Clinical Affairs deals with questions relating to the clinical application of a medical device or pharmaceutical product. The aim of the activities is to prove that the products actually provide the clinical benefit in practical use that is set against the risk in risk management. The clinical benefit of the product must be supported by data and monitored and confirmed throughout the product life cycle.
With our personnel and expert solutions, we help solve resource bottlenecks to the point. With flexible experts on a temporary basis – or selected permanent employees who become part of the team structure at the customer’s site.
The MDR and the AMG tighten the requirements for clinical evaluations. We offer the customer immediate expert support – also dovetailed with the additional areas of risk management, quality management and post-market surveillance (PMS).
Our service areas for fixed and flexible resource solutions:
- Development of a Clinical Strategy Plan (CSP)
- Creation of standard operating procedures (SOP) for uniform project implementation
- Test plan development and statistics planning
- Know-how in all regulatory requirements (ICH-GCP, ISO 14155, AMG, AMWHV, MPG, MDR, MDD (93/42/EEC), MEDDEV documents)
- Cost planning and project management
- Study design and recruitment of study participants
- Global study execution and monitoring (documentation, execution, follow-up, local regulation)
- Literature research and market monitoring
- Preparation of study documents (protocol, eCRFs, patient information, investigator folders).
- Market Monitoring and Post-Market Surveillance (PMS)