be used by a global biopharmaceutical company to identify and enroll these patients in a clinical trial.
Endocrine and Metabolic Disorders
An estimated 108 million people in India suffer from endocrine and metabolic disorders. Diabetes is the most prevalent disease in this therapeutic area with approximately 35.5 million cases. Our clinical investigators have experience conducting global trials and have access to a large and diverse treatment naive patient pool. In fact, these investigators see 400 - 500 new cases per month and provide treatment for approximately 2,000 ongoing cases per month. An Endocrinology CRO India and Diabetes CRO India like Excel Life Sciences can assist global biopharmaceutical companies with identifying and enrolling the right patients for their clinical trials.
Neurology
India has a high prevalence for neurological and psychiatric diseases and disorders. Our statistics show that between the years 2003 to 2006 some of the leading sites in India saw over 30,000 psychiatry and over 40,000 neurology patients respectively. Although many people are already being treated, the majority are not. The World Health Organization (WHO) estimates that at minimum, an additional 25 million people in India are in need of mental health services. A Neurology CRO India or Neuropsychiatry CRO India like Excel Life Sciences can assist global biotech and pharmaceutical companies with identifying the right Neurology patients for their clinical trials.
Contract Research Organization India / CRO India Support:
There are several different models and configurations that exist today in terms of who sponsors might partner with to place and conduct studies in India. The least common way is through Sponsors identifying and hiring their own sites. You really don’t see much of this and sites haven’t built up the confidence and business know-how to be soliciting business with Sponsors on their own.
Instead there are 2-3 common models that exist. What makes Model #1 interesting from a US perspective is that it involves the use of a Trial or Site Management Organization – terms and concepts that have a slightly negative connotation in the US and Western Europe as a promise largely gone unfulfilled. In the US the SMO concept peaked during the 1990’s and early part of this decade, but many of the SMOs found that sites didn’t need or appreciate the support and that sponsors weren’t willing to award them more than a handful of sites in many cases. In India though, the concept is thriving. Largely due to the vast network of inexperienced sites, who:
1. Don’t have the know-how or means to market and contract their own business – so the SMO acts as the lead generator.
2. Need the support of a full-time CRC from the SMO for day-to-day study conduct, which due to large patient loads, the investigator does not have the time to manage.
So, this model is being used more often, where Sponsors looking to place a study in India work with an TMO/SMO to handle all aspects of regulatory, site selection, patient enrollment and so on and then the SMO contracts with a CRO to handle the monitoring aspect of the study, therefore avoiding a conflict of interest. This is why these companies are now being referred to as Trial Management Organizations, because they handle most of the activities that traditional SMOs and CROs handle without conducting the monitoring.
Sponsors are finding that day-to-day site management is critical in India since there are often first time investigators involved in a study and more importantly, the patient loads and activity level at each site, warrant the placement of and support from a full-time CRC. In general, sponsors are finding that patients are enrolled faster, retained better and that there is higher quality data coming from the site when a SMO is involved. In profiling more than 900 sites across India, Excel Life Sciences found that less than 15% of all sites have a full-time CRC on staff. When a CRC is present, they are typically spread across multiple studies.
The Trial Management Organization in India is a hub of activity for a clinical study. This multi-faceted approach requires superior upfront and ongoing training as well as vigilant project management and site support.
A comprehensive site support model involves placement of a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-today study conduct activities. Coordinators must be trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site. CRC study conduct support activities can include, but are not limited to the following:
Prestudy:
• Regulatory Submissions
• Select PI
• PI Training Programs
• Patient data base
• IRB submission
• Pre screening
• Source Document (SD) templates
• Referrals
Study conduct:
• Identify patients, SIV
• Assist ICD
• Ensure SD
• Transcribe CRF
• Send lab samples
• Scrutinize results
• Maintain Trial Master File
• Prepare for monitoring & audit
• Track enrollment
• Ensure 100% follow up
• Timely payment of patient expenses
Post study:
• Query resolution
• Study close out
So what is the regulatory environment today and where does it need to go?
