Clinical Research Network India: A Contract Research Organization Standing At The Forefront Of India's Fight Against The Pandemic

Dr. Anit Singh,MBBS, MD(AIIMS)Chief Science & Innovation

Dr. Anit Singh

MBBS, MD(AIIMS)Chief Science & Innovation

As the world desperately seeks a vaccine to shield against SARS-CoV-2, we are reminded of the instrumental role the clinical research industry plays in bringing us cutting-edge medical treatments and cure. Currently, there are hundreds of registered COVID-19trials underway in India, each one of them elevating the world one level closer to finding the vaccine/cure. This is being made possible by Clinical Research Organizations (CROs), who leverage their relationship with biopharmaceutical companies to bestow the scientists/inventors with opportunities, to prove their capability and earn credibility in the hyper-competitive clinical trial industry. Besides enabling clinical research operations to focus on their patients and research, by shouldering the non-core responsibilities, many CRO also help them accelerate the study start-up process by administering various functions such as the submission processes, patient recruitment and handling data generated from the clinical studies to name a few.

In current scenario, where multiple biopharmaceutical and medical device companies across India are working at full throttle to develop a vaccine against COVID-19, an overarching CRO partner capable of offering all the solutions under single roof has become the need of the hour. Clinical Research Network India (CRN India), a nationwide Contract Research Organization, is addressing this dire need and simultaneously making significant contributions toward sending the pandemic." Currently, CRN India is involved in conducting various phases of vaccines against SARS-CoV-2 at multiple centres within India and abroad. We are proud to contribute our expertise in India's fight against COVID-19," remarks Dr. Anit Singh, Chief Science & Innovation.

CRN Indi is positioned at the forefront of the clinical trial innovation, striving to defeat the novel coronavirus, due to its unique ability to offer a comprehensive solution for executing high quality, ethical clinical research and studies, from start to finish, thereby facilitating and accelerating development of life-saving drugs, vaccines and devices. Furthermore, it also stands tallas one of the largest alliances of practicing clinicians graduated from premier medical schools such as AIIMS, PGI, MAMC and many other premier medical institutions.

The company takes pride in the fact that all of its investigators are board and GCP certified professionals and ensures that CRN India is set to meet or exceed industry standards. In fact, its science writers/researchers are also highly qualified in their respective field. Needless to say, the company vests keen importance on strictly adhering to protocols and conducts all of its clinical trials in compliance to ICH-GCP and Schedule-Y guidelines with necessary approval from Ethics committee/ Institutional review board (EC/IRB).

Overarching Services
CRN India was founded in 2015 by team of enthusiastic professionals to address the need for a consortium of experienced clinicians, expert researchers and clinical research sites, all in one place, to aid investigators in conducting high level research and accelerate development of medical products/devices. Since its inception, the company has successfully conducted multiple clinical trials (Phase I ­ IV clinical trials) on various drugs, biologicals, vaccines for different sponsors and was also involved in promoting the same in the market.

CRN India lives by its mission of enabling all investigators/inventors in their research by providing them infrastructure to run a performance-driven, cost-effective, ethical, unbiased and hassle-free clinical trial. To achieve that, the company partners with qualified professionals such as researchers, clinicians, board and GCP certified practicing primary care physicians in diverse core therapeutic areas, clinical research organizations, site management organizations, the Government, health associations, not-for-profit organizations, biopharmaceutical and medical device companies as well as the patients and public that allow CRN India to provide convenient solution to potential hurdles associated with conducting clinical research in India. "Our partners from different fields, team together with the client and work as a well-oiled machine, to deliver quality results within time and answer any queries of the client, during as well after the trial has been conducted," remarks Dr Nidhi Rai, Director ­ Clinical Operations, CRN India.

The company provides end-to-end trial management services for sponsors to meet their requirements for phase I-IV studies with the option to choose standalone services or package of services. Its services include investigator selection, research site identification, clinical study approval (including ethics committee/ institutional review board approval), protocol development (background research, writing study protocols and reports, data analysis and others) and most importantly a fast, secure ethical conduct of the study ensuring sanctity of the clients' intellectual property. Furthermore, CRN India offers practical help in identifying and recruiting patients for Portfolio studies so that researchers can be confident of completing the study on time high quality Phase I ­ IV clinical trials on vaccines, drugs and devices in both adult and paediatric population. Besides experienced investigators, it also provides science writers as another value-added service.

Consortium Of Experts
CRN India has researchers and experts from various sphere of medical, biopharmaceutical, immunological areas that are divided into Pharmaceutical and Vaccine Research group and Regulatory Affairs. The
research group and affiliated laboratory seeks to understand bacterial and viral vaccine response important to public health. The vaccine group evaluates vaccine through a series of trials to assess product for safety, immunogenicity and efficacy before they are approved for marketing licensure. CRN India possesses experience in the streams of COVID-19 Vaccines, Rotavirus Vaccine, Typhoid Vaccine, Japanese Encephalitis Vaccine, Rabies Vaccine, Pentavalent Vaccine/ DPT/ Hib/ Hepatitis B Vaccines, Hepatitis A Vaccine, Oral Polio/ Injectable Polio Vaccine, Hexavalent Vaccine and Influenza vaccine. Pharmaceutical Research group has expertise in almost all major therapeutic areas especially Oncology, Cardio, Respiratory, Orthopaedics and Neurology etc.

