Protocol and Medical Writing Site and PI Feasibility Biostatistics Regulatory & Ethics Submissions Recruiting Investigator Meetings Patient & Site Rater/Staff Digital Training Central Expert Raters Telemedicine Centralized Patient Support: In-House Clinical Site ePRO, EDC, Image, Audio and Video Data Capture Safety and Reporting Remote Monitoring Data Management Logistics Management Clinical PM and Program Oversight
Diary/eDiary Design, Concept Elicitation, Cognitive Debriefing, Usability Testing, Exit Interviews and Psychometric Validation Technology Innovation Assessments and Development of Novel Digital Instruments PRO Tool Landscaping, Recommendations and Gap Analysis Digital Adaptation of Clinical Trial Protocols Clinical Trial Strategy (Target Product Profile and Clinical Development Plans Patient and Key Opinion Leader Interviews and Surveys
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
Training Translations
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Interactive digital multimedia training Learning Management System hosting capabilities Multiple application capabilities (e.g., web, mobile, SCORM, paper) Comprehension assessments, refresher training, remediation, reporting and trend analysis Training is available 24/7 Section 508 compliant digital training to enable participants, caregivers, site staff, and clinicians with disabilities to receive the same access to the training materials used by their peers*
Clinical 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 Reconciliation of primary and secondary rater scoring and consensus Data monitoring and remediation
Training can be translated into 170+ languages