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

Credentials

Our success stories to tell

Approval For 15+ FDCs
Approval For 6 months
Gastroenterology Gynaecology and Respiratory

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

Approval For 2 Drugs

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

Approval For 4 SNDs

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

Approval For 3 Drugs
Gynaecology Dermatology and Respiratory

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

Approval For 4 FDCs
GastroenterologyGynaecology Dermatology and Respiratory

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

Approval For 1 Supplement
Gastroenterology

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

Approval For 1 Supplement
Endocrinology

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

Expert Articles

Drug |
Biologicals |
Medical Devices |
Periodic Safety Update Report (PSURs)

Periodic safety update reports (PSUR) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug.

Drug |
Medical Devices |
Diagnostic Kits |
Biologicals |
Online submission of SAE reports through SUGAM portal

The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame.

Drug |
Medical Devices |
Diagnostic Kits |
Biologicals |
Consumer Claims |
Effective Site Management in Clinical Research - Points to Consider

Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites.

Drug |
Medical Devices |
Diagnostic Kits |
Biologicals |
Consumer Claims |
Conducting Clinical Trial During COVID-19

COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials.


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