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Ethitrials Contract Research Pvt.
Clinical research
Ahmedabad
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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.
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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
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Medical review of clinical study report
Operations
c) Site feasibility and selection
Site management activities
Project management
Data management and biostatistics
d) IP management
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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
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