Our success stories to tell
FDCs must be based on convincing therapeutic rationalization and be carefully justified and clinically relevant. We helped our sponsor to prove the therapeutic rationale for various FDCs by conducting PIV clinical trials in India for gastroenterology, Gynaecology and Respiratory therapeutic areas
PMS/PSUR being conditioned for Market Authorization and licensing in India. The PSURs are to be submitted every six months for the first two years of the approval and for subsequent two years annually. We have conducted/conducting PMS studies for our sponsor as per “New Drugs and Clinical Trials Rule, 2019”. This has helped the sponsor to meet the prerequisites as per the regulations
To claim marketed drugs with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug (SNDs) approval required from CDSCO. Here, CliniExperts supported our client to conduct PIII, PIV and PMS studies as per CDSCO guidelines
Clinical trials for phytopharmaceutical drugs to be conducted as per applicable Rules and guidelines for new drugs. CliniExperts Research conducted three PIII clinical trials for three therapeutic conditions in India
CliniExperts has helped in conducting PII, PIII and PIV clinical trial in diversified therapeutic categories like Polycystic Ovary Syndrome (PCOS), Recurrent ascites with liver cirrhosis, Premenstrual Syndrome, Primary Dysmenorrhea and Alopecia Areata in children and adolescents
Most of the patients in intensive care unit (ICU) with impaired oral food consumption, present nutritional challenges which needs to be compensated using enteral tube feeding (ETF). We have successfully conducted safety and tolerance of nutritional supplements via tube feeding in hospitalized patients
Functional food supplements has grown exponentially in India and to prove their claims, feasibility and safety evaluation studies are required. CliniExperts Research has conducted various studies to prove their claims like Glycaemic Index evaluation of product on Diabetic and Pre-diabetic population and many more
CliniExperts can empower the sponsors to conduct successful clinical trials
and drug launches that follow the correct procedures and compliances
Drug categories for which clinical trials
can be conducted in India:
Fixed Dose Combinations
Investigational New Drug
Subsequent New Drug
Clinical Trial for Drug
Local Clinical Trial & Global Clinical Trial
Clinical trial, conducted as part of national & multi-national clinical development of a drug
- Aims to find the best dose of a new drug with the fewest side effects
- Tested on group of 15 to 30 patients
- Test’s a drug’s safety
- Assess safety as well as if a drug works.
- Done in larger groups of patients compared to Phase 1
- Often, new combinations of drugs are tested.
- Compares a new drug to the standard-of-care drug.
- Assess the side effects of each drug and which drug works better.
- Enrolls 100 or more patients.
- Often, these trials are randomized
- Needed before the FDA will approve the use of a new drug for the general public.
- Tests new drugs approved by the FDA
- The drug is tested in several hundreds or thousands of patients.
- Allows for better research on short-lived and long-lasting side effects and safety
Click here to know more about our expertise in phase 3 clinical trial