India has emerged as the favorable destination and new global hub for Clinical Research business for a decade and has been tremendously growing for past 2 to 3 years.  Contract Clinical Research relatively is a new business and profession in India but according to projections by McKinsey & Company, the Indian Clinical Research Industry could attract US $1.5 billion of revenue from the worldwide Pharmaceutical & CRO Industry creating job opportunities for more than 10,000 Principal Investigators and nearly 50,000 Clinical Research Professionals, who are trained in Clinical Research including ICH-GCP/ FDA guidelines.

If India’s clinical trial business grows to 10% of the scope seen in the U.S. by 2010 according to McKinsey’s projections, then the industry will need approximately 50,000 recruits.  India has a huge pool of scientific, pharmaceutical, and medical talent, but the supply of trained professionals in India is approximately one-tenth of its demand. Unless research training institutes are established, this huge gap between the demand and supply of trained personnel cannot be bridged.  Most global pharmaceutical companies conducting multi-center studies in India have big and small Clinical Research Departments handling regulatory and marketing support, local Pharmaco-vigilance reporting, conduct of local registration, and post-marketing surveillance studies.  This team coordinates with its global project management or outsourcing partners to mentor, maintain timelines, ensure checks and balances for regulatory compliance, and collect quality data.  The outsourcing decisions for these global studies are mostly made in the U.S. and Europe; however, as India becomes a major hub and contributes further to subject recruitment in clinical studies, Indians will play a much larger role in the outsourcing process. 

The Future Outlook:  Indian CROs v/s Outsourced Projects from Europe & USA:

Acceptance of the clinical research profession by young life sciences, pharma & medical graduates is growing fast. More universities and institutions can be expected to introduce full-time courses for students to help supply the industry’s needs on a continuous basis.  As has been seen with IT professionals, this resource pool is also becoming source of pride for India that is recognized globally for its sincerity, scientific knowledge, and skills.  Although there are often differences between the clinical research professionals of India and western countries in terms of their levels of direct experience in trials and their understanding of the complexities of the drug development process, India is rapidly improving upon this situation as it seeks to one day emerge as a global leader in the CRO industry.

Unlike software/ IT industry, which are completely dependent on American and European clients, Clinical Research Industry is not completely dependent.  India has major giant pharma companies who themselves have their own CRO establishments.
Opportunities, Perks, Growth & Career Prospects:

Career prospects with CROs and site management organizations (SMOs) in India are quite attractive, considering the number of clinical trials currently underway in India in diverse therapeutic areas.  There are more than 360 big and small CROs in Mumbai, Delhi, Gurgaon, Noida, Hyderabad and Bangalore.  India has also created a niche for itself in the Bio-analytical and Bio-equivalence business, through cost effectiveness and the ready availability of healthy trial subjects.  There are more than 20 big reputed centers for such studies in India, specializing in short-term trials that generate quick revenue. These centers need CRAs, physicians, phlebotomists, nurses, quality assurance auditors, principal investigators, pathologists, biochemists, laboratory technicians, and biostatisticians.  Many sponsors have started using Indian centers of excellence to save time and money on their biometrics needs. This has created a huge number of jobs in data entry, data management, programming, coding, statistical analysis, and medical writing, as well as opportunities in database and statistical analysis system training.  The growing trend for EDC will attract more skilled professionals who understand the software and the intricacies of installing, implementing, and training users (investigators and monitors) to use it effectively.  This industry is heavily dependent on another set of resources: investigators with strong inclination toward the conduct of ethical clinical research. Hence, this industry looks for experienced principal investigators who have set up and conducted global clinical trials and have competent study staff at their sites. Ten years ago, it was very difficult to find a principal investigator who had worked on GCP trials.  Recently, however, CROs and global pharmaceutical companies have started working with clinicians and physicians in different therapeutic fields in an effort to familiarize these investigators with GCP and International Conference on Harmonization (ICH) E6 Guidelines.

There are multiple job opportunities available for monitors in the current scenario.  A professional with a few years of experience can quickly be absorbed by CROs, Data management firms, and even IT companies with lifescience and clinical specializations.  This has led to salary hikes and upgraded positions.

