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
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.