Randomized double-blind clinical study design for health claims validation

Overview

Lead Pharma specializes in designing and conducting randomized double-blind clinical trials to validate health claims for products targeting cognitive and metabolic health. Our approach focuses on establishing both efficacy and safety, providing clients with a competitive advantage in the market. By assessing parameters like cognitive function through validated cognitive batteries or functional MRI, and metabolic health via DEXA scans, we ensure comprehensive evaluation. The studies also include safety assessments through vitals, hematology, and biochemistry, offering a full safety profile of the product.

Technical specifications

• Efficacy Parameters: Cognitive health assessments using validated cognitive batteries or functional MRI; metabolic health evaluation through DEXA scans.
• Safety Evaluations: Includes vitals such as body temperature, blood pressure, heart rate, complete blood count (CBC), renal function tests (serum creatinine), and liver function tests (AST, ALT).
• Study Duration and Visits: Conducted over 12 to 24 weeks with three key visits: Baseline, Mid visit, and End of Study.
• Data Collection: Vitals and primary endpoints assessed at all visits; laboratory parameters assessed at baseline and end of study.

Technology readiness level

This service is at Technology Readiness Level 7, indicating that it is at the demonstration stage in an operational environment. Our process includes a comprehensive validation pathway from study synopsis to clinical study report, ensuring thorough documentation and regulatory compliance.