Data Management

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: 

• EDC/paper database design
• CRF development and instructions for investigator/monitor
• Training in EDC system and DM aspects (internal, sites, external, sponsor)
• Presentation for investigator meeting (DM aspects of study project)
• Providing status data on trial database and query process for sponsor
• Handling/import of external data (ePRO, laboratory data, images, etc.)
• Preparation for interim analysis/snapshot of data
• Medical coding (MedDRA and WHO Drug) 
• SAE reconciliation
• Medical review preparation/coordination
• Electronic data transfer in SDTM format as per FDA recommendation

All services can be offered according to bioskin^® or sponsor SOPs.