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Medical evaluation and expertise for standalone service or end-to-end clinical trials and its 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

● Patient based generic molecule studies

● To review and provide medical inputs in clinical documents prepared by medical writing team


● To provide medical inputs for sample size estimation (e.g. consideration of clinically meaningful difference expected for a test treatment)

● Preparation of Medical Monitoring Plan (MMP) and Safety Management Plan (SMP) in line with clinical study protocol or clinical investigational plan

● 24 x 7 availability over a call through Medical Information System (MIS)

● Subject eligibility review

● 24 x 7 availability for discussion & response to medical emergencies protocol deviation review and discussion

● Clinical case or CRF review for an individual subject/patient

● Medical line listing review and discussion

● Safety line listing review and discussion

● Medical coding review

● Review of serious adverse event / pregnancy cases

● AESI review in a clinical trial

● Review of emergency unblinding request

● Development and delivery of CIOMS

● Analysis of similar events and its review

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.