Quintessentially responsible for the development, writing, review and interpretation of standalone or end-to-end clinical documents for scientific accuracy and precision, and meeting the regulatory compliance across therapeutic indications.
Studies
● Proof of concept studies
● Drug phase trials (I to IV)
● Medical device trials OR Drug-device combination trials
● Post marketing commitment trials
● Academic clinical trials
● Patient based generic molecule studies
● Topline/detailed feasibility with development of concept sheet based on extensive literature search and medical expert inputs
Activities
● Investigator’s brochures (IB)
● Investigational medicinal product dossier (IMPD)
● Clinical study protocols
● Clinical investigational plan
● Consent documents, patient scales, patient diary cards, and other documentation along these lines
● Comprehensive (ICH-E3 compliant) / Abbreviated / Synoptic clinical study reports
● Clinical Investigation Reports
● Clinical and non-clinical summaries and overviews of the Common Technical Document (CTD)
● Preparation of briefing documents for various regulatory agencies
● Regulatory query responses
Sponsor request for particular service
RFI shared to sponsor
RFP from sponsor
Scope alignment between sponsor & CRO
Budget discussion & finalization
Service awarded to COD
KOM & delegation
Document preparation & service execution
Report preparation & finalization
Regulatory submission & support till approval
Different models
to meet diverse needs
to meet diverse needs
Different partnerships
to meet diverse needs
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
