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 extensive experience in regulatory document preparation and 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. 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 study data management needs.
- General data management
- Data protection
- Biostatistics
Medical writing
We have a thorough understanding of regulatory requirements, and the medical writing expertise to support your documentation across your entire product lifecycle.
- Regulatory documentation
- Clinical study documentation
- Publications
Clinical evaluation
A clinical evaluation is the link between the technical file and clinical investigation. We provide services for 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.
Notice about a change in some of our email addresses
How do you shape regulatory complexity into strategic clarity?
Fast track for mononational clinical trial applications in Sweden
Upcoming webinar: what IVDR Article 5(5) means for your lab
