Business Wire

Phlexglobal to Improve eTMF Document Transfers with Adoption of New Exchange Mechanism Standard

Del

Phlexglobal, a specialist provider of technology-enabled Trial Master File (TMF & eTMF) management solutions, is adopting Version 1 of the eTMF Exchange Mechanism Standard (eTMF-EMS) of the TMF Reference Model (TMF-RM) into PhlexEview, the company’s eTMF technology. This marks a major advancement in efficient document interchange and will firmly solidify Phlexglobal’s position as a driving force in eTMF management for clinical trials.

Prior to the creation of the TMF Reference Model, there was no universal methodology for the organization of trial data in an eTMF. In 2009 Phlexglobal joined other industry TMF experts to create the TMF Reference Model which has primarily focused on organizing the artifacts of a clinical trial.

While the TMF-RM has aided in the organization of artifact, the transfer of TMF to trial sponsors or contract research organizations has often required a significant amount of mapping and manipulation. Phlexglobal has extensive experience migrating millions of TMF documents across countless systems. The Exchange Mechanism Standard facilitates the transfer of this data, and by adopting it Phlexglobal will bring order to the interchange of trial master file content, metadata, audit trail and electronic signature information between organizations and systems. Phlexglobal is an active contributor in the eTMF-EMS development, providing valuable insight to the collaborative effort.

“Standardization is crucial to TMF success,” said Karen Roy, Chef Strategy Officer at Phlexglobal and the Chair of the TMF RM steering committee. “Phlexglobal has a steadfast resolution to lead the way in eTMF standards so we can ensure our customers’ records are always compliant and inspection-ready. Combined with Phlexglobal’s industry-leading expertise in TMF management, the eTMF-EMS will enable us to migrate TMF data in a variety of situations with a minimal amount of manual work.”

Ms. Roy will join other members of the TMF-RM steering committee in presenting the new standard at the DIA Annual Meeting on Tuesday, June 26 at 5:30 pm at the Westin Boston Waterfront Hotel. All attendees are encouraged to join this free event to learn how the eTMF-EMS will revolutionize data exchange. More information can be found at https://tmfrefmodel.com/category/news/. Registration is not required but would be useful for an indication of attendance.

About The TMF Reference Model eTMF-EMS

The TMF reference model eTMF-EMS subgroup was founded in 2015 and has been developing a standard which is aligned with the main TMF Reference Model to facilitate interchange of TMF content between organizations and systems.

More information can be found here: https://tmfrefmodel.com/ems/

About Phlexglobal

Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market. We offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.

Contact information

Phlexglobal Ltd
Rebecca Fuller, Marketing Executive
Tel: +44(0)1494 720420

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

LTI and PTC Unveil IoT Center of Excellence16.10.2018 14:42Pressemelding

Larsen & Toubro Infotech Ltd. (NSE: LTI, BSE: 540005), a global technology consulting and digital solutions company, in alliance with USA-based PTC Inc., today unveiled a state-of-the-art Center of Excellence (CoE) in Bengaluru, focused on Internet of Things (IoT)-based innovations. The CoE will focus specifically on Industry 4.0 solutions in Manufacturing and Oil & Gas sectors. LTI will leverage the CoE to design, build and showcase solutions for smart, connected enterprises, from proof-of-concept to industrialized deployments. The CoE will showcase the possibilities of transformative technologies to global customers, featuring Industrial IoT solutions developed on PTC’s ThingWorx® platform. LTI plans to deploy reusable IoT assets from its real-world experience in implementing enterprise-scale digital transformation solutions for global customers like L&T Construction and other global industrial manufacturing enterprises. A unique feature of the CoE will be the use of real-time data f

A Higher Intelligence: Huawei Unveils HUAWEI Mate 20 Series16.10.2018 14:08Pressemelding

