Deep insight to clinical trials for the Indian market
An initiative of CliniExperts brings clinical trial services in India for local and global clinical trials
Our clinical trial solutions are designed to address your specific needs and deliver a smooth development pathway
Expert Clinical Research Services For Product Lines
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Clinical Trial Management Services
Efficiently launch your product with our customised services
At CliniExperts Research Services, we focus on conducting high-quality trials in line with ethical and regulatory compliance. We aim to be your go-to Clinical Research Organization (CRO) by offering:
Whether you are a large corporate or an up-coming startup, our clinical trial solutions are designed to address your specific needs and deliver a smooth development pathway.
Therapeutics, Diagnostics & Wellness
Test products across diverse domains
Our subject-matter experts guide you through each step of your product's launch so you don't have to worry about the hassle of regulatory approvals. Our range of services spans the following categories of products
Prerequisites for conducting clinical trials in India
Credentials
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