Submit RFI

Supporting a Randomized Clinical Trial for Dietary Supplements

A leading nutraceutical company sought to clinically validate the efficacy and safety of its new plant-based dietary supplement designed to improve gut health and immune support. With growing regulatory expectations and consumer demand for evidence-based claims, the company needed a reliable CRO partner with expertise in dietary supplement trials.

Client Challenges

  • Conduct a randomized, double-blind, placebo-controlled trial in < 6 months
  • Enroll healthy adult volunteers aged 25–60 years
  • Navigate regulatory complexity (FDA + FSSAI compliance)
  • Ensure high data quality and protocol adherence
  • Capture both subjective outcomes (e.g. GI comfort) and biomarkers (e.g. CRP, IgA)

Clinvigilant Research Solution

Protocol Design & Regulatory Support

  • Developed protocol, ICF, and submission package for IRB & ethics clearance
  • Supported FSSAI and DCGI advisory compliance for functional foods
  • Designed a hybrid trial allowing in-clinic + remote data collection

Site Selection & Recruitment

  • Identified 3 high-throughput sites with prior supplement study experience
  • Built targeted recruitment campaigns via health & wellness communities
  • Delivered full-screening workflows and informed consent eCRF tracking

Monitoring & Quality Assurance

  • Remote + on-site CRA monitoring ensured GCP adherence
  • Conducted mid-study audit and data cleaning workshops with PI team
  • Automated protocol deviation flagging

Data Collection & Management

  • Deployed Clinivigilant EDC system with built-in dietary diary logs
  • Captured AE/SAE, compliance logs, VAS & Likert scales, and biomarker lab uploads
  • Enabled real-time data review dashboards for sponsor visibility

Outcomes

5 weeks

Enrollment Period

96%

Subject Retention Rate

< 2%

Protocol Deviations

Within 30 days
post-DB lock

Regulatory Submission Ready

4.9 / 5

Client Satisfaction
Score

Client Testimonial

Chief Medical Officer
Nutraceutical Sponsor

“Clinivigilant made the complex simple. Their EDC system, recruitment strategy, and team ownership were key to our trial success. We’ll work with them again.”

Results?

Clinivigilant Research’s integrated clinical operations, technology platform, and regulatory insight helped bring scientifically backed dietary supplements to market faster – with full confidence in data quality and safety reporting.

Ready to working with All-In-One CRO?

Together, We Accelerate Breakthroughs – Bringing New Treatments to Patients Faster
ClinVigilant

+44 1322 643254
+91 99130 11134
[email protected]

Twitter Facebook-f Linkedin Instagram

eClinical Solutions

Clinical Development

Consulting

Outsourcing Services