The regulatory environment has improved dramatically in a short time period, with development of a standardized and predictable regulatory review and approval process. There are a growing number of FDA compliant IRBs. To some degree the process can be even better than other parts of the world in that conditional IRB approval can precede Ministry of Health approval. Regulatory approval timelines are also very reasonable and because sites are largely new to clinical research or don’t have established business practices related to clinical research, PI and site contracts can take as little as 3-5 weeks. A Regulatory Affairs CRO India can assist global biopharmaceutical companies with effectively planning and placing their clinical trials in India.
A look at 1572 filings – the form an investigator needs to submit in order to participate in a US IND study – shows that a rapidly growing number of investigators are from India, far outnumber growth rates seen in other Asia-pacific regions such as China, Japan and Australia. Sponsors are finding that the regulatory timelines, data quality, costs and abundance of patients make India one of the most attractive countries in the Eastern world to run their studies.
The attractive aspects of the market are translating to a growth spurt in the number of studies taking place in India. An analysis conducted by Excel Life Sciences has identified a minimum of nearly 900 clinical trials taking place in India today, a number that is growing by double digits annually. This figure doesn’t take into account non US IND studies, investigator initiated studies and other studies taking place.
The well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of categories, including perhaps most importantly to many companies, the regulatory environment and timelines.
Epidemiology
Like many diseases in India, given the size of the patient population and lack of standardized healthcare, disease prevalence is often much higher than other regions of the world and many of the patients are treatment naïve. These factors typically result in shortened enrollment timelines and naturally reduced costs.
If you look at the breakout, it reflects those therapeutic areas made up of conditions that are most prevalent in India. These conditions to some degree represent the evolving and improving socioeconomic status of India – essentially lifestyle diseases, e.g. Cardiovascular conditions, Diabetes and other endocrinology conditions, as well as many types of cancer. For example:
Oncology/Cancer
Today there are an estimated 2.5M people in India suffering from cancer and that number is expected to grow significantly in the months and years ahead driven by strong growth in tobacco related cancers, as well as those that are environmentally driven as India continues to develop rapidly from an economic and lifestyle perspective. An Oncology CRO India can assist sponsors with finding and screening these patients for their clinical trials.
Cardiovascular Diseases
The overall incidence of heart disease has doubled in India during the last 20 years and this trend is expected to continue. The World Health Organization (WHO) estimates that 60% of the world's cardiac patients will be Indian by 2010. Our statistics show that between the years 2003 and 2006, top sites in India saw over 100,000 patients. A Cardiology CRO India may be used by a global biopharmaceutical company to identify and enroll these patients in a clinical trial.
Endocrine and Metabolic Disorders
An estimated 108 million people in India suffer from endocrine and metabolic disorders. Diabetes is the most prevalent disease in this therapeutic area with approximately 35.5 million cases. Our clinical investigators have experience conducting global trials and have access to a large and diverse treatment naive patient pool. In fact, these investigators see 400 - 500 new cases per month and provide treatment for approximately 2,000 ongoing cases per month. An Endocrinology CRO India and Diabetes CRO India like Excel Life Sciences can assist global biopharmaceutical companies with identifying and enrolling the right patients for their clinical trials.
Neurology
India has a high prevalence for neurological and psychiatric diseases and disorders. Our statistics show that between the years 2003 to 2006 some of the leading sites in India saw over 30,000 psychiatry and over 40,000 neurology patients respectively. Although many people are already being treated, the majority are not. The World Health Organization (WHO) estimates that at minimum, an additional 25 million people in India are in need of mental health services. A Neurology CRO India or Neuropsychiatry CRO India like Excel Life Sciences can assist global biotech and pharmaceutical companies with identifying the right Neurology patients for their clinical trials.
Contract Research Organization India / CRO India Support:
There are several different models and configurations that exist today in terms of who sponsors might partner with to place and conduct studies in India. The least common way is through Sponsors identifying and hiring their own sites. You really don’t see much of this and sites haven’t built up the confidence and business know-how to be soliciting business with Sponsors on their own.
Instead there are 2-3 common models that exist. What makes Model #1 interesting from a US perspective is that it involves the use of a Trial or Site Management Organization – terms and concepts that have a slightly negative connotation in the US and Western Europe as a promise largely gone unfulfilled. In the US the SMO concept peaked during the 1990’s and early part of this decade, but many of the SMOs found that sites didn’t need or appreciate the support and that sponsors weren’t willing to award them more than a handful of sites in many cases. In India though, the concept is thriving. Largely due to the vast network of inexperienced sites, who:
1. Don’t have the know-how or means to market and contract their own business – so the SMO acts as the lead generator.
2. Need the support of a full-time CRC from the SMO for day-to-day study conduct, which due to large patient loads, the investigator does not have the time to manage.
