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Clinical
Outcomes
Optimization

Helping you get the most
out of your clinical trial.

Contact Us

We are a full-service boutique CRO with over 17 years of experience, having conducted more than 250 clinical trials with more than 35,000 participants

  • 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

ePRO Development & Clinical Strategy


  • 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

PATIENT, CAREGIVER, SITE RATER, HCP & CRA DIGITAL INTERACTIVE TRAINING

Click here for an overview of our training capabilities

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


Training Translations

  • Training can be translated into 170+ languages
  • Supports global deployment

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Training Implementation & Reporting

  • 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*


*Section 508 is an amendment to the Rehabilitation Act of 1973 which prohibits discrimination on the basis of disability. SPRIM’s digital training has closed captioning for the hearing impaired, as well as alternative text to describe images relevant to training and sequencing for those who are visually impaired and use screen readers and/or their keyboard to complete training.

CENTRAL SCORING OF PATIENT DATA

  • 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

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