ProofPilot, the digital protocol automation platform for clinical trials, and Human API, the industry-leading platform enabling life sciences organizations to connect and convert consumer health data into actionable health intelligence, today announced a collaboration that will allow researchers to digitally access consenting participants’ electronic medical records (EMRs) through the ProofPilot platform. This partnership will provide a much-needed solution for the highly-complex research industry to improve recruitment and remotely monitor clinical trial data in a more productive and cost-effective way.
The integration between ProofPilot and Human API allows participants to remotely opt into a process to locate, authenticate, and provide access to the EMRs from their original HCP or the study site in a secure, compliant manner through the convenience of their mobile device, enabling two novel capabilities in recruitment and monitoring. For recruitment, clinical site staff can now more thoroughly pre-screen patients in an evidence-based way, prior to the formal screening visit, to vastly improve the screen-fail ratio and reduce the wasted efforts and time of patients and staff when the study is not a good fit.
Additionally, clinical research monitors (CRAs) can remotely monitor the source documents of a clinical trial side-by-side with the study data on demand, eliminating costly travel and other non-value-added activities.
“Evaluation of prospective patients in research that don’t end up qualifying is a huge pain point for sites and patients in both time and cost. Meanwhile, clinical monitoring remains by far the biggest line item in the research budget,” said Joseph Kim, Chief Strategy Officer at ProofPilot. “With Human API’s approach to digitally allow participants to provide access to electronic medical records, our platform can help to greatly improve two of the biggest problems in research conduct today.”
Source Document Verification (SDV) remains the most costly component of a clinical trial, due to costs for site visits and downtime of CRA travel. Thus far, most Remote Source Document Verification (rSDV) solutions focus on burdensome document uploads or difficult third-party access to local EMR systems. ProofPilot’s partnership with Human API will finally create a path for life science sponsors to reduce or eliminate costs for SDV by offering a comprehensive set of capabilities to perform rSDV.
Patients will also benefit as the burden normally required to collate this information on their own will disappear. Additionally, having accurate medical records on hand by the study staff decreases the likelihood of any safety issues attributable to missing or forgotten details about medical history or drugs currently being prescribed.
“Human API is committed to being the leading platform to engage patients and facilitate the connection, conversion, and sharing of consented health data for clinical trials, patient registries, and patient support programs,” said Christian Wieland, Chief Product Officer from Human API. “We’re thrilled to be partnering with ProofPilot for this important work, which will play a key role in advancing clinical research for life sciences organizations, ultimately enabling potentially life-saving interventions to get to market faster.”