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Fast-Tracking FDA (U.S.) & EFSA (Europe) Submissions for a Multinational Gut Health Study

A global wellness company was preparing to launch a probiotic and botanical-based digestive aid designed to support gut microbiota balance, reduce bloating, and improve digestive comfort. With commercialization plans in both the U.S. (FDA-compliant) and EU (EFSA-submitted) markets, a robust, multi-region clinical validation was essential.

Client Challenges

  • Execute a multicenter trial across U.S. and Europe under different regulatory standards
  • Validate both subjective endpoints (e.g., GI symptom relief) and objective markers (e.g., microbiome sequencing, stool frequency)
  • Recruit and retain >250 participants across 4 countries
  • Ensure alignment with FDA DSHEA and EFSA health claim requirements
  • Maintain centralized data integrity across sites and time zones

Clinvigilant Research Solution

Regulatory & Protocol Support

  • Designed a harmonized protocol acceptable to both U.S. IRBs and EU ethics committees
  • Supported FDA IND exemption review and EFSA dossier preparation
  • Drafted region-specific ICFs, data privacy disclosures (GDPR-compliant), and subject materials

Site Activation & International Coordination

  • Activated 7 GI-specialty sites across U.S., Germany, Spain, and the Netherlands
  • Leveraged Clinivigilant’s Global Site Network with pre-qualified PI experience in digestive trials
  • Set up local language translations, logistics, and compliance training for EU sites

Site Management & Investigator Engagement

Used Clinivigilant’s proprietary EDC + ePRO platform to:

  • Collect daily digestive symptom scores (bloating, discomfort, stool consistency)
  • Integrate home microbiome kits + lab results
  • Monitor compliance through automated alerts and pill count verification

Monitoring & Risk-Based Oversight

  • Employed remote and on-site monitoring using a risk-based model
  • Unified source document verification across regions
  • Conducted pre-lock data reconciliation audits for regulatory readiness

Outcomes

4

Countries
Enrolled

268

Participants
Randomized

94.8%

Participants
Randomized

16 weeks

(incl. follow-up)

Study
Duration

FDA & EFSA submission files delivered

Regulatory Submission Readiness

38% over
8 weeks

Mean Symptom Score Reduction

21 days post last
patient out

Time to Database
Lock

Client Testimonial

Director of Clinical Innovation
EU/US Nutraceutical Brand

“Clinivigilant was the perfect CRO partner for a global supplement trial. They helped us bridge regulatory differences, stay on time, and deliver publication-quality data.”

Value Delivered

Clinivigilant streamlined a cross-border digestive health study by effectively managing dual regulatory pathways. We ensured operational continuity, maintained data accuracy, and provided full regulatory submission support throughout the process. As a result, the client was empowered to confidently position their product in two major wellness markets.

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