Decentralized Trials

Clinical Ink is the leader in decentralized trial conduct. From our experience with an Ebola virus study of 5,000 patients in five countries in northwest Africa to our track record of successful bring your own device (BYOD) studies involving 15,000 patients across Phase I-IV+ clinical trials, we have the experience to virtualize whatever trial you present us.

Your goal may be to decrease patient visits by one, or to eliminate them completely. Through our long-time, pioneering focus on direct data capture and fully integrated patient engagement, we have built a vast toolkit of solutions, technologies, and supportive industry best practices to make your decentralized trial a reality. Seamless integration with partner technologies, such as wearables or televisits, provides an efficient, holistic solution.

Key Benefits

Make Confident Decisions, Faster

Decentralized trials allow you to improve the experience for sites, patients, and monitors while enjoying an integrated, convenient eSource solution that provides a clearer view of cleaner data at a lower cost than standard trials.

Streamline With Direct Data Capture

The Lunexis™ platform is built to capture data at the moment of inception — whether that is patient-entered data (ePRO), clinician-entered data (eCOA – ClinRos and/or Rater Scales), case report forms (CRF), or any other source. Built-in prompts and guided workflows ensure all data are correctly entered while the patient is still present, for better data quality. Eliminating transcription and validation steps saves weeks, improves the site and patient experience, decreases errors and improves data quality. Data are immediately available to remote teams and monitors for analysis, ensuring timely, regulator-approved, risk-based management (RBM).

Get Holistic Support for Televisits, Home Health, and Connected Devices and Wearables

Decentralized and hybrid studies embrace a wide variety of approaches for data collection. Clinical Ink supports these holistically. Our platform enables secure home health visits on a variety of devices. Site personnel enter data directly into our Lunexis™ eSource application while maintaining face-to-face contact with the patient. Clinical Ink can secure and synchronize devices and wearables with provisioned phones (kitting) for study use. The phones can then upload the data to a secure storage location. Our tablets, configured to reinforce the actual required workflow, are ideal for home health nurse visits. Assessments are captured directly on the tablet with no internet needed. Audio, video, photography, and patient-generated material are recorded as well. When uploaded, all data is available for immediate review and remote monitoring.

Ensure Compliance via Video eConsent

Proof of identity and video dialogue with study explanations and agreement are all recorded as the eConsent form is completed. The completed decentralized eConsent can be uploaded to the study portal for review.

Engage Patients With BYOD/ePRO

ePRO with Patient Engagement, as a unified solution, provides for a better patient experience in the clinical trial. Delivering ePRO with use of patients’ own smartphones (Bring Your Own Device – BYOD) has shown patients accessing our application twice as often and when in the application staying in it twice as long when compared to patients using provisioned devices. Improved patient experiences with patient engagement and BYOD yields real improvements in questionnaire compliance and data quality. While typical BYOD studies leverage some percent of patients on BYOD and some percent on provisioned devices – fully BYOD enabled trials tend to have significantly reduced costs and deployment timelines and can support patient enrollment in a fully virtualized model.

Get Study Drugs Delivered

Securely delivering study drugs to remote patients can pose a challenge. Traveling nurses or coordinators can do it; alternatively, clinical trial samples can be sent by registered mail with telemedicine recordings to show the sample serial number as the patient signs for it.

A Closer Look

Sponsor Perspective: Decentralized Is Reality

  • Access validated data immediately
  • Increase recruitment and retention
  • Reduce monitoring charges, improve finances
  • Enhance working partnership with sites
  • Receive automated site analytics and reporting
  • Achieve database lock within 24 hours
  • Enable decentralized and hybrid clinical trial study design

Site Perspective: Work Flows

  • Enter data once
  • Recruit and retain patients more easily using decentralized trial tools
  • Validate data at time of capture
  • Capture all eCOA data in same tool as other clinical trial data
  • Keep using familiar document-based solution
  • Interact with patients effectively
  • Additional evidence to support the conduct of the study (audio, video, etc.)

Monitor Perspective: Data Streams

  • Eliminate source data verification (SDV)
  • Focus on source document review (SDR) instead
  • Perform all SDR remotely including reviewing audio and video files
  • Focus on most important data through guided and targeted SDR
  • Register audit trail of source document effortlessly

Contact the source of better clinical trials today.

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