Vedic has been focused on Nutraceuticals, Dietary supplements and Branded ingredient preclinical and clinical trials for 22+ years.
Human Clinical Trials
Pilot studies, Proof of concept studies and efficacy Human Clinical Trials – from customized study design to manuscript publishing, Vedic houses end-to-end services. Got a regulatory submission like Novel food and GRAS to make? We cover that as well!
- Medical Writing
- Study design
- Protocol development
- Investigator’s brochure
- Clinical Study Report
- Institutional Review Board (Ethics Committee)
- Project Management
- Study Recruitment
- Sponsor communication and reporting
- Investigator’s Meeting
- Quality Assurance
- Site Monitoring
- Site Audits
- Clinical Data Management (Electronic)
- Statistical Analysis (Biostatistics)
- Objective and Subjective Tests
- Objective Measurements (Biomarkers)
- Subjective (Questionnaires, scales and computerised assessments)
- Research publishing
- Journal publishing
- Types of Clinical Trials
- Proof of Concept / Pilot Studies
- Bioavailability / Bioequivalence Trials
- First-In-Human Studies
- Large sample size Human clinical Trials
Preclinical Efficacy
Customized rodent models available on and above the available preclinical efficacy study designs for health claims like metabolism, sleep, neurobehavioural, AMPK, anti-diabetes, weight management and more!
- In-vivo models
- Neurobehavioural Activity in Rodent
- Anti-Inflammatory & Antioxidant Activity in Rodent Model
- Exercise & Endurance performance in C57BL6 Mice
- AMPK Activation in Exercising Mice
- Assessment of Enzyme Systems Downstream upon AMPK Activation in Exercising Mice Model.
- Liver Disease - NASH Model in Mice
- Liver Disease - Paracetamol-induced acute hepatotoxicity model in mice
- Assessment of Aging Markers In Rat Model
- Preclinical Efficacy Study to Examine the Effect of the Test Item (Designed for men’s health) in a Rat model
- All animal models are supported by histopathology, biomarker analysis, and relevant mechanistic assays.
- Metabolic disorders: diabetes (rats), obesity (mice), hyperlipidaemia (rabbits and hamsters), dyslipidaemia (Guinea Pig), atherosclerosis (rabbits)
- Inflammation & hypersensitivity: Pulmonary Inflammation, Atopic dermatitis, Psoriasis, Arthritis
- Peptic Ulcer models
- Hepatoprotective activity in mice
- Allergic conjunctivitis
- Charcoal meal test in rats and mice
- Forced Swim and Tail suspension test in mice
- Longevity Study in Nude Mice (6-12 months study)
Toxicity Studies
Vedic follows global standard OECD guidelines and FDA Red book guidelines available for conducting Toxicity studies. Do you know OECD 443?!
- Acute oral toxicity study (OECD 425)
- 14 day study
- 28 day study (OECD 407)
- 90 day study (OECD 408)
- In-vitro Chromosomal Aberration Test (OECD 473)
- In vitro Mammalian Cell Gene Mutation Assay on L5178Y Mouse Lymphoma cells TK+/- with test item (OECD 490)
- Mammalian erythrocyte micronucleus test of test item in Swiss albino mice (OECD 474)
- Bacterial Reverse Mutation Assay of test item Using Salmonella typhimurium and E. coli Tester Strains (OECD 471) also known as AMES test
- In-vitro Mammalian Cell Micronucleus Test Using Chinese Hamster Cell Line Culture (OECD 487)
The Vedic Process
Quick glimpse at Vedic’s standard operating procedure for conducting Preclinical safety, efficacy and Toxicity studies
Typical Toxicology Study Process
For a 90 day oral toxicity study as per OECD 408.
