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Human resource - a growing needThursday, September 28, 2006 08:00 IST Contract research organization (CRO) is one that manages a research or an investigation to assess and / or verify the clinical, pharmacological or other pharmacodynamic effects, safety and / or efficacy and adverse reactions of an investigational product or study drug. India has the advantage of welcoming CRO industry as there is a high potential for conducting clinical trials in India because of qualified professionals, infrastructure, regulations and standards, patient population and most importantly the high quality data. According to McKinsey report the clinical research industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next five years. Analysts project that by 2008 up to 30 percent of global clinical trials will take place outside US and Western Europe and India would emerge a favorable destination. India is witnessing this positive trend which is reflected by growing numbers of players - global and local CROs, currently providing a spectrum of clinical development services at different stages of drug development, viz. project management, clinical trial monitoring, medical affairs, regulatory, clinical trial supplies, quality assurance, data management and statistical analysis. Most companies acknowledge that knowledge process outsourcing to India not only minimizes the cost, but also propels the growth of the organization. With this growth in knowledge process outsourcing, there is a constant demand of human resources in India. There is no dearth of knowledgeable and educated professionals in India. But the sudden skewed growth in this segment of CRO business has put lot of demand for skilled professionals, which are not existent in sufficient numbers in Indian market. The available pool of human resources mainly comprises of pharmacy graduates or graduates in biological sciences, post - graduates and/or doctorates, medical doctors, statisticians and software engineers. Depending upon their qualification and experience they are assigned the job responsibilities. Every clinical project taken up by the employee is a learning experience through which one gets to learn about the activities performed by the other functional groups during the conduct of the trial. If an individual has put in years in the clinical operation department, is highly experienced and is aware of the regulations and standards, then that individual through experience can gain knowledge of regulatory affairs, clinical trial supplies management, quality assurance and data management and hence can also perform cross-functional tasks. However, freshers, who desire to join this industry, wish to start their careers through clinical operations. The craving for clinical operations is because of huge demand for Clinical Research Associates (CRAs) in the market today. But looking at the current business expansion, the industry may demand professionals for other service offerings like QA, pharmacovigilance and regulatory affairs as well. Training and courses offered in India Training is a continuous process. Every organization should be prepared to develop human resources. If trained resources are scarce, it's the duty of the organization to recruit and train candidates as per organizational requirements. Till recently, there were no structured formal training courses focusing only on clinical research. But now with growing awareness of clinical research, there have been many clinical research courses introduced in India. To name a few there are; Academia of Clinical Excellence (ACE), Catalyst Clinical Services, Institute of Clinical Research India (ICRI), Kriger Research Institute, Kundnani College of Pharmacy, Bioinformatics Centre, University of Pune and Bioinformatics Institute of India. Syanapse in Delhi and Watsallya Institute Banglore offer Post Graduate diploma course. The duration of these courses vary from 6 months to 1 year and the cost also ranges between Rs 40000 to Rs 200000. ACE and ICRI, and Bioinformatics Centre offers post-graduate courses in clinical research management and data management. Whereas Bioinformatics Institute of India conducts industry program in clinical trialr Research and administration. Certification offered to clinical research professionals In today's competitive environment, there is a growing trend of specialized skill sets. There have been various certification course introduced which helps an individual after getting certified to get himself/herself recognized in this industry and also adds value to the company in which they are working for. As the competency in this field has increased, more and more clinical research professionals are getting enrolled themselves in Associations of clinical research group and getting themselves certified. There are few certification courses available like ACRP and some institutes such as; Kriger Research Institute and Pharmaschool, who conduct online examinations. Such Institutes provide a wide range of clinical research related training solutions to the global pharma, CROs and health care industries. Recruitment of investigators The talent search in this industry does not limit only to clinical operations management and data management, but goes beyond the CRO and pharma company. This industry is heavily dependent on another set of resources, which are popularly called as Investigators, essentially the doctors who have high inclination towards conduct of ethical clinical research. Hence, this industry looks for experienced principal investigators who have conducted global clinical trials in their set-up and also who have competent study staff at their site. Ten years back it was very difficult to find a Principal Investigator who has worked on Good Clinical Practices (GCP) Trial. But in the last few years the CROs / global pharma companies have started working with clinicians / physicians in different therapeutic field and to be on the global platform have taken efforts to train these Investigators on GCP and ICH E6 Guidelines. It is also appreciable that the Indian physicians have shown interest in learning GCP and conducting trials as per the regulations. Many principal investigators from India have got themselves certified as "Certified Clinical Research Investigator". Now-a-days CRO / pharma company have their own investigator database and dedicated network of investigators through which they contact the clinicians of the required therapeutic area to conduct clinical trials. Global companies eyeing India Many of the CROs are aware of the importance of good clinical practices and compliance to these is a standard requirement. Even the Government of India, industry associations and other stakeholders are initiating various programmes for drawing attention to GCP awareness and compliance by CROs. Even online programmes are available through various service providers. These programmes are proving fruitful. Indian CROs are creating and setting standards in their services. Data generated in India is accepted even in the US. This shows that the data acceptance has become global. It can be noted that USFDA doesn't give blanket recognition to any CRO, but the CROs qualify on project / audit basis. And hence more and more global CROs / pharma companies are approaching India. Many new players are entering into the CRO business every year. CRO industry is still an evolving business, unlike pharma and bio-pharmaceuticals in India, which are already well established. The industry is now able to attract business opportunities across the globe. Contract research is an evolving business, we need to train in order to meet our requirements. Average growth rate of the industry has been 30-40 per cent with the growing business. CROs should be equipped with adequate, trained manpower as per the requirements of the market. Future Outlook The number of qualified professionals entering into this field has increased since last 10 years. Initially there were freshers who would enter into the industry and the company had to utilize their time, money and efforts for orientation and training. But the scenario has changed now; we have qualified professionals who are also diploma holders or have done basic course in clinical research. The clinicians / principal investigators are also well versed with GCP and the most important being the official language of communication is English in India. Hence global companies are looking forward to work with India mainly because of the qualified professionals, experienced Principal Investigators and also because of large patient population. One should remember that CRO is a service sector. Short-term gains cannot be the goal of any CRO but quality and consistency of service can only fetch further business. (The author is Clinical Team Leader, Chiltern International Pvt. Ltd, Mumbai.)
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