About ClinDeRisk
At the interface of basic science, non-clinical safety, clinical development and pharmacovigilance, ClinDeRisk provides focused strategic advisory to anticipate, characterize and mitigate development risks with a translational safety approach.
The goal is not routine pharmacovigilance operations.
The goal is to strengthen development decisions, improve risk understanding, and support credible safety positioning, while avoiding costly late-stage crises modes or reputational damage by anticipating and mitigating risks early.
What makes ClinDeRisk different
-
What ClinDeRisk brings
Proactive analysis of reasonably foreseeable risks, and scientific guidance for unexpected safety signals emerging during development, review scientific aspects of clinical risks within clinical safety reports (CSR).
-
What ClinDeRisk does not do
Routine pharmacovigilance operations, periodic reporting, protocol writing or CSR production.
Meet the founder
ClinDeRisk Advisory was founded by Hervé Bester, MD, PhD.
Physician, neuroscientist and former senior drug safety leader with more than 20 years of experience spanning translational research, clinical development safety, risk management and pharmacovigilance.
Founder & Consultant of ClinDeRisk Advisory, based in Orsay, France.
Former Vice President and Global Patient Safety Rare Disease Therapeutic Area Head at Ipsen, where he co-led the creation of a Translational Safety group, he previously held global safety leadership roles at SANOFI across development and post-marketing settings, with extensive exposure to regulatory dialogue, signal detection, benefit/risk evaluation and cross-functional decision-making.
A broad operating background
His experience spans biotech and pharma development, post-marketing safety, due diligence and translational risk anticipation, from preclinical data through clinical strategy.
A strong scientific foundation
Before taking on senior clinical safety leadership roles, he earned a PhD in Neuroscience focused on pain, followed by a postdoctoral fellowship at University College London (UCL). He then led preclinical neuroscience research teams in pain and epilepsy, supporting a mechanistic, pathophysiology-based approach.
What this means for clients
Clients benefit from founder-led consulting that combines medical judgement, scientific depth, translational thinking and practical development risk management for both human and veterinary programs.
Let’s talk about your project
Share your project, asset, question or due diligence need.
A tailored response starts with a focused conversation.