We help in the preparation of a detailed Risk Management plan for identification of the possible challenges and product side effects with our dedicated & qualified pharmacovigilance team expertise.
We help you align your safety study plan with complete focus on clinical and safety studies and potential real-world evidence generated e to support value-based pricing agreements in your region. We help you blanket cover regulatory compliance, build product recognition and encourage usage with recommendations from health professionals.
We at COD research have Pharmacovigilance capabilities which reveal the true value of your product.
Our Pharmacovigilance Services Execution Services
Clinical Trial Safety Monitoring involves complete scope of activities
- Case report data collection and processing
- Adverse event and serious adverse event reporting in line with regulatory requirements.
- Well qualified personnel for providing QPPV services
- Document preparation for risk benefit evaluations, NDA submissions and labelling submissions
We provide end-to-end cost effective post-marketing pharmacovigilance services which includes
- AE Data Migration
- Case intake
- Literature search
- ICSR processing
- Medical coding,
- Quality review & Medical Review
- Regulatory submission
- Social media screening
We have extensive therapeutic experience in providing provide Drug Safety consulting system to meet overall client and regulatory requirements.
COD capabilities in this area include:
- Development of Standard Operating Procedures & working practices for PV
- Training
- Audit and compliance
- Project management
- Clinical Trials Feasibility and Monitoring,
- Regulatory Affairs Support & Safety data exchange agreements
- Signal management for Risk minimisation activities
- Maintenance of datasheet and labelling.
COD’s team is well equipped with trained professionals to provide high-quality services:
- Global & Multilingual Support
- MI / AE / PQCs
- Follow-up Calls
- Targeted Questionnaires
- FAQs, Standard response letter, customized responses
We provide a complete comprehensive solution for aggregate reporting which includes
- Periodic benefit/risk evaluation reports (PBRERs)
- Periodic safety update reports (PSURs)
- Periodic adverse drug experience reports (PADERs)
- IND annual safety reports
- Pharmacovigilance risk assessment committee (PRAC) responses & health authority responses
- Support for risk management plans (RMPs) & REMS
- Developmental safety update reports (DSURs)
- Risk benefit profile reports, Literature search, analyses & ad hoc risk benefit assessments
- Data analysis & risk communications to client and regulatory authorities
04Latest Happenings at COD Research
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Since its inception in 2017, COD Research has been achieving enviable milestones, opening new avenues in the field of clinical research.