On the other hand, the company's Regulation and Governance expert team is comprised of professionals experienced in handling product development and registration of products with regulatory authorities CDSCO (DCG India). "Our team guides you through potential regulatory hurdles to ensure highest quality of regulatory dossier submission, compliant with regional and local requirements, which has high probability of acceptance. Furthermore, our group of professional aid in product development and management, promising efficient and successful approval," explains Dr. Anupriya Khare Roy, Director ­ Science & Communication, CRN India.

CRN India's experts also keep vigil on all regulations (regional and/or local), directives, and guidelines to guarantee optimized product development, registration and planning. Moreover, the company also provides comprehensive regulatory consulting for regulatory approvals for Phases I-IV clinical trial applications and marketing applications, approval of import license of drugs, product registration for marketing authorization Regulatory dossier compilation and lifecycle management Strategic consulting.

In-House Training & Certifications
Strongly believing that clinical research professionals must possess all the skills, tools, knowledge and proficiency in conducting and managing clinical studies, CRN India offers the most robust, effective, simplistic yet comprehensive GCP Certification program. The course modules are based on principles defined in ICH-GCP Guidelines and CFR for clinical research trials (U.S.), which enables its people to leverage an international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting bio-medical and behavioural research studies concerning human population.

As sponsors, CROs, SMOs and hospitals involved in conducting clinical trials are increasingly looking for certified Clinical Research Coordinators (CRC), CRN India nurtures research professionals who specialize in working with the Clinical Investigator by supporting, facilitating and coordinating the daily clinical trial activities and plays a critical role in conducting the study. Similarly, the company provides a Clinical Research Associate (CRA) Certification course that trains professionals to perform with high quality work and ethical standards.

Our partners from different fields, team together with the client and work as a well-oiled machine, to deliver quality results within time and answer any queries of the client, during as well after the trial has been conducted

Adeptly monitoring clinical trials and research studies, the company's CRAs practice FDA-approved methodology, monitor clinical trials and ensure that the trials adhere to established guidelines, regulations and SOPs. "We ensure that our employee are highly qualified professionals who have received the necessary training and certification and are up to date with the scientific and technologic advancements around the globe," asserts Dr. Anit.

The Road Ahead
CRN India foresees a significant increase in health market, especially the advent of multiple organizations in diverse areas of medicines. "The development of new technologies and inventions shaping into new products and devices would require ethical clinical trials to assess their success, which will provide CRN India the market opportunities to flourish exponentially," anticipates Dr. Anit. The company has laid out a vision to become the largest CRO in the India that would be committed to serve national and international pharma, biotech, medical device, diagnostic, food-nutraceutical, cosmetic industries.

En route to achieve this, CRN India is continuously adding more clinicians, researcher and research sites across country to its already wide database, for the benefit of its sponsors. Taking long strides towards its goal of providing healthy life to every individual through translational research by facilitating ethical clinical research in the country, CRN India is all set to make a bigger positive impact in the clinical trial industry.

Dr. Anit Singh, MBBS, MD(AIIMS)Chief Science & Innovation
The extensive clinical trial experience Dr. Anit has garnered from his tenure at pharmaceutical legend spacked up with his MBBS & MD (AIIMS) degrees, enables him to expertly cater to his client's requirements. Whereas his passion to innovate and commitment to serve the society coupled with his entrepreneurial spirit facilitate him to steer CRN India to newer heights. So far, he has participated in 200 clinical trials worldwide and has over 50 publications and abstracts to his credit.

“CRN India foresees a significant increase in health market, especially the advent of multiple organizations in diverse areas of medicines”

He is also working as Medical Advisor to Multi Vaccines Development Program (MVDP) developed by the collaborative efforts of Department of Biotechnology, Ministry of Science and Technology, Government of India, and International Centre for Genetic Engineering and Biotechnology, New Delhi which is a unique intergovernmental organisation established as a special project of United Nations Industrial Development Organization (UNIDO) with mission to advance and accelerate cost effective development of vaccines against infectious diseases.

Dr. Nidhi Rai, Country Director ­ Clinical Operations
Possessing a Masters in Business Administration and a PhD in Pharmaceutical Sciences, Nidhi has earned ample experience from several prestigious biopharmaceutical organizations in U.S., Europe, China and Russia throughout her career. She has vast expertise in almost all major therapeutic fields and is passionate about clinical project management and getting through regulatory. During her career in clinical research, she mentored many clinical research professionals, CRAs and Project Manager and making them global leaders for MNCs.

Dr. Anupriya Khare Roy, Director ­ Science & Communication
A scientific researcher with nearly a quarter century of experience in the field of Life Sciences, Dr. Anupriya is well-versed with immune system functioning and advanced cutting-edge biomedical techniques that are employed in current medical research. Holding degrees in Bachelors (Honours) in Microbiology from Delhi University, Masters in Biotechnology from AIIMS, Ph.D in Immunology from National Institute of Immunology (NII) and having worked as Post-doctoral and Research Associate at University of Pittsburgh, USA, she has vast experience in translational clinical research ranges from designing animal models to conducting human patient studies.

Location: New Delhi
Offerings: Clinical Trial Management, Clinical Data Management & Biostatistical Services, Research Site Identification, Clinical Study Approval, Science Writing, Protocol Development (study feasibility, background research, writing study protocols and reports, data analysis, and many more) and Regulatory submissions

CRN India in Spotlight:
• Conducts all of its clinical trials in compliance to ICH-GCP and Schedule Y guidelines with necessary approval from Ethics committee/ Institutional review board (EC/IRB)
• All of its investigators are board and GCP certified professionals and ensure CRN India is set to meet or exceed industry standards
• Involved in conducting various phases of vaccines against SARS-CoV-2 at multiple centres within India