Remember paper CRFs? Just like they were digitized away, we’re streamlining out the manual steps of source data processing, putting your level of control on par with that of Electronic Data Capture.
Reliance on electronically delivered data like biomarkers, eCOA, labs, genetics, eSource, and imaging is growing. Decentralized trials are coming. Turnaround times in vendor data deliveries are often weeks, or even months, so it’s no wonder sponsors are reporting a 32% increase in end-of-study timelines.
With over 70% of clinical data now originating from outside EDC, the tsunami of "external vendor" data threatens to sink traditional data management tools and processes keeping trials afloat. To meet the demands of an ever-changing industry for our customers, we’ve expanded our platform via real-time web-based workflows for sponsors and vendors to make the process of ingesting vendor data smooth sailing.
If you create specifications in spreadsheets and transmit them via email… stop doing that. It’s time to join us in the cloud and enjoy full flexibility and control over data requirements. Our web-based specification design system guarantees that sponsors and vendors are always working in the most up-to-date specs without ever leaving the platform.
Create data transfer specs by remixing and joining elements from your global data standards and other studies using our “shopping-cart” style builder. Dealing with a file from a novel niche vendor? Use the metadata in the file to get started. All changes are tracked for posterity, including discussion threads from our Spec Chat collaboration tool.
We’ve streamlined secure file transfers from vendors to sponsor databases. As files are moved, they’re checked against your predefined structure/format, code lists, and value-level requirements.
Validation runs in-stream, generating an actionable list of any issues found, and empowering external vendors to “check their work” along the way. These live validation checks ensure high quality deliverables from the outset.
Finally, a low-friction source of analytics and metrics for objective decision making. Compare aggregate data quality among and across departments and vendors. Track turnaround times for spec development, data delivery, and issue resolution. Monitor transfer file quality and automate workflows.
Enjoy portfolio-wide reductions in effort for spec creation and study-specific programming. One client has already realized an average savings of 400 operational hours per study annually. Whether you aim to reduce edit check outputs or cut time from collection to analysis to Database Freeze, our platform is ready to transform your external vendor data management process.
Elevate specs from artifacts lost in email attachments into a centralized, living communications hub. The latest version of your spec becomes the sole location for discussing requirements and negotiating data deliveries. Chat boxes stack in the cloud version of your specs, pointed to specific cells for context.
Walk through unlimited archives to inspect granular changelogs, roll back or fork versions, and deploy or revert specific snapshots at will.