Monitoring - checking and ensuring that the study is conducted according to plan
Is the informative value of the study data important to you? Independent monitoring of the study is essential to demonstrate that the clinical study has been conducted in accordance with the clinical study protocol, its amendments and applicable regulatory requirements.
Have you selected appropriate study sites or are you searching for eligible sites? We support you in selecting possible sites and check their suitability and qualification for participation in the study.
The start of the study – including the first patient – is also the start of monitoring. Monitoring is planned according to the design of the study and your requirements. The complete monitoring of the study includes initiation, interim and final rounds. Interim visits do not always necessitate a 100% comparison of the source data with the data in the (e)CRF (SDV, source data verification). A cost-reducing, risk-based approach (risk-based monitoring) can and should be considered.
When the study is terminated or a study center is closed, we clarify open issues, check the completeness of the Investigator Site File (ISF) and close the center
Throughout the entire study, we act as an interface between you and the study site, thereby ensuring the quality of the study data received.
- Recruitment of potential study centers, suitability and qualification testing
- Preparation of monitoring documents such as monitoring plan, monitoring manual, documentation aids
- Setup and maintenance of ISF
- Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Close Out Visits (COV)
- Training of personnel at the study centers
- Comparison of the study data with the patient file (Source Data Verification, SDV)
- Control of (serious) adverse events and occurrences
- Monitoring report and follow-up letter after each visit
- Interface between sponsor and study centers
We provide tailored support to meet your needs, whether it is a clinical study for a declaration of conformity of a medical device or a PMCF measure in as a part of post-market surveillance (PMS).
Phone: +49 7071 98979 - 139