Nutraceuticals are an evolving market and many companies in the sector are unfamiliar with clinical trials. Nutraceutical trials offer a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis ring true in both industries.
Most common challenges in Nutraceutical trials:
- Larger sample sizes
- 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
Why Hinge Clinica?
Hinge Clinica has highly experienced functional teams to conduct nutraceutical trials, right from the study design to commercialization. Our expert team helps you in protocol designing and advise on sample size calculation strategies/justifications to reduce the sample size without compromising end points and study results. Our operations team ensures that end to end trial management, patient recruitment and retention strategies timelines, budget, quality & compliance.
We render following Services:
- Protocol design
- Sample size calculation
- KOLs (Key opinion leaders) identification
- Investigator/Site selection
- Safety &Monitoring Services
- Data management
- Full scale statistical analysis
- Study report generation
- Regulatory approvals