Being a full-fledged CRO, developmental safety is a natural progressive line for us. Our team has the hands-on talent to work in early and late-phase clinical trials to ensure safety monitoring.
CT Initiation Support
Our CT and PV Experts, along with Medical Monitors, develop a pragmatic plan on safety management to foster correct safety information collection.
● Safety Management Plan (SMP)
● Site training for AE/SAE assessment and safety reporting
● 24*7 Clinical Site Inquiry Support
EU CT Portal Management Support
COD Research provides RPEV services for their European CT partners. COD has in-house RPEV, is certified with EMA knowledge certification, and has hands-on experience in managing Eudravigilance.
● RPEV (Responsible Person for EudraVigilance )
● CTIS Portal Management
● ASR Submission
CT AE/SAE Management
Our team of safety CT physicians and pharmacists manage AE/SAE straight from case receipt to submission globally. With categorical experience in processing SUSAR with AOSE, trial compliance are in safe hands when CT Processing is considered. The team has experience working on five different safety databases, making them versatile to act as FSP experts as per necessity.
● AE/SAE Processing
● SUSAR Processing and submission
● AOSE Preparation
CT Medical Safety
COD Research considers itself an expert when it comes to the Medical Safety aspect, as we have collective experience in supporting DSUR/ASR/LLR/DRMP preparation, expert review, and submission support.
Our experience varies from drugs, combination products, vaccines, biosimilars, biologics, nutraceuticals, and cosmetic products.
● Periodic Safety Listing Review
● SAR/SUSAR Line Listing Report
● Risk Management Strategies
● Development Safety Update Report (DSUR)
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.
