The Need
A leading global life sciences company, Top 5 Global CRO Company, provides contract research and developmental services to the pharmaceutical, medical technology, crop protection, and chemical industries.
The current requisition process contains many delay points due to manual processes or outdated system design deficiencies in both the requisition design and the accession submission processes. The primary need for this project was to digitally transform the specimen collection data gathering process, thereby improving the entire clinical and business process.
The Challenge
The Clinical Laboratory Standards System (CLS) requires investigator sites to use pre-printed requisitions generated from the Study Definition web application to record critical information about the patient and sample during specimen collection. These requisitions are shipped with the samples to a central lab where they are imaged and hand-keyed into another system, potentially leading to numerous errors and site queries that delay result delivery to investigator sites and sponsors.
The biggest challenge of the current project is to provide a smooth and continuous electronic communication process between the existing client systems, replacing the paper requisitions with digital ones.
Тhe Solution
The project creates an electronic solution for both defining and submitting requisition information. It leverages the existing Study Definition application to create complex kit definitions and enables our client to make changes to the requisition form instantly. The submission process is designed for eRequisition to send the site data directly to the processing system, eliminating manual steps and delays in hold generation, where applicable.
In compliance with FDA 21 CFR Part 11 and GMP, this solution guarantees the highest product quality.
The digital solution delivered by BGO Software in the first phase of the project achieves the following deliverables:
- Replace paper requisitions with new, protocol-specific eRequisitions
- Establish auto-eReq generation based on Study Definition input parameters
- Create online specimen collection instructions
- Create new business processes and system workflows to support eReq in LPS (Laboratory Preanalytical Services), Investigator Support, and Desktop Publishing
- eReq versioning capability and “real-time” access to the latest requisitions
- Unified Requisition Viewer
- Integrate with Study Definition to obtain data necessary to create the eReq
- Integrate with the central processing system to manage incoming eReqs
Value Delivered
This project establishes a modernized approach to defining requisition forms and accepting requisition data. eRequisition automates many currently manual processes, speeding up the requisition creation process. Electronic entry eliminates the need for a team dedicated to the double entry of handwritten information.
The greatest value that the clinical data entry system brings is the transition from a paper-based process to fully digitized operations, positioning the client strongly among competitors and benefiting the entire process and medical staff involved by:
- Increased protocol compliance
- Sample awareness
- Data digitalization
- Improved result turnaround/decreased data reconciliation
- Decreased data revisions
- Elimination of manual data entry
- Enabling batch processing of samples
- Elimination of requisition imaging
- Enabling specimen tracking and staff planning efforts
- Reduction in internal manual hold tracking efforts
- Cleaner/”Ready Now” data to facilitate timely data locks/decision-making
