Expertise.
Clinical and Medical Affairs.
Our expertise in clinical and medical affairs offers you comprehensive support in study management, risk assessment and market surveillance.
Well thought out?
Are your study concepts aligned with the relevant regulatory and medical requirements?
Reliable?
Have you implemented processes to record clinical data accurately and efficiently?
Secure?
Do you ensure that all safety and monitoring obligations are fulfilled?
Discover our Clinical & Medical Affairs portfolio.
With our Clinical & Medical Affairs services, we provide you with comprehensive support in the planning, implementation and follow-up of clinical projects and the fulfillment of medical and regulatory requirements.
QPPV (Qualified Person for Pharmacovigilance)
Use our QPPV services to ensure drug safety and regulatory compliance.
Signal Detection
Ensure the quality and safety of your clinical trials with precise signal detection and timely risk assessment.
Clinical Monitoring
Ensure compliance with GCP standards and data integrity in your clinical trials.
CRO Support
Optimize your collaboration with CROs and ensure the success of your clinical trials.
Post Market Surveillance
Ensure the quality and compliance of your products through effective post-market surveillance.
Clinical Project Management
Efficient planning, implementation and follow-up of your clinical trials in the life science industry.
Medical Writing
Creation of precise, compliant and well-structured documentation for the pharmaceutical, biotech, medical technology and IVD industries.
Clinical Affairs
We support you in the precise planning, regulatory-compliant execution and successful completion of clinical trials.
Medical Device Vigilance
Comply with regulatory requirements and monitor your products for potential risks.
Pharmacovigilance
We support you in comprehensively monitoring the safety of your medicinal products and meeting all regulatory requirements.
GCP (Clinical Trial).
Optimise your clinical quality system with our Life Science Consultants.
Clinical evaluation (MDR / MEDDEV)
Ensure the safety and performance of your medical devices through sound clinical evaluation.
Post-Market Clinical Follow-up (PMCF)
Comply with MDR requirements, collect reliable data and ensure the efficacy of your products in the long term.
