Laboratory Data Management Program Boosts Productivity Scores Big On Customer Satisfaction

A major biotechnology firm asked INC Research/inVentiv Health to help reengineer laboratory data management activities to enhance productivity.

The sponsor wanted to ensure the accuracy and integrity of all data while streamlining operations.

To achieve the client’s objectives, INC Research/inVentiv Health instituted strict data entry and review guidelines to ensure a uniformly high level of service and rapid turnaround of data, and implemented processes for client data review, including:

• Expedited entry of laboratory reference ranges into Oracle™ Clinical or MediData Rave™ database with 100% inspection to ensure accuracy and compliance with standards
• Tracking turnaround times and completion of each entry in a Study and Issues Log to spotlight project execution issues for resolution by the client
• Reviewing data listings to identify omissions, out-of-range values, and updates required before assigning specific labs to sites and subjects
• Entering anomalous findings into the database and prioritizing them for review by the client
• Creating manual queries pertaining to the laboratory data, which are then reviewed by a senior reviewer and issued by the staff
• Conducting weekly joint meetings to review the progress of studies and metrics.
• Screening lab manager candidates based on the client’s criteria, and then trained those selected on proper data management systems, client SOPs, and specific handling conventions.