Fast-forward biological drug trials with CliniExperts

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

The New Drugs & Clinical Trial Rules, 2019 establishes the procedure for Clinical Trial of Biologicals including a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, stem cell derived product, gene therapeutic product intended to be used as drug and are considered as biologicals. CliniExperts can assist

Classification of Biologicals

Biologicals are considered as new drugs, and thus, clinical trials are mandatory to launch them. These include:

Clinical trial review process for Biologicals/similar biologicals products in India

Biologicals must be validated by detailed clinical trials that prove their safety and efficacy in treating the indicated disease.

CDSCO regulates the manufacture and import of biologicals in India.

The organization is responsible for:


Approving clinical trials
Import Bio
Granting permission to import biologicals for local trials
Export Bio
Authorizing firms to export biologicals for biochemical and immunological analysis

For conducting human clinical trials, approval from the Review Committee on Genetic Manipulation (RCGM) is required.

After getting approval from the above competent authority, the application is made to CDSCO for clinical trial and/or marketing of biological/biosimilar products in India.

Clinical Trial Steps

The clinical procedures for regulating biologics and biosimilars can be exhausting.

With over a decade of experience in the clinical space, CliniExperts has all you need to ease things by taking care of all the regulatory matters and trial procedures for you.

A clinical trial application for biologics or similar biologics is submitted using Form CT-04 along with fees for various phases of clinical trial. The CDSCO then has 90 calendar days to evaluate a biological application if it is being developed outside India and 30 days if it is discovered, researched, and manufactured in India. If the CDSCO does not respond, in this time frame, permission is automatically granted. CDSCO, with the approval from the Central Government, can also waive the requirement for a local trial if the biological has already been approved outside India in certain countries as per periodic order released.

The CDSCO’s review and approval process is a three-tiered system.

Bio Step 1
Bio Step 2
Bio Step 3
Bio Step 4

Evaluation of clinical trial applications and new drugs

Review of SEC’s/IND’s recommendations

Final review and approval Final review and approval

Bio Step 2_2

Evaluation of clinical trial applications and new drugs

Review of SEC’s/IND’s recommendations

Bio Step 2_1

Final review and approval Final review and approval

Bio Step 1

Evaluation of clinical trial applications and new drugs

Bio Step 2

Attend an in-person meeting with SEC at CDSCO

Bio Step 3

Final review and approval Final review and approval

Bio Step 4

Frequently Asked Questions

Expert Articles

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 |
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 |
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.

Biologicals |
COVID-19 - Can patent waivers increase vaccine coverage?

With the new virus variant causing a surge in infections, India has been crippled by the pandemic. Apart from the shortage of medicines, oxygen and healthcare staff, several states in India face a shortage of vaccines – one of the most effective tools to end the pandemic.


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