The current and prevalent methods used by pharmaceutical companies to conduct biological specimen analysis are manual, cumbersome, and inadequate. Activities such as protocol documentation, appointment management, sample collection, and consent management are done using spreadsheets, legacy systems, and emails. Pharmaceutical companies are looking for ways to streamline the end-to-end sample collection and management process.
With Virtusa’s Sample Collection, Orchestration and Reconciliation (SCORE) solution, companies can seamlessly digitize the end-to-end sample collection process to improve clinical trial efficiency.
The biosample collection process has become more complex with the advent of precision medicine and focused biomarker analysis. In the absence of a comprehensive workflow management capability, companies rely upon legacy systems to manage the entire process. The protocol is manually transcribed, and collaboration is through emails. Subject appointments are managed through visit files, and sample collection is often inadequate. These factors mean that any amendment in the protocol document results in confusion in downstream processes and inconsistencies in sample data, uncategorized donor consent, and sub-optimal clinical research outcomes.
To address these common barriers, Virtusa’s SCORE enables automated reconciliation, monitoring, and reuse of biosample data. The solution uses digital process automation (DPA) and has in-depth detailed workflows that meet and exceed Good Clinical Practice (GCP) standards.
SCORE has several modular layers that streamline end-to-end sample collection processes, enhancing the biosample research process all the way from the time of collection to its usage in bioanalysis and medical research. The solution uses advanced visualizations to show sample tracking, making it easy for laboratories to file, label, and analyze various biosamples.
Virtusa’s SCORE uses a framework that focuses on the early stages of a trial. These stages include: digitizing protocol documents, creating logistic plans, ensuring sample collection according to the plan, registering, identifying, and linking samples, enabling secondary use, integrating with clinical operations, and assay data management systems.
Six modular layers, Plan, Ingest, Decide, Consent, Resolve, and Core, form SCORE's key features:
- SCORE Plan is a digital process automation (DPA) based solution for capturing and processing biosample collection plans.
- SCORE Ingest is a flat-file data upload, transformation, mapping, and translation solution to allow data submissions from external sources.
- SCORE Decide is a highly configurable business rules design, and execution component. It allows the execution of custom rules on transmitted as well as stored biosample data, and other upstream information.
- SCORE Consent is a DPA-based solution that provides the link between patient informed consent templates and secondary use requests.
- SCORE Resolve is a DPA-based solution for handling violations of business rules such as failed sample data quality checks and collection plan deviations.
- SCORE Core is a centralized component that stores biosample lineage and identification, immutable biosample properties, and biosample events.
Efficient sample collection with a 30% reduction in manual effort and improved compliance
Our solution creates a seamless end-to-end collection process with enhanced automation for improved sample tracking, reduced costs, increased biosample reuse, and faster research requests. Biosample data collection is digitized and automatically categorized for easily accessible sample reports and status updates. Trial samples and research efforts are optimized with a common sample registry with the use of prescriptive and predictive analytics.
Key solution benefits include:
- Increased efficiency
- Reduced costs and improved study protocol execution
- Improved compliance
- Automated and accurate reconciliation