Medical evaluation and expertise for standalone service or end-to-end clinical trials and its 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
● Patient based generic molecule studies
● To review and provide medical inputs in clinical documents prepared by medical writing team
Activities
● 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
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.
