Food & Nutraceutical Clinical Trials
Food and Nutraceuticals are an evolving market and companies have the primary challenge of generating relevant scientific evidence to prove the safety and efficacy of different natural products that have potential health benefits for disease treatment and disease prevention.
Techsol has helped key players in this segment to determine the right study design approach with the right dose to understand study drug interaction, nutraceutical-drug interaction, and their effects on individuals under certain health conditions. We have worked with products that are used as part of sports nutrition, dietary supplements, herbal anti diabetic, herbal extract for Gastro-esophageal reflux disease, energy booster supplement, slimming supplements, sexual dysfunction, probiotics etc.
Common challenges with Nutraceutical Clinical trials
- These trials usually require larger sample sizes to account for safety and efficacy measures
- It is very difficult to pick an end-point
- Often a need to do a pilot study to gain insight into desired end results
- Harder to recruit for and have higher drop-out rates than pharmaceutical trials
We have the domain expertise and professional experience for end-to-end trial management, patient recruitment and retention, meeting trial timelines, budget, quality and compliance.
How We Can Help
Techsol has highly experienced functional teams to conduct nutraceutical trials, right from the study design to commercialization. With our expert team we provide the following services:
- Study Protocol design
- Sample Size Calculation
- Study Database / electronic case report form (eCRF) Design
- Identification of Primary and secondary data points that are ideal for statistical calculations
- End-to-end Clinical Trial Management
- Subject Recruitment and Retention strategies
- Study Data Management
- Clinical Data Statistical Analysis
- Preparation and Submission of Final Clinical Study Reports