About Pierre

Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information System. 

Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner representing the Industry & Academia since 2019, continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimization.