Clinical Research Experience
A. PHARMA AND NUTRACEUTICAL TRIAL EXPERIENCE
- Randomized Placebo controlled Clinical study to evaluate the efficacy in Type 1 Diabetes Patients.
- Randomized, double blind, placebo controlled, parallel group study to evaluate the Safety and Efficacy of Investigational Product in patients with non- ulcer functional Dyspepsia.
- Qualitative study on Feminine Intimate Wash Products Involving Discussions with Gynaecologists and Consumers of Intimate Wash Products.
- A clinical study to assess the safety and efficacy of Hair tonics for hair growth and density in men and women.
- A randomized Double blind comparative cross over pilot study to evaluate the efficacy and safety of an investigational product as a sports performance and physical endurance enhancement supplement in healthy volunteers.
- An open label clinical study to evaluate the safety, tolerability and glycemic index of investigational product in healthy volunteers.
- A clinical study to evaluate the efficacy and safety of investigational product in Dementia patients having Mild to Moderate decline in Locomotor activities and impairment in Learning/Memory.
- BA/BE study of a drug (2.5mg) in Psoroasis patients.
- BA/BE study of a drug p (15mg) in Psoroasis patients.
- Safety and efficacy study of an investigational product in CKD patients.
- Safety and efficacy study of an investigational product in Head and Neck Cancer patients.
- Bio Equivalence study of an investigational product in Breast cancer patients.
- An open-label, single centre, pilot clinical study to evaluate the effect of an Investigational product on brain function in Middle aged to Elderly population by Quantitative EEG analysis and cognitive assessment tests.
- An open label, Single arm clinical study to evaluate the efficacy and safety of a product on sleep quality, stress and anxiety.
- A pilot Clinical study to assess the effect of a nutraceutical supplementation on liver health in chronic drinkers.
- A clinical study to evaluate the Bio availability of nutraceutical products through an advanced delivery system.
- Safety and efficacy of oral iron syrup in adolescents, pregnancy and postpartum.
- BA/BE study of a drug in metastatic cancer patients.
- BA/BE study of a drug in colon and metastatic colorectal cancer patients.
- BA/BE study of a drug in Ovarian cancer patients.
- Bio Availability study of two Nutraceutical formulations.
- A Randomized Placebo controlled clinical study to evaluate the effect of a nutraceutical supplementation on energy expenditure and Obesity.
- A randomized, double blind, placebo-controlled Clinical study to evaluate the safety and efficacy of a product on gestational diabetes.
B. Cosmetic and Dermatological Clinical Study Experience
- Anti-ageing studies
- Hair tonic studies
- Patch test and skin irritancy studies
- Skin care and skin lightning studies
- Anti-acne studies
- Deodorant studies
- Anti-perspirant studies
| Highlights of Project Experience | ||
|---|---|---|
| Project Description | Role & Responsibilities | |
| Gynecology | Market Authorization | eCTD Module 2 overviews |
| Cardiology | Market Authorization | eCTD Module 2 overviews |
| Cardiology | Market Authorization | RMP and eCTD Module 2 overviews |
| Oncology | Market Authorization | RMP and eCTD Module 2 overviews |
| Dermatology | Phase III | CSR preparation |
| Endocrinology | Phase IV | CSR review |
| Radiology | Phase III | Clinical Summaries, ISE |
| Nutritional Supplement | Phase IV | Protocol Writing |
| Oncology | Phase III | Narrative writing |
| Endocrine | Market Authorization | eCTD 2.4, 2.5, 2.6 and 2.7 |
| Nephrology | Market Authorization | eCTD 2.4 and 2.5 |
| Infection | Market Authorization | eCTD 2.4 and 2.5 |
| GIT | Market Authorization | eCTD 2.4 and 2.5 |
| Cardiology | Phase 2 | Narrative writing |
| Oncology | Phase 3 | Narrative writing |
| Oncology | Phase 1 | Protocol writing |
| Nutritional Supplement | Phase IV | Synopsis Writing |
| Nutritional Supplement | Phase IV | Protocol Writing |
| Nutritional Supplement | Pilot study | Protocol Writing |
| Neurology | Medico-marketing | Educational Newsletter |
| Neurology | Medico-marketing | Medical Review |
| Ovarian cancer | II | Protocol draft |
| T2DM | II | Protocol draft |
| Osteoarthritis | IV | Protocol draft |
| Cervical cancer | PMS | Protocol draft |
| Seasonal allergic rhinitis | New molecule | DSUR |
Medical Writing
| Highlights of Project Experience | ||
|---|---|---|
| Project Description | Role & Responsibilities | |
| Therapeutic Area | Project Details | |
| Weight loss, Diabetes | Pilot | Protocol-Report writing |
| Weight loss, Diabetes | Pilot | Protocol-Report writing |
| Oncology | Phase I | CSR writing |
| Nutritional Supplement | Phase IV | Synopsis Writing |
| Nutritional Supplement | Phase IV | Protocol Writing |
| Nutritional Supplement | Pilot study | Protocol Writing |
| Nutritional Supplement | Phase III | CSR writing |
| Neurology (Epilepsy) | Market Authorization | eCTD Module 2 overviews |
| Psychosomatic disorder | Market Authorization | eCTD Module 2 overviews |
| Infection | Market Authorization | eCTD Module 2 overviews |
| Cardiology | Market Authorization | eCTD Module 2 overviews |
| Infection | Market Authorization | eCTD Module 2 overviews |
| Infection | Market Authorization | eCTD Module 2 overviews |
| Gastro-Intestinal | Market Authorization | eCTD Module 2 overviews |
GMP/FDA Compliance & Industry Automation
- Automated Liquid dispensing system
- Environment Control system
- Interventions Management System
- GMP- sterile area access control system
Get in Touch
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09845125293
09845125293
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