So, this model is being used more often, where Sponsors looking to place a study in India work with an TMO/SMO to handle all aspects of regulatory, site selection, patient enrollment and so on and then the SMO contracts with a CRO to handle the monitoring aspect of the study, therefore avoiding a conflict of interest. This is why these companies are now being referred to as Trial Management Organizations, because they handle most of the activities that traditional SMOs and CROs handle without conducting the monitoring.
Sponsors are finding that day-to-day site management is critical in India since there are often first time investigators involved in a study and more importantly, the patient loads and activity level at each site, warrant the placement of and support from a full-time CRC. In general, sponsors are finding that patients are enrolled faster, retained better and that there is higher quality data coming from the site when a SMO is involved. In profiling more than 900 sites across India, Excel Life Sciences found that less than 15% of all sites have a full-time CRC on staff. When a CRC is present, they are typically spread across multiple studies.
The Trial Management Organization in India is a hub of activity for a clinical study. This multi-faceted approach requires superior upfront and ongoing training as well as vigilant project management and site support.
A comprehensive site support model involves placement of a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-today study conduct activities. Coordinators must be trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site. CRC study conduct support activities can include, but are not limited to the following:
Prestudy:
• Regulatory Submissions
• Select PI
• PI Training Programs
• Patient data base
• IRB submission
• Pre screening
• Source Document (SD) templates
• Referrals
Study conduct:
• Identify patients, SIV
• Assist ICD
• Ensure SD
• Transcribe CRF
• Send lab samples
• Scrutinize results
• Maintain Trial Master File
• Prepare for monitoring & audit
• Track enrollment
• Ensure 100% follow up
• Timely payment of patient expenses
Post study:
• Query resolution
• Study close out
Friday, January 9, 2009
Excel Life Sciences and Investigator Support Services Announce Clinical Research Partnership
Dec. 18, 2008, Chicago, IL - Excel Life Sciences (ELS), a U.S.-based, India-focused provider of comprehensive trial management services announces that it has formed a partnership with Chicago-based Investigator Support Services (ISS) to help biopharmaceutcal companies and CROs identify investigative sites in India for their clinical research studies.
ELS has one of the largest networks of investigative sites in India with over 1,000 investigators and 700 sites. Each site has undergone an extensive due diligence visit and review by ELS to determine its experience and capabilities before they are accepted into the ELS network, enabling ELS to find the most qualified investigative sites for customers. In three recent studies, sponsors selected 100%, 80% and 100% of sites recommended by ELS for the study.
“We are very excited to be partnering with ISS to help their customers identify appropriate investigative sites in India. We are confident that together we can help more companies enter into India and run successful, on-time clinical studies,” said Dr. Vijai Kumar, President and Chief Medical Officer, Excel Life Sciences.
ISS represents 400 experienced sites with capabilities to conduct phase I-IV drug and device studies in all medical specialties.. All sites pass a quality review prior to inclusion in the ISS network and are further pre-qualified for individual studies based on protocol requirements. At no cost to industry sponsors and CROs, ISS quickly provides study related documents and contact information for the most appropriate investigators. Sponsors and CROs negotiate budgets and contracts with site personnel, make the final selection decision, and remit payment directly to participating sites.
“For 16 years, ISS has supported drug development in by matching clinical trials with qualified investigators. Each year we successfully place sites on nearly 250 studies for more than 80 sponsors and CROs in the United States, and we are excited to expand our reach to India in support of global clinical research,” said Sarah Ebner, President, Investigator Support Services.
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.ExcelLifeSciences.com.
About Investigator Support Services
Investigator Support Services (ISS) supports industry sponsors and CROs, worldwide, by expediting site identification for phase I-IV studies across all therapeutic areas. At no cost to either the sponsor or CRO, ISS provides access to hundreds of experienced research sites, pre-qualified for US and global trials based on protocol requirements. Investigators join ISS at no charge and benefit from a continuous stream of new trials matched with their interests and capabilities. Sites remain independent and contract on a study-by-study basis, paying a percentage-based fee only upon selection and payment from the sponsor.
