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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.


● 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


● 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

Insights &

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.