Current state of RIM in Global Life Sciences companies Technologies https://www.slideshare.net/appian/trends-in-regulatory-information-management-rim-systems-at-pharmaceutical-companies https://www.aha.org/system/files/2018-02/regulatory-overload-report.pdf https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/us-and-global-life-sciences-industry-trends-outlook.html Reference 49% of companies still rely on legacy systems and manually handle regulatory information using Excel files WinWire’s RIM (RIMTrack) RIMTrack – Key Components Electronic Common Technical Document (eCTD) Publishing Enterprise Content Management Product Registration and Commitments Submission Forecasting and Planning Identification of Medicinal Products (IDMP) Pharmaceutical Care (PC) /Safety Submission Document Management RIMTrack Cloud Ready and Big Data Analytics Healthcare and Life sciences companies know that every organizational activity from document management to product registration is regulated, and the effort devoted to compliance is expensive and time-consuming. Regulatory Information Management (RIM) systems are critical in managing reducing cost, increasing speed to market, and maximizing patient care. RIMTrack helps healthcare and life sciences organizations cut down their regulatory submissions time by 75% so that they can respond faster to business changes by For more information contact: [email protected] / www.winwire.com RIMTrack [email protected] Ready to explore how WinWire’s RIMTrack can help you efficiently manage regulatory data, processes, submissions and bring new drugs to market faster? Ask for a demo. 76% of companies utilize separate systems for each functional area of RIM 73% of companies depend on more than 4 separate systems Complexities of Compliance in Life Sciences Effects of Disintegrated and Manual Processes Why Regulatory Information Management? 629 regulatory requirements across 9 domains Crippling expenses to manage compliance ($40 billion per year) Exorbitant documentation costs related to CoP Duplicative documentation and delayed processes RIM Delayed approvals Single authoritative source of information Inefficient storages Exposure to preventable risks Long lead times to launch products Lack of trust by patients High compliance costs and risks Faster approvals and time to market Higher productivity from simplified processes Globalization of key processes Data quality improvement Increased efficiency and collaboration Submission Quality Automate Reporting and Analytics Regulatory Compliance Regulatory Affairs capabilities across the globe Regulatory Information Management - RIM Simplify Regulatory Submission Tracking Process
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Current state of RIM in Global Life Sciences companies
Technologies
https://www.slideshare.net/appian/trends-in-regulatory-information-management-rim-systems-at-pharmaceutical-companieshttps://www.aha.org/system/files/2018-02/regulatory-overload-report.pdfhttps://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/us-and-global-life-sciences-industry-trends-outlook.html
Reference
49% of companies still rely on legacy systems and manually handle regulatory information using Excel files
WinWire’s RIM (RIMTrack)
RIMTrack – Key Components
Electronic Common Technical Document (eCTD) Publishing
Enterprise Content Management
Product Registration and Commitments
Submission Forecasting and Planning
Identification of Medicinal Products (IDMP)
Pharmaceutical Care (PC)/Safety
Submission Document Management
RIMTrack
Cloud Ready and Big Data Analytics
Healthcare and Life sciences companies know that every organizational activity from document management to product registration is regulated, and the effort devoted to compliance is expensive and time-consuming. Regulatory Information Management (RIM) systems are critical in managing reducing cost, increasing speed to market, and maximizing patient care.
RIMTrack helps healthcare and life sciences organizations cut down their regulatory submissions time by 75% so that they can respond faster to
business changes by
For more information contact: [email protected] / www.winwire.com
RIMTrack
Ready to explore how WinWire’s RIMTrack can help you efficiently manage regulatory data, processes, submissions and bring new drugs to market faster? Ask for a demo.
76% of companies utilize separate systems for each functional area of RIM
73% of companies depend on more than 4 separate systems
Complexities of Compliance in Life Sciences
Effects of Disintegrated and Manual Processes
Why Regulatory Information Management?
629 regulatory requirements across 9 domains
Crippling expenses to manage compliance ($40 billion per year)
Exorbitant documentation costs related to CoP
Duplicative documentation and delayed processes
RIM
Delayed approvals
Single authoritative source of information
Inefficient storages
Exposure to preventable risks
Long lead times to launch products
Lack of trust by patients
High compliance costs and risks
Faster approvals and time to market
Higher productivity from simplified processes
Globalization of key processes
Data quality improvement
Increased efficiency and collaboration
Submission Quality
Automate Reporting and
Analytics
Regulatory Compliance
Regulatory Affairs capabilities across
the globe
Regulatory Information Management - RIM Simplify Regulatory Submission Tracking Process
Related Documents