ISS also represents a healthcare call center specializing in patient recruitment and related clinical trial services. Multilingual nurse and lay operators, Interactive Voice Response System (IVRS), and Web-based screening tools pre-qualify callers according to study inclusion/exclusion criteria. Call center solutions include a full range of patient retention and compliance programs, fulfillment services, and custom-tailored data management and reporting options. For more information visit www.ResearchSite.net.
ELS has one of the largest networks of investigative sites in India with over 1,000 investigators and 700 sites. Each site has undergone an extensive due diligence visit and review by ELS to determine its experience and capabilities before they are accepted into the ELS network, enabling ELS to find the most qualified investigative sites for customers. In three recent studies, sponsors selected 100%, 80% and 100% of sites recommended by ELS for the study.
“We are very excited to be partnering with ISS to help their customers identify appropriate investigative sites in India. We are confident that together we can help more companies enter into India and run successful, on-time clinical studies,” said Dr. Vijai Kumar, President and Chief Medical Officer, Excel Life Sciences.
ISS represents 400 experienced sites with capabilities to conduct phase I-IV drug and device studies in all medical specialties.. All sites pass a quality review prior to inclusion in the ISS network and are further pre-qualified for individual studies based on protocol requirements. At no cost to industry sponsors and CROs, ISS quickly provides study related documents and contact information for the most appropriate investigators. Sponsors and CROs negotiate budgets and contracts with site personnel, make the final selection decision, and remit payment directly to participating sites.
“For 16 years, ISS has supported drug development in by matching clinical trials with qualified investigators. Each year we successfully place sites on nearly 250 studies for more than 80 sponsors and CROs in the United States, and we are excited to expand our reach to India in support of global clinical research,” said Sarah Ebner, President, Investigator Support Services.
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.ExcelLifeSciences.com.
About Investigator Support Services
Investigator Support Services (ISS) supports industry sponsors and CROs, worldwide, by expediting site identification for phase I-IV studies across all therapeutic areas. At no cost to either the sponsor or CRO, ISS provides access to hundreds of experienced research sites, pre-qualified for US and global trials based on protocol requirements. Investigators join ISS at no charge and benefit from a continuous stream of new trials matched with their interests and capabilities. Sites remain independent and contract on a study-by-study basis, paying a percentage-based fee only upon selection and payment from the sponsor.
ISS also represents a healthcare call center specializing in patient recruitment and related clinical trial services. Multilingual nurse and lay operators, Interactive Voice Response System (IVRS), and Web-based screening tools pre-qualify callers according to study inclusion/exclusion criteria. Call center solutions include a full range of patient retention and compliance programs, fulfillment services, and custom-tailored data management and reporting options. For more information visit www.ResearchSite.net.
Thursday, January 8, 2009
India: Attractive Market for Biopharmaceutical Companies Looking to Accelerate Clinical Trials
The Clinical Research Market in India is growing at a very rapid rate according to anyone’s statistics…It is exploding according to all the hype.
For a long time, India has been a hotbed for companies in several major industries looking to outsource and “off-shore” services in an effort to speed development, reduce costs, while hoping to maintain a high level of quality. Today, the process of discovering and testing new drugs is following a similar path and India has a leading role.
There is a tremendous amount of excitement about markets such as India, Central and Eastern Europe and more recently, China. But like any new and exciting trend, we need to buffer that excitement with an understanding of reality. There are tremendous benefits being realized by companies now conducting studies in India, but those companies have also developed an understanding of the cultural intricacies, workforce talent pool, site and study conduct challenges and an improving yet dynamic regulatory environment. Understanding these realities and how to work in them is critical to future success.
India – A Preferred Destination: Why the Industry is Acting on India
As is widely known today, sponsors operating in mature drug development markets including the US and Western Europe are facing difficult challenges in moving their compounds efficiently through the pipeline, whether it be a shortage of beds for Phase I units, delays in contracting and budgeting, or patient recruitment challenges, the costs and timelines associated with bringing new compounds from the bench to bedside is greater than ever before. These issues have forced the industry out of its comfort zone resulting in a rapid globalization process over the last 10 years. Likewise, regions and countries around the world have adapted to and benefited from this globalization.
