Clinical Outcomes Optimization

Helping you get the most out of your clinical trial.

ePRO Development & Validation

  • Diary/eDiary Design, PRO/ePRO and ClinRO/eCLINRO Development and Validation including: Concept Elicitation, Cognitive Debriefing, Usability Testing, Exit Interviews, Psychometric Validation, Briefing Book/Dossier Preparation, FDA Meetings and Regulatory Support

  • Mediation of Licensing for Standardized Instruments, PRO/QoL Selection and Gap Analysis

  • Technology Innovation Assessments (wearables, biosensors) and Development of Novel Digital Instruments

  • Digital Adaptation of Clinical Trial Protocols

Experienced: Over 260 ePRO developed and validated for use in global clinical trials

Patient, Caregiver, Site Rater, HCP & CRA Digital Interactive Training

Over 150,000+ Patients, Caregivers, Site Raters/Staff & HCP Trained

Training Implementation & Reporting

  • Interactive digital multimedia training
  • Learning Management System hosting and within app capabilities
  • Multiple application capabilities (e.g., web, mobile, SCORM, paper)
  • Comprehension assessments, pre-qualification, refresher training, rater remediation, reporting and trend analysis
  • Training is available on demand 24/7
  • Printable certifications for site raters
  • Section 508 compliant, closed captioning for the hearing impaired, alternative text/sequencing for the visually impaired and can use assistive technology to complete training
  • Training designed for traditional clinical trials, hybrid studies and fully decentralized clinical trials
Training Translations
  • Training can be translated into 170+ languages
  • Supports global deployment
Training Topics
  • Roles and responsibilities, expectation setting and study overview
  • Minimizing placebo effect
  • Accuracy in reporting on PRO/ePRO, ClinRO/eClinRO, ObsRO/eObsRO and PerfO/ePerfO duration, severity and frequency including definitions and terminology
  • Importance of compliance with study tasks and procedures and medication/product adherence
  • “How-to” video-based tutorials for demonstrable procedures and tasks, such as using wearables, biosensors, DIY kits, collecting biological specimens and medication/product use
  • Study workflow and use of technology (i.e., devices, medical devices, software, mobile apps, systems integration)
  • Reporting on potential AE/SAE, concomitant and prohibited medications or products
  • Tracking shipments and receiving incentives

Central Scoring Of Patient Data

  • Clinical central experts rate image, audio and video files in a blinded manner for clinical trials, improving the quality of patient and caregiver reported outcomes
  • Technology enables PHI scrubbing and resolution/sizing for image capture
  • Clinical central experts administer eCLINRO’s via telehealth visits
  • Clinical central experts can observe and train patients and caregivers on how to conduct a procedure at home
  • Reconciliation of primary and secondary rater scoring and consensus
  • Data monitoring and remediation

Training Demos

Clinical Outcomes Optimization

Helping you get the most out of your clinical trail.