Monitoring and Study Assistance
Accurate, reliable, competent
The monitoring activities of our experienced experts during study conduct equal a kind of “quality safety net” intended to support you in achieving high-quality results.
- Monitoring of indication-related study parameters according to protocol, trial monitoring plan, etc.
- Verification of compliance with regulatory requirements (Medicinal Products Act – AMG, Medical Devices Act – MPG, GCP, etc.)
- Key contact person for study team and sponsor
Depending on the individual project requirements concerning the monitoring strategy, we can offer you different approaches.
- On-site visits performed by our clinical monitors / CRAs
- Focus on informed consent forms / data protection, SDV – Source Data Verification
- Risk-based approach – focus on critical data and processes
- Systematic and timely data analysis of eCRF data or data from other electronic systems
- Review by clinical monitors / CRAs, data managers, statisticians
- Medical and coding review
- Telephone monitoring / video conferencing
- Focus on SDR – Source Data Review / check of plausibility and completeness of eCRF data or data from other electronic systems
Based on ICH-GCP (E6) R2, we offer targeted site coaching in order to minimize risks. This can be achieved by preventively providing support and guidance from our experienced employees to the site. Thus, potential sources of errors can already be eliminated in advance or can be solved directly upon occurrence.
This service can be made use of at any time of the project, whether at the start of recruitment or at a later stage. Of course, a combination with classic monitoring is also possible.
Our proven risk-based site coaching includes the following services, which can be carried out either directly on site or even remotely:
- Recruitment support
- Assistance with first sampling or shipping activities
- Support during first data entries in the (e)CRF
- Speed GCP-Trainings
- Ongoing target-actual analysis of project-critical processes
- And many more
Our study assistants – also called flying study nurses – will strengthen the study team at site and will ease their workload accordingly. Due to their flexibility, optimised support can be provided to the local study teams in form of an efficient and professional co-operation.
We would also be happy to assist you in defining and developing the monitoring strategy for your project.