Strong skill sets and careful attention to the complexities of handling trials have taken a back seat to the lure of money, driving clinical research professionals to acquire higher positions and pay packages.  Thus, the clinical research industry is facing a challenge of huge attrition. The Financial Express says the attrition rate has grown three times in the last two years, and is even higher than in the Indian IT sector. 

Attrition is higher in CRA and project manager positions, as these two professions have changed over a decade. And with mushrooming growth of CROs, there is high demand for trained Clinical Research Professionals and also Heads of operations, which leads to the poaching of trained professionals at all levels.  Salaries in CRO industry are on par with IT industry ranging from Rs. 15000 to more than Rs. 50,000 per month to start with.

Few of the reputed Big Clinical Research Players in India:
     
Pharmaceutical Companies: Pfizer, Eli Lilly, Dabur, Novartis, Dr Reddy’s, Ranbaxy, Sanofi Aventis, Astra Zeneca, Torrent, Zydus, Altana, Sun, Merck, GSK, Wyeth, Credence, Auron Healthcare, Claris Lifescience, Lupin, Galderma, Aurobindo Pharma,

Clinical CRO (Global) Quintiles, Chiltern, PPD, Covance, Pharmanet, Parexel, ICON, Kendle, Pharm Olam, IGate, KARD Scientific, PRA International, Inversk
 
Site Management Neeman Medical, Odyssey Research, Accunova, SMO India

Organization (SMO)

Clinical CRO (Indian) SIRO, Synchron, ClinInvent, Sterling, Clingene, ClinWorld, ClinRx, Clintec,Pharma Intel,ACT/Suven, Reliance, Apothecaries, Clinquest, Clinsys, SpaceLabs, Manipal Acunova, Trident Life Sciences, Symogen, RPM Alliance, MakroCare, Wockhardt, Novartis, Parexel 

Bioequivalence /
Bio- availability CRO Synchron, Lambda Therapeutics, Lotus Lab,Vimta Lab,Wellquest, Jubilant, LG   Lifescience, Trident Life Sciences,

Discovery /Chemistry/Toxicology CRO  Chembiotec, DnO, Rallis Research, Avra, Indian Institute of Toxicology, Intox, Syngene/Biocon, Aurigene/Dr Reddy’s, Medreich, Rubicon, Natco, Bilcare

Clinical Data Management/ SIRO Quintiles, Synchron, Cognizant, Accenture, DnO, Data

Pharmacovigilance Monitor, ClinInvent, TCS, IBM, HCL, Infosys, Persistent Technologies,
Sristek, Symogen, Satyam Computers, Laxai

Central Laboratories Ranbaxy, Clinigene International, Metropolis Health Services,  Max Healthcare, Dr Lal’s  Pathlab

Biotech Companies Biocon, Shanta Biotec, Bharat Serums & Vaccines, Panacea Biotech, Wipro Healthscience, Haffkine Bio-Pharmaceuticals, GVK Bio, Krebs Biochemicals, Bio-Rad Labs, Indian Immunological

(Source: Chiltern International Private Limited, India)

CR CAREER PATHWAYS:

Global players attempt to attract experienced talent by offering competitive salaries and providing exposure to global work in process and systems. By contrast, domestic players attract experienced professionals from CROs and global pharmaceutical companies with even higher salaries and prestigious designations.  Attrition causes instability; hence, organizations in India and abroad are seeking innovative ways to reduce the attrition rate through better salaries, training, learning opportunities, attention to employees’ personal needs, and enhancement of employees’ global exposure.

Clinical Operations:  CROs/Pharma Companies/ Site Management Organization

Clinical Trial Assistant (CTA) c Clinical Research Associate (CRA) c Senior CRA
c Clinical Team Leader  c Project Manager
c Senior Project Manager c Medical & Regulatory  Manager c Quality Assurance Manager
c Medical Director c Associate Director— Clinical c Associate Director-Projects

c Director—Business
Development c Director/Head (Clinical Operations) c General Manger/CEO/

Clinical Data Management/ Biostatistics (SAS) & Oracle Clinical Programming

c  Data Management Associate   c Data Manager c Data Validation Executive
c QA Executive c QA Manager c Statistical Programmer c Statistician
c Data Reviewer c Data Base Designer c Medical Writer c Head—Data Management

CR Training Institutes in Andhra Pradesh:  Asian Institute of Clinical Research, Above British Library, Hyderabad, Sikkim Manipal University, Hyderabad, Rx Professions Clinical Research Academy & SOCRA Hyderabad, Bilcare Research Academy, Pune University, LV Prasad Eye Institute  and others.

