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Accelerate the consented use of bio specimens in secondary research quickly and easily through digital process automation (DPA)
Virtusa's electronic Patient Informed Consent (ePIC) solution harnesses digital technologies such as DPA, AI, NLP, and data analytics to ensure broad access to valid patient consent records. It streamlines and automates the collection of patient consents across various clinical trial operations systems to enable a powerful, automated process for matching secondary research targeted samples with their respective consents. It precisely matches bio sample data with the patient's electronic signature, and shares the consent form electronically across all stakeholders.
How does it work?
Our approach is based on state-of-the-art DPA technology that allows organizations to store a great deal of related information across business processes and seamlessly access them, creating a containerized process. Researchers, study managers, and regulatory compliance professionals can manage and collaborate on complex processes without depending on email, spreadsheets, or paper, to organize data. The Virtusa ePIC case-based system starts by treating each study as a parent case, with the ability to rapidly and traceably spawn sub-cases for different study sites or sample types.
The ePIC system provides a researcher with the ability to issue a search query for samples, or even be provided a data extract from internal systems that forms the basis of their search. The case management software "wrapper" automates the process of locating the appropriate consent approval, and can group studies by consent status. Persistence is maintained until the case is resolved by the ethics manager, indicating that the researcher may use the sample for its new intended purpose.
A leading global pharmaceutical company was struggling to keep up with the need to verify informed consent for secondary research due to manual and inefficient processes.
Validating proper consent for existing bio samples in their various CTMS databases was difficult to determine and impacted the ability to initiate new research. In this legacy approach, once target samples were identified, the sample IDs were transferred to Excel for manual tracking and approvals.
They would examine consent forms using patient IDs to refer to the source document repository. Once consent was confirmed, the research team would then engage the ethics team for validation and approval. The process to obtain a sufficient quantity of authorized samples to start the research process could take months.
Virtusa implemented the case-based ePIC digital process automation application and integrated the system into the company’s various CTMS databases to source initial sample targets.
Once a target list of representative samples is identified, ePIC automatically queries the content repository mapping the patient ID to archived consent forms. The document-based forms are then processed by applying artificial intelligence and natural language processing algorithms to extract the consent purpose and level within the documents.
High probability records are shared with the R&D coordinator to validate intent. After pairing with the designated sample targets, the combination of sample ID and patient consent are then shared with the ethics team for final validation.
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