Conduct clinical trials for medical device and in-vitro diagnostics for launch in India

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

CliniExperts efficiently support the sponsor to launch their medical device and In-vitro diagnostic with reduced time in Indian market.

We provide full spectrum for services to conduct Clinical Investigation for medical devices and Clinical Performance Evaluation studies for In-vitro diagnostic in India.

Clinical Investigation for Medical Devices

A Clinical Investigation is a systematic investigation or study in human subjects, undertaken to assess the safety and/or performance of a medical device.

Primarily required for risky medical devices (Class B, Class C and Class D) without predicates but may also be required for Class A medical devices.

Medical Devices which are new and are not approved by countries like USA, UK, EU, Japan, Australia and Canada,may also require Clinical investigation in India.

Types of Clinical Investigation Studies as per
the new Medical Device Regulations, 2017:

Pilot clinical investigation

These are clinical investigations on investigational medical devices and are carried out for the first time in human participants.

Pivotal clinical investigation

Pivotal clinical investigation on an investigational medical device is made on the basis of data emerged from pilot clinical investigation

Clinical Performance Evaluation for In-vitro diagnostic medical device

The Clinical Performance Evaluation means the systematic performance study of a new in vitro diagnostic medical device on specimens collected from human participants to assess its performance (whether it is suitable for the purpose(s) and the population(s) for which it is intended).

Required for risky IVD (Class B, Class C and Class D)without predicates and may also be required for Class A IVD's.

The IVD's that mandatorily require Clinical Performance
Evaluation includes but not limited to

Process Involved

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Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Site addition/ deletion related notification; as applicable

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations

Registration on CTRI before enrolling the first participant

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations

Site addition/ deletion related notification; as applicable

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Registration on CTRI before enrolling the first participant

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Obtain approval from CDSCO as per Medical Device Rule 2017

Site addition/ deletion related notification; as applicable

Receive SEC recommendations

Registration on CTRI before enrolling the first participant

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Medical Step 1

Review by the Subject Expert Committee (SEC)

Compile clinical performance evaluation report/ clinical investigation report application dossier

Medical Step 2

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Medical Step 3

Registration on CTRI before enrolling the first participant

/

Site addition/ deletion related notification; as applicable

Medical Step 4

Receive SEC recommendations

Submitting annual status reports to Central licensing Authority (CLA)

Medical Step 5

Major protocol amendments; as applicable

Periodic Safety Update Report (PSUR) data submission for two years post approval

Medical Step 6

After site closeout- Final CSR submission

Frequently Asked Questions

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.

“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;

Yes. As per clause (w) of rule 2 of the New Drugs and Clinical Trials Rules, 2019 modified/sustained/prolonged/controlled release and NDDS of an approved drug are always considered as new drug and hence, require prior permission from CLA before obtaining the manufacturing license from the SLA for such products.

Any new drugs or investigational new drugs imported for the purpose of clinical trial shall be kept in containers bearing labels, indicating the name of the drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation or the centre where the clinical trial is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been imported. Where a new drug or an investigational new drug is imported by the licencee on behalf of another person, the licencee shall indicate on the label of the container of the such drug, the name and address of the importer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured. No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

A subsequent new drug means 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. A subsequent new drug also includes a new drug already approved in the country.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial study of a new drug or an investigational new drug can submit application for clinical trial study

Yes. Any sponsor or investigator intended to initiate a clinical trial for new drug or investigational new drug shall obtain permission from CLA in Form CT-06. The applicant shall submit application in Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019.

In general, the timeline for disposal of an application for conduct of clinical trial study is 90 working days from the date of receipt of application. However, if the drug is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the CDSCO within 30 working days, the clinical trial will be considered to be deemed approved.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian At least 50% of members not affiliated with the institute or organization in which EC is constituted Every member of the EC shall be required to undergo such training and development programs

An application for grant of permission to conduct clinical trial of new drug or investigational new drug shall be made in Form CT-04. The application should be accompanied by the necessary documents as specified under Second Schedule along with the fees as specified under Sixth Schedule of the NDs & CTs Rules, 2019. Order issued by CDSCO on 10th Apr 2019, Form CT-04 (and other Forms) can be manually completed and uploaded in SUGAM, till all the new Forms are integrated into the online submission portal.

Expert Articles

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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.

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Medical Devices |
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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.

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Medical Devices |
Diagnostic Kits |
Biologicals |
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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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