Ensuring Clinical Safety & PV Compliance
Comprehensive Support for Vendor Onboarding & Oversight
Comprehensive Support for Seamless Vendor Onboarding & Oversight
We provide comprehensive clinical safety support throughout the clinical development process. Whether acting as your dedicated pharmacovigilance (PV) team or strengthening your existing PV operations, we help establish robust oversight, seamlessly onboard PV vendors, and ensure full compliance with sponsor responsibilities. Our expertise ensures your safety processes are efficient, compliant, and aligned with regulatory expectations.
Our Clinical Development Safety leads
Seema Jaitly
Pharmacovigilance Physician
Bill Richardson
Pharmacovigilance Physician
Varsha Vasi
Pharmacovigilance Physician
Our Clinical Safety Support Services
Regulatory & Safety Documentation
- Review of Investigator’s Brochure (IB), Protocol, Statistical Analysis Plan (SAP), Safety Management Plan (SMP),and Informed Consent (IC) Forms
- Development of Safety Sections for Product Information (SPC, USPI, CCDS, RSI)
- Review of Clinical Study Reports (CSR), including Case Narratives
- Clinical Overview and Integrated Summary of Safety (ISS)
Safety Oversight & Risk Management
- Pharmacovigilance (PV) Vendor Oversight and CRO Safety Vendor Guidance
- Sponsor Quality Management System (QMS) Set-up
- Signal Detection & Management in Clinical Trials
- Benefit-Risk Assessment
- Assessment of Clinical Holds and Urgent Safety Measures (USM)
Safety Reporting & Compliance
- Development Safety Update Reports (DSUR) / Annual Safety Reports (ASR)
- Individual Case Safety Report (ICSR) / Serious Adverse Event (SAE) Medical Review
- Responding to Safety Questions during BLA/NDA/MAA Submissions
Training & Process Optimisation
- Adverse Event (AE) Training for Clinical Teams
- Electronic Case Report Form (eCRF) Review
