clinical research services

• Specialization in oncology, broad experience in clinical trials with biopharmaceuticals, biosimilars, full human antibodies and small molecules
• Planning, execution, management of phase I-III clinical studies, trial monitoring and international project management
• Supervision, leading, management and development of the clinical field operations team
• Capacity planning, resource management, supervision, issues management for all clinical sites and all CROs
• Selection of participating sites, investigator identification, investigator meetings, protocol finalization
• Preparation and submission of all relevant study documents to authorities (Ethic Committee, BfArM, radiation protection authority) and resolution of follow-up questions
• On-site and in-house clinical data monitoring, data review and management with constant study progress reporting
• Consultation and guidance through every step of the clinical development process, from small studies to complex, multinational projects

Thomas works in adherence to all agreed timelines in compliance with regulatory and legal regulations and policies, ICH/GCP regulations and guidelines, including assurance of complete HIPAA compliance of any clinical program.