Clinical investigation project management
We work together with you and lead the clinical investigation project efficiently to save you time and resources. Our CRO team with experienced project managers, monitors, medical writers, data managers and medical advisors work closely with you to ensure the project's success.
Regulatory submissions
We have practical knowledge of the often complex local and EU regulations and requirements for clinical investigations. Whatever the regulatory purpose of a clinical investigation we ensure compliance and consistent communication with the ethical committees and regulatory bodies, and have a strong experience in regulatory document preparation. We ensure that the crucial safety reporting of a clinical investigation is performed according to requirements.
Data Management
We are your one-stop shop for all clinical investigation data management needs.
- General data management
- Data protection
- Biostatistics
Medical writing
We have experience in merging data and regulatory requirements into compliant documentation across the entire lifecycle of the device.
- Regulatory documents for clinical investigations
- Publications
Clinical Evaluation
A clinical evaluation is the link between the technical file and clinical investigation. We provide services in the planning, preparation and conduct of clinical evaluations.
Clinical investigation
Our offering covers planning, development, conduct and reporting of medical device clinical investigations in accordance with the ISO 14155:2020 standard and considering MDR and national requirements.
Introducing Aurevia
New EQA schemes for 2025
Patient Safety: The Cornerstone of Healthcare
EQA Program 2025
