Showing posts with label CRO India. Show all posts
Showing posts with label CRO India. Show all posts
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.
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
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
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