Huawei Consumer Business Group (BG) today unveiled the HUAWEI Mate 20 Series. Available in 6.53-inch, 6.39-inch and 7.2-inch sizes, the HUAWEI Mate 20 Series encompasses four devices: HUAWEI Mate 20, HUAWEI Mate 20 Pro, HUAWEI Mate 20 X and PORSCHE DESIGN HUAWEI Mate 20 RS. “Smartphones are an important entrance to the digital world. The HUAWEI Mate 20 Series is designed to be the best ‘mate’ of consumers, accompanying and empowering them to enjoy a richer, more fulfilled life with their higher intelligence, unparalleled battery lives and powerful camera performance,” said Richard Yu, CEO of Huawei Consumer BG. Ultimate Performance and Battery Life Manufactured with the cutting-edge 7nm technology process, the Kirin 980 is the world’s first commercial SoC to use the Cortex-A76-based cores and Mali-G76 GPU. The Kirin 980 is also the industry’s first SoC to be equipped with Dual-NPU. In addition, it supports the 4.5G LTE Cat. 21 standard, the world’s fastest Wi-Fi connection speeds, and

New Guidance From ADA and EASD Recommends Use of Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors and Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists for Patients with Type 2 Diabetes16.10.2018 13:15Pressemelding

As the European distributor of INVOKANA ® (canagliflozin) and VOKANAMET ® (canagliflozin and metformin) Mundipharma welcomes the news that SGLT2i’s, including canagliflozin, have now been included as an important treatment option in the newly published 2018 ADA/EASD Consensus Report in the early management of T2DM patients with established ASCVD, HF, CKD and also in patients without cardiovascular disease (CVD) especially where there is a compelling need to minimize weight gain or promote weight loss or a need to minimize the risk of hypoglycaemia. The new guidance was co-published in Diabetologia, the journal of EASD, and Diabetes Care, the journal of the ADA, during the annual meeting of EASD in Berlin, Germany on October 5.1 Updates to the guidance took into consideration recent evidence from large CV outcome trials (CVOTs), which included the CANVAS programme, the largest completed and published CV outcomes trial to date for an SGLT2i, which has shown that canagliflozin reduces the

Brightree Launches First Patient App for HME16.10.2018 13:05Pressemelding

Brightree®, the leading provider of cloud-based software to help post-acute care companies improve business performance and patient outcomes, announced today from Medtrade the release of its new Patient Hub to personalize the patient experience and increase revenue for home medical equipment (HME) providers. Patient Hub is a patient engagement app that automates and simplifies how HME providers connect with their patients. It eliminates the need for multiple web portals and consolidates all patient interactions into one secure platform. By improving ease of engagement and automation, Patient Hub empowers care, frees up resources and creates opportunities to accelerate cash flow. The Patient Hub app allows providers to automate simple, repetitive processes such as sending out appointment reminders and requests for insurance updates, or delivering order status and tracking updates. Patients can initiate and complete tasks as well, including updating account information, reordering suppli

KYMCO Announces Entry Into India With Ionex16.10.2018 12:40Pressemelding

KYMCO announces its official entry into India with its game-changing Ionex electric scooter total solution. In partnership with Twenty Two Motors, an Indian company that focuses on developing advanced connected electric vehicles, KYMCO is set to revolutionize the two-wheeler sector in India by bringing the new era of electric scooters and building the open energy platforms long awaited by Indian customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181016005636/en/ Allen Ko, Chairman, KYMCO (Photo: Business Wire) India is the largest two-wheeler market in the world. The Indian government is actively promoting green movement through policies that encourage the use of electric vehicles as well as the establishment of EV infrastructure. The latest ‘National E-Mobility Programme’ aims to shift one third of petrol and diesel vehicles to electric by 2030. The government has a strong motivation for “go electric, go green” revol

AGCO Chairman, President and Chief Executive Officer Martin Richenhagen Receives the French Government's Prestigious Legion of Honor16.10.2018 12:00Pressemelding

AGCO (NYSE: AGCO), a global leader in the design, manufacture and distribution of agricultural machinery and solutions, today announces that Martin Richenhagen, Chairman, President and Chief Executive Officer of AGCO Corporation, has been named a Chevalier (Knight) of the Légion d'Honneur (Legion of Honor) by the government of France. This high-ranking honorary decoration was bestowed during a recent ceremony held at AGCO’s global headquarters in Duluth, in the presence of the French Consul General in Atlanta, Louis de Corail. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181016005270/en/ Martin Richenhagen, Chairman, President and Chief Executive Officer of AGCO Corporation, has been named a Chevalier (Knight) of the Légion d'Honneur (Legion of Honor) by the government of France during a recent ceremony in Duluth, Georgia, USA. (Photo: Business Wire) The Legion of Honor, established by Napoléon Bonaparte in 1802, is the hi