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Solution developed to help biopharmaceutical companies meet emerging regulatory requirements ahead of deadline
BOSTON, MA – PAREXEL International Corporation, a leading global biopharmaceutical services provider, today launched an Identification of Medicinal Products (IDMP)-focused solution for biopharmaceutical companies. LIQUENT InSight for IDMP is the newest module added to PAREXEL’s Regulatory Information Management (RIM) platform.
Beginning in 2018, the European Medicines Agency (EMA) will require biopharmaceutical companies to submit data on medicines in accordance with the International Organization for Standardization (ISO) IDMP standards. Other major global market regulatory agencies are expected to follow suit. The standards are designed to increase transparency into authorized and investigational medicinal products to improve patient safety.
PAREXEL’s LIQUENT InSight for IDMP allows biopharmaceutical companies to collect their data in a comprehensive and holistic manner. It is fully compliant with the five ISO IDMP standards defining product and registration data and details for investigational and registered medicinal products. In addition, PAREXEL Consulting’s subject matter experts work with clients to develop a comprehensive IDMP strategy that ensures globally standardized data.
“As biopharmaceutical companies establish their IDMP programs, they will require capabilities to help them meet global standards and eliminate complexity,” said Paul Bidez, Ph.D., Vice President, Regulatory Solutions, PAREXEL. “Our solution combines deep subject matter expertise, specialized master data management, integration services, and purpose-built technology. With this new offering, PAREXEL clients gain a well-structured IDMP program with the potential to ensure compliance, provide greater efficiency, reduce costs, and simplify processes.”
PAREXEL’s end-to-end IDMP solution is available around the world, directly from PAREXEL or through the PAREXEL Partner Program. The solution can be deployed on-premises or in PAREXEL’s Regulatory Cloud, a life sciences content and regulatory information management solution structured within a dedicated, private cloud environment. For more details, visit: https://www.parexel.com/solutions/consulting/idmp-solutions.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 18,750 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com.