outsourcing process.Career prospectswith CROs and site management organi-zations (SMOs) in India are quite attrac-tive,considering the number ofclinicaltrials currently under way in India indiverse therapeutic areas (Figure 4).India has also created a niche for itself in the bioanalytical and bioequivalencebusiness,through cost effectiveness andthe ready availability ofhealthy trialsubjects.There are more than 15 rep-utable centers for such studies in India,specializing in short-term trials thatgenerate quick revenue.These centersneed CRAs,physicians,phlebotomists,nurses,quality assurance auditors,prin-cipal investigators,pathologists,bio-chemists,laboratory technicians,andbiostatisticians.
Many sponsors have started usingIndian centers ofexcellence to save timeand money on their biometrics needs.This has created a huge number ofjobsin data entry,data management,pro-gramming,coding,statistical analysis,and medical writing,as well as opportu-nities in database and statistical analysissystem training.The growing trend forEDC will attract more skilled profession-als who understand the software and theintricacies ofinstalling,implementing,and training users (investigators andmonitors) to use it effectively.
This industry is heavily dependent onanother set ofresources:investigatorswith strong inclinations toward the con-duct ofethical clinical research.Hence,this industry looks for experienced prin-cipal investigators who have set up andconducted global clinical trials and havecompetent study staffat their sites.Ten years ago,it was very difficult to find aprincipal investigator who had workedon GCP trials.Recently,however,CROsand global pharmaceutical companieshave started working with clinicians andphysicians in different therapeutic ﬁeldsin an effort to familiarize these invest-igators with GCP and International Con-ference on Harmonization (ICH) E6Guidelines.
The growing clinical research sectorhas propelled the emergence ofmany ancillary career opportunities in centrallaboratories,investigational productmanufacture,packaging,warehousing,distribution,and refrigeration serviceproviders.Other critical support servicesthat translate to business opportunitiesin India involve translating and printingclinical trial materials,providing cogni-tive testing,validating rating scales andquality-of-life questionnaires in locallanguages,storing trial materials on along-term basis,forming centralizedethics committees,managing accredita-
Figure 3.Demand-Supply Gap 2010 in India
Chiltern International India Estimates.
Sponsor Staff CRO Staff InvestigatorOther Site Staff 2001,0003004001,0006,0002,0004,000DemandSupply
Figure 4.Clinical Trials Done in India
Clinical Trial Registry,www.clinicaltrials.gov,accessed in January 2007.