Solution developed to help biopharmaceutical companies meet emerging regulatory requirements ahead of deadline
LONDON, November 14, 2016 – PAREXEL International Corporation (NASDAQ: PRXL), 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 Organisation for Standardisation (ISO) IDMP standards. Other major global market regulatory agencies are expected to follow suit. The standards are designed to increase transparency into authorised 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 standardised 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, specialised 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 commercialisation 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.
PAREXEL, LIQUENT Insight, and LIQUENT Insight for IDMP are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners.
This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
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Charlotte Ward, OneChocolate Communications
Tel.: 0207 347 0227
Cristi Barnett, PAREXEL International
Tel.: +1 781-434-4019