What is India's share in Pharmacovigilance and Clinical Data Management industry and its future

Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects. Pharmacovigilance is majorly associated with signal detection and risk management. The main aim of pharmacovigilance is to protect patients from unnecessary harm by detecting adverse drug reactions both long term as well as a short term that were not identified during the clinical trial process. On the other hand, Clinical Data Management (CDM) is the process of collection, analysing, and management of clinical trial data in compliance with regulatory standards. The data collected should follow the principle of data integrity.

The pharmacovigilance market is divided into in-house pharmacovigilance service providers and pharmacovigilance outsourcing. The in-house pharmacovigilance section was estimated around 2 billion in 2018 and will observe extensive growth since then. Concerns related to confidentiality, data safety, accountability and obligation with outsourcing organizations are some of the major aspects give preferentiality to companies to choose internal pharmacovigilance. Large-sized companies have a preference to opt to endow their own pharmacovigilance department due to the presence of innovative technology and infrastructure along with the availability of skilled professionals and they are financially strong as well. High data security and confidentiality enabled the pharmacovigilance market to expand in the forthcoming years. The Indian pharmacovigilance market is alone accountable for significant industry share in 2018 worldwide and is poised to exceed up to USD 2.5 billion by 2025.

Large-sized companies have a preference to opt to endow their own pharmacovigilance department due to the presence of innovative technology and infrastructure along with the availability of skilled professionals and they are financially strong as well.

Global pharmaceutical industries found India to be a preferred marketplace for clinical Research and pharmacovigilance due to better acquiescence with the national and international regulatory guidelines such as the World Health Organisation, International Conference on Harmonization Good Clinical Practice (ICH-GCP) and the guidelines set forth by the U.S. FDA, proposes good opportunities for pharmacovigilance in the country. Improved knowledge and awareness among public, training of medical professionals and the presence of strict regulations for reporting of ADRs will consequently speed up the market progress in the near future. Few prominent giants operating in Indian market include Accenture, Tata consultancy services, Infosys, Cognizant, IBM Corporation, InVentiv Health Clinical, IQVIA (Quintiles IMS), ICON and PAREXEL.

The growth of IT industry in India lend a hand for the evolution of CDM  and to generate effective and high-quality clinical research data, and maintain a balance between the expectations and restraints in the existing systems. In a country like India that is driven by technological developments and business demands, this all is possible. It has reduced time and easiness in data entry, cost-effective, flexible format and the facility to capture additional information leads to a wonderful growth in the clinical data management market. With the aid of technology advancement and digitalization in clinical data management replaced the traditional data management process, henceforth producing clinical trial results of high quality. One more factor, which has augmented the growth in the clinical data management market, is an increase in the number of clinical trials in India. Industries operating the clinical data management market in India as well as globally include OmniComm Systems, Oracle Corporation, BioClinicia, ERT, PHT Corporation, MedNet Solutions Inc., PAREXEL International Corporation, eClinical Solutions Inc., Datatrak International Inc., and Medidata Solutions, Inc.

The Indian market is witnessing a noteworthy enhancement in the pharmacovigilance industry due to an increase in new drug development. Pharmacovigilance outsourcing is a common practice among pharmaceutical companies as it substantiates a cost-effective model for small and medium-sized companies. Similarly, Digitization and expansion of technology in India have effectively reduce the time taken in the process of data capturing to reporting, fastens the regulatory submissions and approval process, and ultimately lessen the time and cost of bringing new drugs and devices to the market, eventually increasing the market and demand of clinical data managers