In very recent years, India has adapted its laws and regulatory guidelines to allow global biopharmaceutical companies access and confidence in conducting clinical trials there. Strong national resources and advantages in medical education and practice, patient populations and the prevalence of 1st and 3rd world diseases have made India not only an open destination, but also an attractive destination. In fact, the well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of key categories, including - perhaps most importantly to many companies - the regulatory environment and timelines.
Overall India advantages becoming known:
For additional information on this exciting market, please click one of the links below:
For a long time, India has been a hotbed for companies in several major industries looking to outsource and “off-shore” services in an effort to speed development, reduce costs, while hoping to maintain a high level of quality. Today, the process of discovering and testing new drugs is following a similar path and India has a leading role.
There is a tremendous amount of excitement about markets such as India, Central and Eastern Europe and more recently, China. But like any new and exciting trend, we need to buffer that excitement with an understanding of reality. There are tremendous benefits being realized by companies now conducting studies in India, but those companies have also developed an understanding of the cultural intricacies, workforce talent pool, site and study conduct challenges and an improving yet dynamic regulatory environment. Understanding these realities and how to work in them is critical to future success.
India – A Preferred Destination: Why the Industry is Acting on India
As is widely known today, sponsors operating in mature drug development markets including the US and Western Europe are facing difficult challenges in moving their compounds efficiently through the pipeline, whether it be a shortage of beds for Phase I units, delays in contracting and budgeting, or patient recruitment challenges, the costs and timelines associated with bringing new compounds from the bench to bedside is greater than ever before. These issues have forced the industry out of its comfort zone resulting in a rapid globalization process over the last 10 years. Likewise, regions and countries around the world have adapted to and benefited from this globalization.
In very recent years, India has adapted its laws and regulatory guidelines to allow global biopharmaceutical companies access and confidence in conducting clinical trials there. Strong national resources and advantages in medical education and practice, patient populations and the prevalence of 1st and 3rd world diseases have made India not only an open destination, but also an attractive destination. In fact, the well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of key categories, including - perhaps most importantly to many companies - the regulatory environment and timelines.
Overall India advantages becoming known:
- Well-credentialed, acclaimed physician base
- Growing market for patent-protected therapies
- Faster, cost-effective studies
- Marketing & Supply Chain infrastructure
- Large treatment-naïve patient population
For additional information on this exciting market, please click one of the links below:
Monday, January 5, 2009
The Importance of Strong Study Feasibility on Patient Enrollment in India
In order to understand which studies will enroll in India, you have to understand disease prevalence rates first. Unfortunately, India does not currently produce wide ranging information via government or industry organizations which will provide an accurate assessment of disease prevalence and incidence. Instead, a more classic feasibility must be conducted directly through the investigative sites. Many factors including newness of some sites, cultural customs and trust require the feasibility questionnaire to be distributed in person and information gathered through an interview rather than simply sending along a form via fax or email. Using an organization with personnel across the country and with good contacts at each of the sites can make the process more efficient and often result in better data. Like in the US, enrollment projections given by Indian investigators typically need to be scaled back considerably, but often the aggregate projections are still much higher. Good feasibility data will also include the meeting frequency of each sites IRBs (some IRBs may only meet once every 2-3 months) and the related fees, also an important part of getting the study up and running quickly.
This hands-on feasibility process typically results in the selection of better sites. But far greater in importance is the need for ongoing support of each site to ensure faster enrollment. As mentioned earlier, site management companies are now assisting sponsors with placement of a full time highly trained CRC at each site to work along side the investigator, conduct chart reviews, follow up with potential patients, conduct screenings and help administer informed consent among other things. This type of day-to-day support is essential to ensuring the right patients are enrolled.
To learn more about this topic and conduct a feasibility analysis in India, please click here.
This hands-on feasibility process typically results in the selection of better sites. But far greater in importance is the need for ongoing support of each site to ensure faster enrollment. As mentioned earlier, site management companies are now assisting sponsors with placement of a full time highly trained CRC at each site to work along side the investigator, conduct chart reviews, follow up with potential patients, conduct screenings and help administer informed consent among other things. This type of day-to-day support is essential to ensuring the right patients are enrolled.
To learn more about this topic and conduct a feasibility analysis in India, please click here.
Subscribe to:
Posts (Atom)
