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.
- 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
- 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
Global Regulatory Information Management System Market, by Deployment
Global Regulatory Information Management System Market, by Application
- Registration Management
- Regulatory Intelligence
- Labeling Management
- Submission Planning & Tracking Management
- Document Management
Global Regulatory Information Management System Market, by Enterprise Size
- Small & Medium Enterprises
- Large Enterprises
Global Regulatory Information Management System Market, by End-user
- Clinical Research Organizations
This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.
Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:
- Customer Experience Maps
- Insights and Tools based on data-driven research
- Actionable Results to meet all the business priorities
- Strategic Frameworks to boost the growth journey
The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.
The following regional segments are covered comprehensively:
- North America
- Asia Pacific
- Latin America
- The Middle East and Africa
The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.
Below is a snapshot of these quadrants.
1. Customer Experience Map
The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.
2. Insights and Tools
The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.
3. Actionable Results
The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.
4. Strategic Frameworks
The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.
The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:
1. What can be the best investment choices for venturing into new product and service lines?
2. What value propositions should businesses aim at while making new research and development funding?
3. Which regulations will be most helpful for stakeholders to boost their supply chain network?
4. Which regions might see the demand maturing in certain segments in near future?
5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?
6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?
7. Which government regulations might challenge the status of key regional markets?
8. How will the emerging political and economic scenario affect opportunities in key growth areas?
9. What are some of the value-grab opportunities in various segments?
10. What will be the barrier to entry for new players in the market?
Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.