bioskin® uses validated, robust systems for in-house data management which allow for tailoring of individual databases to meet the client’s requirements. We offer paper-based data collection as well as EDC (Electronic Data Capture) and ePRO (electronic Patient Reported Outcomes). Flexibility of our processes allows us to maintain data quality while adhering to timelines, even in the face of changes to data collection specifications during an ongoing trial. Our data management processes are compliant with ICH GCP and 21 CFR Part 11.
Data management services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:
All services can be offered according to bioskin® or sponsor SOPs.