Instem Presenting at the DIA Regulatory Submissions, Information, and Document Management Forum
Instem to present 'Gaining Intelligence from Regulatory Information Management via utilizing Medicinal Product Analytics'
CONSHOHOCKEN, PA - (BUSINESS WIRE) – January 31, 2017 - -Instem, a leading provider of IT solutions to the global early development healthcare market, is pleased to announce that Dr. Olaf Schoepke, Vice President, Regulatory Strategy, will present at the DIA Regulatory Submissions, Information, and Document Management Forum which will take place from February 6-8, 2017 in Bethesda, Maryland.
Attendees of the session will learn how to:
- Increase the effectiveness of Regulatory Information Management (RIM) beyond the traditional medicinal product life cycle to gain business advantages from existing information via Analytics
- Use RIM to help to consolidate applications, share information across the enterprise and provide a real-time view on any data required for successful medicinal product management
- Address the challenges in determining the “golden truth”, the piece of data the entire enterprise can rely on
- Utilize the ‘single place of truth’ to analyze information, enabling companies to make strategic decisions based on existing data.
“This presentation takes RIM to the next level, utilizing information beyond the pure medicinal product life cycle,” said Dr. Schoepke. Gaining Intelligence from Regulatory Information Management via utilizing Medicinal Product Analytics will be presented during Track 2: RIM Technology on Tuesday, February 7th.
For more information about this session, contact firstname.lastname@example.org or visit DIA Regulatory Submissions, Information, and Document Management Forum.
About Samarind RIM Solution
Deployed on-site or accessed on-line, Samarind RMS provides a smarter way to manage medicinal product license information, where customers only need to enter data once and reuse it as many times as required. This concept applies to all key data held within the system and is proven to streamline workload and help increase the quality of data. It is a fully integrated software application that has been purpose built to mirror the processes associated with acquiring and maintaining a pharmaceutical product license.
- A secure Regulatory Information Management (RIM) system with planning, tracking, automated alerts and comprehensive reporting facilities
- An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint
- An optional eCTD module for dossier creation and maintenance (NeeS is also supported)
- An optional EVMPD module for automated maintenance of data required by the EMA’s extended medicinal product dictionary, xEVMPD with a clear path to IDMP
- A Med Info addition, for quick and easy logging of medical information queries, with links to the associated products elsewhere in the system as necessary
- A Medical Devices module plus UDI add-on to handle any kind of medical devices
- A Drug Safety module, handling Pharmacovigilance requirements
- An Analytics module, allowing users to visualize large amounts of data in graphical format, supporting critical business decisions in real time
Some of the RMS benefits clients are realizing include:
- A ‘single place of truth’ for all product license data, minimizing information inconsistency
- Increased administrative efficiency, allowing timely response to critical deadlines
- Improved global regulatory communications via information sharing through the medicinal product life cycle
- Improved product launch planning
Samarind was acquired by Instem in 2016 to help bring scalability and next generation capabilities to the increasingly complex global regulatory environment. To find out more information about Samarind RMS and a full list of benefits, please visit www.samarindrms.com
Instem is a leading supplier of IT applications and services to the early development healthcare market delivering compelling solutions for data collection, analysis and regulatory submissions management. Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Instem’s portfolio of software solutions and consulting services increases client productivity by enhancing product development processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 500 clients through offices in the United States, United Kingdom, France, Japan, China and India.
Beth Concordia (US HQ)