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
Wednesday, January 14, 2009
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.
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