HCTC was founded in 2005 and is an academic Contract Research Organization (CRO) dedicated to provide clinical trial management services and early product development support. HCTC combines the clinical expertise and academic leadership of a premier German teaching hospital with the full-service operational capabilities of a contract research organisation (including project management, regulatory affairs, clinical monitoring, data management). The majority shareholder of HCTC GmbH is Hannover Medical School (MHH), a leading German Academic Medical Centre. Special fields of expertise of HCTC are studies involving Advanced Therapy Medicinal Products (gene and cell therapy), medical devices, paediatric studies, and studies in the field of nephrology, liver diseases, and oncology. HCTC has established a clinical research network within multiple teaching hospitals of Hannover Medical School enabling efficient patient recruitment in a broad range of clinical indications. According to ICH standards, an E2B compliant electronic reporting system has been established enabling pharmacovigilance services including electronic reporting to national authorities of most countries of the European Union.

 

Role within the project

  • BIO-RAID representation in Germany, Romania and Moldavia (and potentially other countries);

  • Clinical trial set-up and management in Germany, Romania and Moldavia: regulatory affairs (submission to respective ethics committees, interaction with competent authority to clarify status of trial), provision of insurance (if applicable), quality assurance (selected monitoring visits);

  • General support of study management.

 

Description of key people involved in the project