EHR to EDC

Data flows from EHR to MyLinks then to ResearchLink with patient consent

  • 21st Century Cures Act requires all EHRs and health organizations to give patients immediate access to their data via FHIR applications (MyLinks) at no cost. Patients are then free to share their data with whomever they wish (ResearchLink). This removes the need for lengthy data requests and contracts with health organizations. FHIR also provides valuable metadata elements to verify mapping accuracy and provenance.

  • Research team views the data in near real time within ResearchLink, and with two clicks sends the data into the EDC.

  • All data has provenance with all actions logged, 21 CFR Part 11 and HIPAA compliant.

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Smart Alerts

  • Automated Alerts to notify research team if values are out of expected ranges.

  • Patients can click on a drug reaction list within MyLinks to notify research team of an event.

  • Patients can complete a more comprehensive form for serious adverse events.

Adverse Events, PROS, and Secure Communication

Gather insightful data from patients as they progress through a clinical trial.

  • Give your patients the ability to submit adverse events.  Once received, you’ll be able to add necessary information and push it to the next step with ease.

  • Automated collection of PROs (Patient Reported Outcomes) PRO and other data collection forms are presented to the patient at designated time intervals. The data flows into ResearchLink and the team is notified of new data.

  • Securely communicate with patients using the ResearchLink platform.

eConsents

Patients complete eConsent forms, with the final form saved in their MyLinks user account.  All eConsent signatures are 21 CFR Part 11 compliant.  Features include:

  • Signature-level credentialing

  • Signature-level meaning (signing reason)

  • Signature manifestation (printed name, date/time and signing reason)

Discover The Future

We are a multi-disciplinary laboratory committed to focussed and efficient drug discovery.