Will Use Trial Interactive PSMF Solution to Meet New European Medicines Agency (EMA) Regulations
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
“We were aware of the European Medicines Agency’s (EMA) impending guidance that would require all products registered in the European Union (EU) have a PSMF that can be made quickly available to regulatory authorities. We chose Trial Interactive due to its functionality and workflow in a Web-based platform with the ability to meet regulatory requirements to maintain PSMFs for all of our products. A solution like Trial Interactive is designed to allow near real-time access to global pharmacovigilance stakeholders and regulatory authorities. We expect it will play a highly valuable role in meeting the new EMA guidance,” said Catherine Godefroy, senior director, global pharmacovigilance for Aptalis.
The guideline of good pharmacovigilance practices (GVP) is a key deliverable as outlined as part of 2010 legislation enacted with 16 modules covering major pharmacovigilance processes. Module II provides guidance on maintaining a PSMF and became effective as of July 2012. With the guidance, the EMA has adjusted regulatory requirements for the PSMF to focus on the following:
The Trial Interactive PSMF solution fully complies with the new legal requirements as outlined in the Commission Implementing Regulation and as detailed in GVP Module II, and content is documented according to current standards (password control, user management, version control, archiving, etc.). TransPerfect will provide the Trial Interactive PSMF to Aptalis for all of its products in the European Union.
“Many pharmaceutical companies and contract research organizations (CROs) are already using Trial Interactive’s electronic trial master file (eTMF) and Study Start Up module to streamline clinical development in a paperless environment. Aptalis’ choice of the Trial Interactive PSMF validates that we can help life science companies in the product commercialization and lifecycle management phases to meet regulatory requirements and operate in a virtual environment,” stated Michael Smyth, general manager of TransPerfect’s Life Sciences Solutions division.
Aptalis Pharma is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP, CANASA, CARAFATE, PYLERA, RECTIV, VIOKACE, ULTRESA LACTEOL, DELURSAN, PANZYTRAT, and SALOFALK. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.
About Trial Interactive
TransPerfect’s Trial Interactive solution provides a collaborative Web-based platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update clinical trial documentation in a secure online environment. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As a part of TransPerfect’s Life Sciences division, Trial Interactive is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including product licensing and alliance management, endpoint adjudication, eTMF review/reconciliation, and pharmacovigilance. For more information, visit www.trialinteractive.com.
With annual revenues of more than $350M, TransPerfect is the world's largest privately held provider of language services and technology solutions. From offices in more than 80 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and EN 15038 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, visit www.transperfect.com.