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Phase 1

Safety and Dosage

20-80 healthy/patients

Phase 2

Efficacy and additional Safety

100-300 patients with the target disease

Phase 3

Measure effectiveness and side effects

1000-3000 patients with the target disease

Phase 4

Post-Market Safety Monitoring

Several thousand patients with the target disease

CRD

Clinical Research Division

Overview

Clinical research refers to studies, or trials, that are done in humans with intend to explore new scientific solutions and to find better ways to treat or prevent human disease.

Clinical research and clinical trials are an important step in developing new medicines that can safely be used and distributed through the general practitioners, clinics and hospitals.

The CRD at Venus Remedies Limited enabling novel and systemized research aimed at driving the healthcare system in a positive and meaningful direction. With dedicated facilities and teams to support clinical trial and research, CRD is capable of supporting clinicians and organizations alike in the development of new healthcare drug delivery systems.

The services of the department cover the entire study cycle; from feasibility studies to archival and even more assistance provided to marketing authorization of new drugs. In line with high ethical standards, the CRD also ensures that clinical studies are conducted in compliance with regulatory requirements that ensure and protect the safety, wellbeing, and rights of the study subjects.

CRD comprises of a dynamic, vibrant and dedicated team of medical and pharmacy professionals with diverse skill sets and unique talents. We have procedures in place to fully inform participants of potential benefits and risks, to protect the confidentiality of their private information, and to protect vulnerable populations. CRD at Venus abides by the guidelines for good clinical practice of the international conference for harmonization (ICH-GCP).

We firmly believe in people engagement and ensure growth and fulfillment to our associates through our skill enhancement programs like CME programs for clinicians, nurses and allied healthcare professionals. There is a wealth of clinical knowledge to be gained from the experience of our senior doctors and other stakeholders.

We believe in equal opportunities & fairness and provide growth opportunities to associates by offering stretch assignments and the opportunity to work in cross-functional teams. Individual & team contributions are rewarded & recognized through various awards at group and unit levels.

We invite you to explore the vast possibilities at CRD and discover a rewarding life of innovation, teamwork, and achievement.

Areas Interest

Clinical research is crucial to excellence in clinical care and seems self-evident, the reason research and patient care need to exist side by side.

First and foremost, to add more advances in clinical research which offers the benefit of immediate therapies for our patients.

Second, the ability to offer clinical trials/PMS studies to patients who have diseases for which effective therapies are not available which gives both patients and their doctors a sense of hope and optimism for the future.

Finally, and most importantly, a research environment that is truly excellent attracts the best doctors, because they feel their talents will be appreciated and they want to contribute.

A good working environment that demands excellence in clinical research ensures excellence in patient care. The two are not separable. The CRD was established to ensure excellence in research at all the phases by providing the resources our scientists need to thrive. Included in this are the development of core competency, site selection, key opinion leader’s identification and the opportunity to develop collaborations across disciplines.

Antibiotic Resistance an unmet medical need of the hour

The rise of antibiotic resistance is leading to clinicians being increasingly faced with clinical failure due to the lack of effective and safe treatment options. New antibiotics clinical trials are needed now for current multi-drug resistant infections but also in preparation for emerging and anticipated threats. Hence to give more emphasis on an antibiotic clinical study.

Publications

To generate a valuable idea or piece of research and overcome the challenges for good medical writing work within the CRD department.

International PMS studies

International PMS studies would be encouraged to add more demographic safety data to our existing approved drug products.

Herbal Clinical Trial

Herbal products have become an important and indispensable part of public healthcare around the world. Various surveys on traditional and alternative medicine have highlighted their widespread use. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Hence give more emphasis on a clinical trial on Integrated natural medicine to provide a natural solution for various diseases.

Clinical Research & Division

Team Profile

Dr. Mohd Amin Mir

Director | Clinical Research

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Dr. Mohd Amin Mir
Dr. Sumit Saxena

Team Leader | Clinical Research

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Dr. Sumit Saxena
Nikhil Jolly

CRA | Clinical Research

Nikhil Jolly

Contact at: drmir@vmrcindia.com

Recently Published Work


Management of Pneumonia and Blood Stream Infections with New Antibiotic Adjuvant Entity (Ceftriaxone + Sulbactam + Disodium Edetate).
A Novel Way to Spare Carbapenems; J Clin Diagn Res. 2016 Dec; 10(12): LC23–LC27:

Mohammad Shameem and Mohammad Amin Mir

Carbapenems Sparing Antibiotics in the Management of Urinary Tract Infections Caused by Multi-Drug Resistant Gram-Negative Organisms.
A New Way to Control Growing Incidences of Carbapenem-Resistant Enterobacteriaceae:

J Basic Clin Pharma 2017;8: 34-38: Samad A, Harris H, Mir MA

Safety and efficacy of a novel drug ELORES (ceftriaxone+sulbactam+disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers.
a post-marketing surveillance study; Braz J Infect Dis. 2017 Jul - Aug;21(4):408-417:

Chaudhary M, Mir MA, Ayub SG; Protocol 06 Group.

Post-Marketing Safety and Efficacy Evaluation of a Novel Drug CSE-1034: A Drug-Use Analysis in Paediatric Patients with Hospital.
Acquired Pneumonia: Journal of Clinical and Diagnostic Research; September 2018/Volume:12/Issue:9/Page:25-28:

Manu Chaudhary, Shiekh Gazalla Ayub, Mohd Amin Mir

Comparative efficacy and safety analysis of CSE-1034: An open-labeled phase III study in community-acquired pneumonia;
Journal of Infection and Public Health. 2018 May 24. pii: S1876-0341(18)30042-X. doi: 10.1016/j.jiph.2018.04.006.

Chaudhary M, Ayub SG, Mir MA; protocol 05 group.

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