Companies running regulated systems such as Oracle® AERS and Oracle Clinical are required by international regulatory requirements, including CFR 21 Part 11, to ensure access to all clinical, safety and related data at any time. Complying with these regulations is expensive, time consuming and technically challenging, forcing many companies into non-compliance by deferring the implementation of a business continuity plan.

Our consultants can assist companies in developing and executing a Business Continuity Plan, including backup/recovery and disaster recovery, and covering both the computerized systems and corresponding standard operating procedures.

Additionally, we can provide data archival services for Oracle AERS which includes the collection, storage and testing of the archived data on a regular basis. An entire database can be archived or data can be archived based on any selected criteria such as by product, project or study.