Backed by Science: Clinically Validating a Powerful Metabolism Booster

A U.S.-based nutraceutical startup developing a natural metabolism booster and weight management supplement aimed to clinically validate its product to support claims of increased fat oxidation, appetite regulation, and energy improvement. The trial was a key step toward securing retail partnerships and substantiating health claims under FTC and FDA guidelines. Client Challenges Conduct a 12-week, […]

Enabling Safe Cardiac Procedures: A Space Maker Device Clinical Trial

A pioneering cardiovascular device company developed a Class III implantable cardiac space maker-designed to temporarily create pericardial space during minimally invasive structural heart procedures. As a high-risk implantable device, the product required rigorous clinical investigation under FDA IDE and EU MDR for CE Marking. Client Challenges Conduct a first-in-human (FIH) and pivotal trial across multiple […]

Demonstrating the Efficacy of a Scalp/Hair Treatment Through a Controlled Clinical Study

A premium cosmeceutical brand launched a new topical hair and scalp treatment targeting androgenic alopecia and scalp inflammation. With growing demand for clinically backed beauty and wellness products, the brand aimed to substantiate its efficacy claims through a controlled clinical trial in support of both consumer trust and regulatory defensibility. Client Challenges Design a dermatologist-supervised, […]

From Post-Market Commitment to Powerful Data: A Type 2 Diabetes RWE Success Story

A top 10 pharmaceutical company had successfully launched a fixed-dose combination (FDC) therapy combining a DPP-4 inhibitor and Metformin. As part of its post-marketing commitments, the sponsor initiated a Phase 4, real-world clinical trial to assess long-term effectiveness, cardiometabolic safety, and patient adherence in diverse populations. Client Challenges Execute a large-scale, observational Phase 4 study […]

Supporting a Next-Gen Blood Pressure Monitor for FDA 510(k) and EU MDR Validation

A digital health company developed a new generation of automated, cuff-based blood pressure monitors (BPMs) with Bluetooth capability and companion mobile app integration. As a Class II medical device, clinical validation was essential for FDA 510(k) clearance and EU MDR certification. Client Challenges Capture performance across multiple user populations (age, sex, BMI) Validate data transmission […]

Accelerating Regulatory Submissions for Acne Treatment Efficacy and Tolerability

A dermatology-focused pharmaceutical company developed a novel topical gel formulation combining retinoid and anti-inflammatory agents for the treatment of mild to moderate acne vulgaris. The product was being positioned for launch in both regulated (U.S., EU) and semi-regulated markets with a goal of establishing strong clinical efficacy and a superior tolerability profile. Client Challenges Conduct […]

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 […]

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, […]

Accelerating 510(k) and EU MDR Submissions for an Orthopedic Device Trial Across 3 Regions

A U.S.based medtech company developed a novel orthopedic implant designed to support foot and ankle joint stabilization in patients with degenerative conditions and post-traumatic injuries. Preparing for FDA 510(k) clearance and CE marking, the client needed a partner to conduct a pivotal device safety and performance trial across multiple orthopedic centers. Client Challenges Execute a […]