BOUTIQUE CRO:
CLINICAL TRIALS & DCTs
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
- COVID
- Dermatology
- Gastrointestinal
- Hepatology
- Immunology
- Infant Nutrition
- Infectious Disease
- Nephrology
- Nutrition
- Oncology
- Pediatric Ophthalmology
- Oral Health
- Rheumatology
- Sleep
- Women’s Health
Clients:
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