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Ethitrials Contract Research Pvt.
Clinical research

Ahmedabad

Ethitrials has a broad service foot-print in clinical research and pharmaceutical marketing industry. It was established in 2011 with a drive to provide quality services in the most ethical way. The team has experience across all stages of development for drugs, devices and biologics with broad range of therapeutic area. Dr. Bhaumik Mody is a CEO of ECRPL. He is a medical professional with post-graduation in Clinical Research and Regulatory Affairs. He has abundant experience in managing large teams involved in medical writing, CRA, data management and pharmacy professionals too. ECRPL provides advice to BETiC in preclinical and clinical trials of medical devices being developed.
Clinical Trial Management a) Medical Writing Study designing and conceptualization Regulatory dossier preparation (Protocol, PIS-ICF, CRF, IB, Patient diaries, study rationale etc.) Regulatory dossier presentation (NDAC, SEC etc.) b) Safety narratives Preparation and updation of CTD
Medical review of clinical study report Operations c) Site feasibility and selection Site management activities Project management Data management and biostatistics d) IP management
Training Good Clinical Practice / Advanced GCP Good Laboratory Practice/ Advanced GLP Good Clinical Laboratory Practice Good documentation practice Recent advances in Indian regulatory environment SOP development and training