Meet with Adnovate CMO Neurology, Samer Kaba, at the CMO Summit in Boston. April 17-18, 2024.

Adnovate Clinical Data Privacy Policy

Meet Adnovate Clinical Founder Ajay Duggal at Longwood Healthcare Leaders Spring MIT in Cambridge. June 17-18, 2024.

From GCP to GVP Whitepaper: A Pharmacovigilance Guide for Emerging Biotech Firms Transitioning from clinical development to post-marketing represents a critical phase for emerging biotech companies, demanding the establishment of robust pharmacovigilance (PV) systems. Given the resource and expertise constraints often faced by smaller biotech firms, outsourcing to Contract Research Organizations (CROs) emerges as a viable solution. However, this approach introduces its own set of challenges, including maintaining control, ensuring quality, and managing flexibility. This whitepaper explores strategic considerations and practical steps to optimize PV activities outsourcing. It aims to guide biotech executives through the challenges of selecting operating models that align with their company’s objectives, regulatory demands, and market dynamics. The paper discusses the balance between leveraging external expertise and retaining crucial oversight of PV operations.