xCures is patient-centric: We support patients in their care journey with real-time access to their medical records and organize their data to support clinical decisions.
The clinical, genomics, and imaging data that we gather and structure from all different sources (providers, sites, EMRs, etc.) supports outcomes assessments, decentralized clinical research, and real-time identification of patient cohorts.
Real-time, Regulatory-grade Clinical data
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Our Suite of Solutions
xUTILITY – Real-time Clinical Data
xCures collects real-time clinical, genomics, and imaging data directly from all sites of care. Through this, xCures has built a library of disease and drug-specific registries. Complete, licensable, 360°-view patient cohorts with data from diagnosis to final outcome.
xCures’ ability to recruit patients directly and to automatically retrieve and structure their medical records expedites screening against I/E criteria and delivery of fit-for-purpose regulatory grade data sets.
Our “Last Mile” program reaches out to eligible patients and supports navigating the final steps of enrollment into clinical programs.
xCures’ timesaving Expanded Access services include study protocol writing, site startup support, patient screening, and data collection. Real-time, regulatory grade outcomes data is collected in our Part 11-compliant EDC system. Data is collected without burdening clinical sites and/or site staff.
xCures’ automated data structuring makes transferring data from the EHRs across sites of care into the Case Report forms in the EDC system easy. xCures can follow the patient from all care sites, allowing for a seamless solution for continuous evidence generation. An integrated toolset further enables accurate, source-verified long-term survival assessments without burdening patients, providers, or sites.
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MORE CASE STUDIES
Prospective, Longitudinal QoL Study
Business Need
A sponsor with an approved product for Glioblastoma Multiforme (GBM) sought quality-of-life (QoL) data and how specific treatment regimens and biomarkers affected patient QoL over time.
Solution
For over a year, xCures collected weekly EQ-5D QoL surveys from GBM patients across the United States (n > 800). That data was linked with our clinicogenomic and outcomes data for those patients structured directly from their longitudinal medical records.
Results
Sponsor has identified specific cohorts impacting patient QoL on the sponsor’s GBM asset. The findings were published as an abstract at SNO 2022, and a more in-depth publication is planned for 2023
Decentralized Nationwide Trial
Business Need
A small biotech with a site-based trial had difficulty enrolling patients at 9 large sites. Their number one priority was to increase the pace of enrollment.
Solution
We opened a decentralized nationwide “site” and partnered with a DCT vendor for remote PI and at-home administration and monitoring. We established an EHR-2-EDC process with Source Data Verification and started direct-to-patient recruitment on social media.
Results
We enrolled the first patient within two weeks of opening the decentralized site, and within the 1st month, xCures had screened more patients than all sites combined.
Expanded Access Basket Trial
Business Need
A sponsor wished to offer compassionate access to their therapy for patients who could benefit. This also enabled them to assess their product's efficacy and safety in various tumors and product combinations to prioritize new indications, identify efficacious combination regimens, and accelerate clinical development of the primary indication.
Solution
xCures opened a real-world basket study in the compassionate use setting with an intermediate expanded access protocol. xCures holds the IND, manages all physician and patient inquiries, collects and structures all the data, and works with the sponsor to ensure all annual, expedited, and cross-IND adverse events are reported. Combinations with approved therapies are allowed at the treating physician’s discretion and approval by the sponsor and xCures.
Results
Eighty-seven patients have been treated at 30 sites. Data from the EAP has seeded a new phase 2 combination trial. There have been several complete responses, including one detailed in a case report published in Melanoma Research (Aug 2022)
Expanded Access Program in DMG/DIPG
Business Need
A sponsor had recruited 172 patients in 6+ years with a site-based approach and needed to accelerate the pace of enrollment to speed up the time to data maturity.
Solution
xCures set up an expanded access program in DMG, in partnership with non-profit organizations, and managed inbound physician requests. We opened the protocol at 40+ sites and built a network of GBM/DMG/DIPG oncologists. Regulatory-grade data was collected via the EHR-2-EDC process.
Results
Over 18 months, xCures enabled pre-approval access for 132 patients ineligible for clinical trials. xCures collected over 120,000 data elements and provided a custom dashboard of graphs and tables. The integrated analysis submission for NDA included 20% of EAP clinical data and 50% of safety data.
“xCures has been a valuable partner for Endeavor. They are a pleasure to work with and take great care in finding just the right trial for each patient.”
