Comprehensive Clinical Trial Solutions for your smooth drug launch in India

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:

New Drug

A drug or substance or drug delivery system of any drug which is not yet recognized by the Central licensing authority as safe and effective for certain proposed and modified claims including indication, route of administration, dosage and dosage form.

Fixed Dose Combinations

Refer to products containing two or more active ingredients in a fixed ratio used for a particular indication.

Investigational New Drug

Means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. In other words, IND is a potential drug whose safety and efficacy need to be established in human

Subsequent New Drug

A pre-approved drug that has been modified to improve the treatment for already approved indication or additional indication and is going for a subsequent trial or a drug which is under the period of 4 years.

Clinical Trial for Drug

CliniExperts provide full spectrum services for following types of Drug Clinical Trials:

Local Clinical Trial & Global Clinical Trial

Clinical trial, conducted as part of national & multi-national clinical development of a drug

Phase 1
  • 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
Phase 2
  • 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.
Phase 3
  • 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.
Phase 4
  • 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

Our clinical trial solutions,designed to address your specific needs and deliver a smooth development pathway

Efficiently manage your Drug Trials with CliniExperts

Conducting high quality trials in line with ethical and regulatory compliance

Frequently Asked Questions

Organized information about the concerns regarding Drug Clinical Trial

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;