Helping you get the most out of your clinical trial

Diary/eDiary Design

Development and validation of PRO/ePRO, ObsRO/eObsRO, ClinRO/eClinRO and PerfO/ePerfO including:

  • Concept elicitation
  • Cognitive debriefing and usability testing
  • Conceptual equivalence for migration
  • Equivalence testing
  • Psychometric validation
  • FDA submissions and meeting support
  • Gap analysis
  • Mediation of licensing for standardized instruments, PRO/QoL selection
  • Digital adaptation of clinical trial protocols for hybrid and decentralized clinical trials
  • Interactive digital multimedia training (i.e., patients, caregivers, HCPs, CRAs and site raters/staff) and global translations
  • Development and validation of next generation ePRO and eObsRO using images, audio or video provided by patients/caregiveres with ratings by central experts
  • Central expert review and scoring of patient-reported data (i.e., images, audio, video)
  • Telehealth visits with central experts and live training
  • Algorithm-based monitoring for digital platforms

Over 265 ePROs developed and validated for use in global clinical trials

Over 155,000+ Patients, Caregivers, Site Raters/Staff & HCPs Trained

Training Implementation & Reporting

  • Interactive digital multimedia training
  • Learning Management System (LMS) 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 who use assistive technology to complete training
  • Training designed for traditional clinical trials, hybrid studies and fully decentralized clinical trials, product use and healthcare

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 appropriate resolution/sizing of image capture
  • Clinical central experts administer eClinROs 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

Click each icon to open the training demo

Instructor-Led Training Demo
How-To Video Demo
CC 508-Compliant Training Demo
Animated Training Demo
Placebo Effect Training Demo

Guiding you along your path to approval

Key Services

Medical Device & Digital
Therapeutics Strategy

  • Strategic Consulting and Go-to-Market Strategy
  • Project Planning & Management
  • Selecting the Right Key Opinion Leaders (KOLs): Clinical, Regulatory, Quality & Device

Medical Device & Digital Therapeutics

  • Human Factors Usability Testing and Device Validation: Observe and Cognitively Debrief Patients and HealthCare Providers on Device Use and Safety
  • FDA Meetings and Support (Pre-submission/submission)
  • Digital Product Training to Streamline Usability: Product Training for Patients and HealthCare Providers
  • Boutique CRO Services to Execute Clinical Device Validation/Pivotal Trials
  • Digital Data Capture Solutions (ePRO/eObsRO via Mobile App and eClinRO/ePerfO via EDC)
  • Demonstrating Clinical Utility to Payers and Regulators: Strategy, Submissions and Data Analysis