OC LIFe - International Clinical Trials Negotiation and Management

Senior Clinical/Regulatory Consultant supporting medical device, biologics and pharmaceutical industries. Specialized in strategic planning, project management, clinical operations, study design and implementation, new product launch.

Heike Schön, has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities in various indications. She had positions within the contract research organisations (CROs) and in the biotechnology industry. Her previous positions also included operational and general management. She holds a master’s degree in psychology and a master’s degree in business administration. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.

An accomplished Marketing and Business Development Specialist with established track record of relationship building, marketing, and business development. Driven by a passion to provide a superior and creative customer experience. Excellent communicator with strong work ethic and experience in multi-national environments with the flexibility to work in various types of organizations. Skilled at business development, strategic planning, branding, budgeting and pricing estimation with focus on providing the highest quality service.

Founder and Chief Executive Officer of Salvius Legal B.V., has a Master's Degree in Law from the University of Amsterdam and has worked in the clinical trial industry for over 25 years. During those years, she has contributed in different strategic, management and business development roles, but in particular gained extensive experience in managing the contracting process for large multi-country studies and providing further customized legal support to the different parties in the clinical trial industry. Myrthe Trompert has worked for Contract Research Organizations such as Parexel, NDDO Oncology (later INC Research, now Syneos Health) and PharmaNet (later Inventiv Health Clinical, now Syneos Health). At PharmaNet, she held the position of Sr. Legal Counsel, responsible for the regions Europe, Latin- America and Asia. Since 2010, she is CEO of Salvius Legal and made it her mission to assist the different stakeholders in the clinical trial industry to make the contracting part of a clinical trial a manageable and controllable process, by applying efficiencies and creative solutions to improve timelines, while maintaining quality and consistency of the contracts involved.