Helping you navigate confidently and smoothly through trials

Boutique CRO

Full-service boutique CRO with over 17 years of experience-conducted more than 275 clinical trials with more than 40,000 participants

  • Decentralized and hybrid clinical trial consultation, design and strategy
  • Digital adaptation of Clinical Trial Protocols
  • End-to-End CRO solution for clinical trials (decentralized, hybrid, site-based)
    • Protocol and study document preparation
    • Site feasibility and selection
    • Biostatistical services
    • Regulatory/Ethics submissions
    • Digital recruitment
    • Digital training for patients, caregivers and site raters
    • Diary/eDiary design
    • PRO/ePRO and ObsRO/eObsRO instrument development and validation
    • Digital data capture using a mobile app for consumers/patients (ePRO), caregivers (eObsRO) and for site raters and staff EDC (eClinRO and ePerfO)
    • Innovations (DIY vitals, biosampling, wearables, biosensors)
    • Next Generation ePRO: Patient/Caregiver capture of images, audio and video, and central expert ratings
    • Investigator meetings
    • Data management
  • Remote patient monitoring
  • Safety/reporting
  • Medical writing
  • Logistics management
  • Telehealth visits and central expert raters
  • Provision of clinical project managers and/or clinical research associates for trials
  • Executive and Program oversight
  • Medical writing and publication

Years as Boutique CRO

Clinical Trials Completed

Clinical Trial Participants

Experienced in all phases of clinical trials (interventional, observational, phase 1-4)

Decentralized clinical trial optimization for greater adherence, compliance, and retention

Experienced across therapeutic areas including:

  • Cardiology
  • CNS
  • Dermatology
  • Gastrointestinal
  • Hepatology
  • Immunology
  • Infant Nutrition
  • Infectious Disease
  • Nephrology
  • Nutrition
  • Oncology
  • Pediatric Ophthalmology
  • Oral Health
  • Rheumatology
  • Sleep
  • Women’s Health


Biopharmaceutical & Biotechnology
Medical & Digital Devices
Consumer Health

We are a global CRO with offices in the United States (Boston, New York, Orlando), Australia, Brazil, Mexico, Singapore, and Europe

  • 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
    • Psychometric validation
    • FDA submissions and meeting support
    • Interactive digital multimedia training (i.e., patients, caregivers, HCPs, CRAs and site raters/staff) and translations
    • Development and validation of next generation ePRO and eObSRO using images, audio or video provided by patients/caregivers with ratings by a central expert
    • Central expert review and scoring of patient-reported data (ie, images, audio, video)
    • Telehealth visits with central experts and live training
    • Algorithm-based monitoring for digital platforms
    • Medical marketing strategy
    • Patient support programs
    • HCP engagement programs
    • Qualitative research (interviews/focus groups)
    • Quantitative research (digital surveys and questionnaires)
    • KOL identification and interviews
    • FMCG product quality control

    Accelerating your path to approval in infant nutrition

    SPRIM has conducted:

    14 Infant Nutrition Clinical Trials

    Including site-based, hybrid and decentralized clinical trials (DCTs)

    FDA Approval

    SPRIM received FDA approval for the first fully decentralized infant growth and tolerability study

    5 Strategic Projects

    Directed at infant nutrition market, regulatory and compliance analysis

    Key Services

    Infant Nutrition Strategic Services

    • Strategic Consulting and Go-to-Market Strategy
    • Gap Analysis (Clinical, Regulatory, Quality)
    • Identification, Selection, and Interviews with Key Opinion Leaders (KOLs)
    • Ingredient and Country Landscaping
    • Formulation Review
    • Qualitative Research (Interviews/Focus Groups)
    • Quantitative Research (Digital Surveys and Questionnaires)

    Infant Nutrition Regulation

    • Regulatory, Strategic and Compliance Recommendations
    • FDA Support and Meetings