EXPERTISE

We are currently working with an Indian Stem Cell company providing them with end-to-end services for their Phase II Clinical Trial
We have successfully completed a series of studies for an Indian Pharmaceutical Company in areas of Respiratory, Cardiology, Neurology, Oncology, Gastroenterology and General Medicine
We have conducted Bio-Equivalence studies for various Indian manufacturers for export markets
We have executed more than 15 DCGI submissions for Ajanta Pharma in various therapeutic areas. We have also supported them in receiving marketing approval for 2 of their ophthalmic formulations
Have successfully executed RWS for Macleods for various products
We have successfully completed a ICMR supported medical device study for an Indian client for their safety syringe product
We have successfully completed various claim substantiation studies for big brands

Have strong understanding and knowledge of the vaccine trials and 20+ years of experience in conduct of clinical trials across various continents
Have strong knowledge and experience of more than 25+ years in the field of pathology enabling the best of the tests and kits be available for the study
Have NABL accredited central laboratory based in Thane for all immunogenicity testing which increases the credibility of the key study objectives
Various novel approaches to collect reactogenicity data especially within the first 7 days of the vaccine administration
Strong Medical writing team with experience to prepare Phase II and Phase III protocols for critical diseases
Experienced PI’s (who have worked for vaccine trials in infants, paediatrics, adolescents and adults) and site teams for daily on – site co-ordination
Experienced operations team providing single point of contact for individual site related updates
Strong regulatory background and support to handle SEC meetings
Continued support for PSUR and SUSAR preparation and submission