The Safety Management Division of CTCC has years of experience in supporting clinical trials from First-in-Human through Phase IV in many therapeutic areas.
We offer a full spectrum of safety services across all phases of clinical development (consulting, planning, and conduct) for investigator initiated trials (IIT) and industry-sponsored clinical studies (single-center / multicenter / multinational) in all indications. This comprises studies conducted under the German Drug Act (AMG) or as well as the German Medical Devices Act (MPG). A comprehensive quality management system and- a highly qualified professional team ensure highest quality standards and compliance with legal and regulatory obligations. For recording of serious adverse events (SAE), CTCC uses an established ICH-E2B(R3)-based pharmacovigilance data base that enables the management of individual case safety reports along with MedDRA coding and Eudravigilance Gateway in one central system. We ensure strict adherence to national and international regulatory requirements and guidelines, thus offering excellent prerequisites for the performance of clinical trials and for patient safety.
Our offers includes:
- Consulting service for planning and conduct of clinical trials with regard to safety management and medical monitoring
- Preparation and review of study-specific documents, including safety section of study protocol, safety manual, medical monitoring plan, and reporting forms
- Registration and maintenance of development medicinal products and substances in the EMA's XEVMPD database by registered users (also as third-party service providers)
- Serious Adverse Event management: receipt, full processing, medical evaluation, data entry in our validated safety data base, MEDRA coding, preparation of the case narrative and CIOMS reporting form
- Expedited reporting of Unexpected Serious Adverse Reactions (SUSAR) to the relevant authorities and Ethics Committees within the required time frames
- Preparation of interim safety listing and reconciliation between clinical database and safety database
- Preparation, notification and distribution of annual, periodic, and ad hoc safety reports to the relevant authorities and investigators, including, Development Safety Update Report (DSUR) concerning investigational medicinal products (AMG) as well as MEDDEV SAE report table and trimestrial SAE Summary Evaluation Report concerning investigational devices (MPG).
- Maintenance of Safety Reporting section of the Trial Master File
- Continuous safety management and medical monitoring for the entire duration of the trial: regular systematic review of all available safety information, including signal detection and risk assessment
- Provision of safety training and support for Investigators, clinical monitors, and other staff involved in the clinical studies
Team Safety Management
Lead Safety Management
Safety Physician/Medical Monitor