Clinical Research Training and Courses Offered in Andhra Pradesh, India

Clinical research training is another important issue, given the gap between supply and demand for trained professionals in India.  To foster expertise in clinical research, organizations have started training their employees in ICH and GCP guidelines and company policies, then exposing them to hands-on training in their respective departments:- Clinical Operations, Clinical Data Management, Regulatory or Medical Affairs. Most of the global players do not have proper training divisions and having hard-time to because of their hectic schedules and projects.  The overseas and local Clinical Research Academies and Institutes have been helping CROs to fill their manpower demand-supply gaps via customized Training Programs.
Until recently, there were no structured, formal training courses focusing only on clinical research. The training efforts by the Medical Institutions, CROs and big pharmaceutical companies have shaped the profession.  Looking at the growth prospects in this industry, many overseas and local universities and global training institutes have started full-time, short-term P.G. Diploma & Diploma courses (classroom based and/or online) in clinical research management and Rx Professions Clinical Research Academy at Hyderabad & Guntur and Asian Institute of Clinical Research being few of them having affiliation and certification partnerships with SoCRA of USA and Drexel Medical University of USA. 
Webs: www.drexel.com/rxp

However, the real challenge for the industry is to create quality resources through proper training and exposure.  Life Sciences graduates, Post-graduates, Pharma and Medical Graduates are eligible to enroll in the training programs in Clinical Research.

Rx Professions Private Limited is Clinical Research Organization and Institute at Hyderabad with branch office and franchisee academy in Guntur.  We are into Clinical Trials Site Management and Research Activities, with Training being our major activity.  Rx Professions Clinical Research Academy has been conducting free seminars at all Pharma, Life Sciences and Medical Colleges in Andhra Pradesh to create awareness about practice of ethics in Clinical Research Academy and is currently offering Advanced P.G. Diploma in Clinical Research affiliated to SoCRA of USA (www.rxprofessions.org) at Hyderabad and Guntur which is a 6-month program and includes in-depth curriculum as per the CRO industry’s requirements and ICH-GCP standards in

affiliation with SoCRA.

Sources & References

1. Monitor – by Sahoo of Chiltren, White Paper on Global Clinical Trials in India : Prospects and Challenges. BioBusiness Summit 2005, 14-15 Nov, 2005; Federation House, FICCI, New Delhi , India.
2. Sahoo U. 2005. Look East for the future development of new drugs and speedy clinical trials. Pharmaceutical Journal 275, 26 November 2005.  
3. Montagne M. 1996. The role of clinical research in the drug development process. In Bleidt B and Montagne M, eds. Clinical Research in Pharmaceutical Development. New York :Marcel Dekker.
4. Sahoo U. 2005. Careers in clinical research— India . The Monitor 19(4): 37-42.  
5. Clinical Research Jobs in the New Economy . 2001.. A Special CenterWatch Report. Center-Watch 8(9): September 2001.  
6. Bhatt A, Sahoo U. 2004. 2010: Indian clinical research odyssey. Pharmabiz , February, 26, 2004
7. Takoo M, Mirashi M, Sahoo U. 2006. Bioavailability and bioequivalence trials: a promising business opportunity in India . The Monitor 20(3): 43-6.  
8. Sahoo U. 2005. Data capture shifts paradigm, EDC vendors eyeing India . Chronicle Pharmabiz Asia, July 2005. 
9. Sawant D. 2006. Human resource—a growing need. Chronicle Pharmabiz , India Calling. A Pharmabiz Special Exclusive to CphI , p55, Sep 28, 2006 .
10. Sahoo U, Sanghavi V, Kermani F 2006. Subject recruitment: an Indian perspective. Applied Clinical Trials 2006.
11. Sahoo U. 2005. Indian CRO industry: the talent pool. Global Outsourcing Review.