Practice Areas
Provides tailor-made support in a wide range of drug development, clinical operations, market access and medical affairs activities
Clinical Development management
- Portfolio/project evaluation
- Clinical development plan management for NCE, biosimilars, generics, devices, biomarkers… from early clinical stage to licensing phase and life-cycle management
- Translational medicine and early clinical research experience
- Preclinical requirements: toxicity studies, animal models and PK, safety pharmacology
- All types of phase I : MAD, SAD, ADME, Food effect, TQT, specific populations, Drug Drug interactions, abuse liability, palatability,…
- Phase II Proof of concept trials design
- Phase IIB and Phase III trials design, choice of the endpoints, sample size estimation
- Strategic scientific positioning : providing strategic direction across therapeutic projects and defining the target product profile
- Protocol design : writing of the synopsis, selection of essential criteria for determining the safety, efficacy, and medical utilities. Study design and sample size determination
- Review of data analysis and results presentation
Clinical Operations management
- Management of clinical operations, pharmacovigilance, and QA : thorough knowledge of clinical trial processes including a strong grasp of international guidelines and regulations (ICH, GCP and EMA, FDA guidances)
- Selection of CROs, BID defense, budget estimation
Advice for Regulatory Strategy
- Regulatory strategy and interactions with agencies (EMA, FDA or national agencies)
- for all types of process such IND or CTA, Advisory meetings, ODD, BTD, NDA or MAA, PSP or PIP, RMP,…
Medical writing
- Design, drafting or review of all clinical documentation : synopsis, protocols, IB, CTA, IND, CSR, CTD, ISS, ISE, clinical expert reports, Brieffing packages, publications …
Market Access
- Market access assessment since early development to provide compelling and real-life evidence of a drug’s superior value
- Early access programs management (compassionate use, ATU, …)
- Pharmaco economic studies
Medical Affairs
- Medical affairs activities : shaping product strategy and successfully launching, guaranteeing quality of medical communication in accordance with scientific evidence and commercial strategy
- Post marketing studies (PASS, observational PMS)
KOLs management
- Management of Key Opinion Leaders : advisory boards, DSMB, organization of symposia, sites selection, …
Pharmacovigilance
- Medical monitoring of safety clinical data
- Review of safety reports : PSURs, DSURs, and other safety related documents
- Product safety medical review
Business Development
- Hands-on support for your partnering
- Due diligence activities
- Licensing opportunities assessment
