Executive/expert dedicated to the development and regulatory approval of innovative therapeutics.
Supports bio-pharmaceutical companies in their general and clinical development to ensure financial and scientific optimizations, while warrants regulatory compliance.
With more than 25 years of experience into contract research organizations (CROs), as consultant, operational, executive director and CEO, has accumulated a wide experience at different levels, such as:
-- Clinical Trial project management (e.g. scientific, biometrics and compliance coordination). Clinical package leader for two FP7 (now Horizon 2020).
-- Set-up of operational departments and their management (e.g. project and external expert management, clinical operations, biometrics, imaging, clinical operation IT, submissions and archiving).
-- Company management (e.g. strategy, relation with banks, institutional investors, M&A, subventions, human resources, corporate facilities and IT, purchasing/subcontracting policies).
-- Quality assurance and regulatory intelligence.
Expertise domains (initial training in biology):
-- Regulatory compliance (scientific, CTA, GxP processes/tools (EDC), relations with Competent Authorities, submissions (eCTD/CDISC)).
-- Statistics (trial design, adaptive design, analysis plan and execution, SAS and R programming).
-- Clinical Data Management and other processes such as logistics, randomization, imaging.
-- Clinical IT project management
Citation/acknowledgements: “Special thanks also go to Antoine Périer and his team at Cardinal Systems, Paris, who fully supported this innovative study from inception to completion and largely contributed to its success.”
In https://www.crcpress.com/product/isbn/9781482239881 chapter 21 “A Single Pivotal Adaptive Trial in Infants with Proliferating Hemangioma: Rationale, Design Challenges, Experience and Recommendations”
Publications: https://www.researchgate.net/profile/Antoine_Perier2/contributions
Consultant @ Advice for Biotech, Pharma, Medtech, Diagnostic, and Alimentary Complement Companies
Regulatory Strategy & Compliance, Clinical Development, Project Management From June 2015 to Present (7 months)
Antoine PERIER is skilled in: Clinical Development, CRO, Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Research, CTMS, Life Sciences, Lifesciences, EDC, ICH-GCP, Biostatistics, Data Management, CDISC, Medical Imaging