Clinical trial industry in India has seen much ebb-and-flow in the last 15 years. During 2003 - 2010, in terms of financial turnover; industry has grown over 100 times at the rate of 1414 per cent annually (Bajpai V, ISRN Public Health Volume 2013, Article ID 167059).  In 2005, India was considered third most preferred country for R&D related investments globally after China and the US (in a survey of leading R&D, by The United Nations Conference on Trade and Development). These expectations increased tremendous load on HRD for hiring qualified job seekers, and also generated opportunities for educational industries as an expedited requirement. In the initial stage, candidates with life sciences graduation and basic knowledge of drug development processes were considered importunate for breaks. But after 2006, demand of clinical research industry was avid, expecting trained candidates.

In 2013, after repetitive media outcry health authorities in India have undergone long lasted regulatory system up-gradation. These changes came like twister for clinical research and related industries, which converted status of individual player from well growing to acquired or closed. Lots of international sponsors withdrew their projects from their Indian subsidiaries or CROs because of delay in regulatory approval. On the contrary, medical writing, CDM and pharmacovigilance consultants grew well and expanded during this period, because of their regulatory undependability.

Now, the modified system is in place and industries are settled with new regulatory obligations. The impact taught industry to reduce its dependency on similar type of work. CROs are segregating themselves to cope up with industry expectations. The clinical trial industry is wide and requires expertise in all areas. Multifunctional CROs consist of full-fledged segregated units favoured by sponsors, because of expertise and ability of non-overlapping. Karmic Lifesciences LLP is multifunctional segregated CRO (part of Cliantha Research Ltd) having expertise in conducting nutraceutical, herbal, cosmetic and personal health care projects, however Cliantha research takes care of all types of pharmaceutical clinical trials. Additionally, Karmic is also involved in third party auditing, monitoring and training services. Clinical data management & biostatistics has also been a core service. In last six months Karmic Medical Affairs Department has completed more than 80 assignments in medical communication writing, with 15 publications in well esteemed journals. Karmic’s patented kTrials system is US FDA 21 CFR Part 11, CDASH/CDISC & SDTM Complaint System. This framework is employer friendly and improves scientific skills and expertise in functional areas. Further, this approach has been appreciated by sponsor as it helps them in method and product development.  

Current, clinical trial educational institutions should understand this requirement and differentiate their syllabus accordingly, as the generalize education may restrict the thinking of young researcher.