Regulatory Information Management System: Introduction
- Regulatory information management (RIM) systems are capable of supporting global regulatory activities. These systems consist of various software and services for highly regulated industries such as pharmaceuticals, biotechnology, and clinical research.
- Regulatory information management software manages, controls, and drives product dossiers including regulatory product information. Regulatory information management software allows end-users to control, manage, and drive the process of bringing new products to market and manage interactions with authorities.
- The global regulatory information management system market is projected to expand at a rapid pace during the forecast period, due to an increase in demand for regulatory information management systems among end-users.
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Global Regulatory Information Management System Market: Dynamics
Global Regulatory Information Management System Market: Key Drivers and Restraints
- Increasing transformations in regulation paradigms within pharmaceuticals, medical devices, and life science sectors is estimated to boost the demand for regulatory information management systems during the forecast period.
- Increase in the number of clinical trials across the globe is one of the major factors anticipated to boost the market in the coming years.
- Rising need to reduce manual errors in regulatory processes and easy access are further expected to contribute to the growth of the global regulatory information management system market.
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- Increased complexity and new ways of managing registrations and sharing regulatory data is likely to propel the need for regulatory information management systems
- Regulatory scenarios are highly critical in the pharmaceutical, biotechnology, and clinical research sectors, which keeps getting updated at frequent intervals. This in turn is anticipated to increase the demand for regulatory information management systems during the forecast period.
- Rising adoption of cloud-based regulatory information management systems among end-users is projected to boost the demand for these systems across the globe.
- Increasing demand for real-time monitoring of regulations in the clinical trial sector is likely to propel the need for regulatory information management systems
- Rising demand for automated management of the entire workflow of product processes in real-time across the globe is anticipated to boost the demand for regulatory information management systems.
- However, lack of skilled professionals along with high cost of regulatory information management systems is expected to hamper the market during the forecast period.
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Impact of COVID-19 on the Global Regulatory Information Management System Market
- Increasing cases of COVID-19 across the globe is resulting in economic slowdown. Developed countries are strongly affected by this pandemic. Businesses have been adversely impacted in most countries due to partial or full lockdown. The supply chain industry is badly impacted during this pandemic due to closure of borders across the globe. However, COVID-19 has a positive impact on the regulatory information management system market.
- According to WHO, more than 300 clinical trials have been launched to find a treatment for COVID-19. Most of the trials are done in China and South Korea. As of April 21, 2020, over 500 clinical trials have been registered for COVID-19. Further, in April 2020, Oracle built and donated a COVID-19 Therapeutic Learning System to the U.S government that allows physicians and patients to record the effectiveness of promising COVID-19 drug therapies. Hence, increase in the number of clinical trials during COVID-19 increases the need for regulatory information management systems.
North America to Hold Major Share of the Global Regulatory Information Management System Market
- In terms of region, the global regulatory information management system market can be divided into North America, Europe, Asia Pacific, Middle East & Africa, and South America
- North America dominated the global regulatory information management system market in 2019, due to the presence of pharmaceutical stalwarts and well-established and technologically advanced companies in the U.S and Canada.
- The regulatory information management system market in Asia Pacific is projected to expand at a rapid pace during the forecast period. This can be attributed to rising number of clinical trials in the region.
Global Regulatory Information Management System Market: Competition Landscape
Several local, regional, and international players are active in the regulatory information management system market with strong presence. Rapid technological advancements have created significant opportunities in the market. Market players are gradually focusing on product launch, and mergers and acquisition with technology partners to develop innovative and advanced solutions in order to improve their offerings and market reach.
Key Players Operating in the Global Regulatory Information Management System Market
- Acuta LLC
- AMPLEXOR
- ArisGlobal LLC
- Arivis AG
- DDi, Inc.
- Ennov SA
- Extedo Gmbh
- Glemser Technologies Corporation
- Instem Group
- MasterControl, Inc.
- Parexel International Corporation
- Samarind Ltd.
- Sparta Systems, Inc.
- Veeva Systems
- Virtify, Inc.
Global Regulatory Information Management System Market: Research Scope
Global Regulatory Information Management System Market, by Component
- Solution
- Services
- Professional
- Managed
Global Regulatory Information Management System Market, by Deployment
- On-premise
- Cloud
Global Regulatory Information Management System Market, by Application
- Registration Management
- Regulatory Intelligence
- Labeling Management
- Submission Planning & Tracking Management
- Publishing
- Document Management
- Others
Global Regulatory Information Management System Market, by Enterprise Size
- Small & Medium Enterprises
- Large Enterprises
Global Regulatory Information Management System Market, by End-user
- Pharmaceutical
- Clinical Research Organizations
- Biotechnology
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