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
