Coordinate investigator initiated research
Conducting investigator initiated research with medicines is complex and the administrative burden is high. To perform clinical research in compliance with law and regulations all research staff should be trained and qualified.
Penthecilia support the conduct of your study, take over project management and design CRF’s and write SOP’s. Furthermore Penthecilia can monitor your study and perform source data verification. Click here for information about monitoring.
Beside that we can train all your research professionals in ICH-GCP en implement these guidelines in daily research practice. Click here for information about GCP training.
Our services include:
- Perform project management
- Design CRF’s
- Design study site files (e.g. investigator site file)
- Support the application process to IRB
- Write SOP’s for the site
- Perform data management
- Support study administration
- Monitor the study procedures and data