Business Wire

Rho, Inc. Implements Phlexglobal’s PhlexEview 4 as Transformative eTMF Solution.

Del

Phlexglobal, pioneers in the specialist provision of electronic Trial Master File (eTMF) technology and TMF services to the life sciences industry, is thrilled to announce that Chapel Hill, North Carolina-based CRO Rho, Inc. (Rho) has implemented PhlexEview4 as its chosen eTMF solution. Delivered via a private cloud in a ‘Software as a Service’ (SaaS) model, PhlexEview4 will support Rho’s commercial and government clients with greater visibility and accessibility to essential documents, and with metrics regarding the completeness and readiness of the TMF. PhlexEview provides a market-leading system for full electronic management of Rho’s client TMFs and reinforces their companywide goal to enhance the quality and speed of clinical trials.

PhlexEview is Phlexglobal’s market leading regulatory compliant, hosted solution for managing, organizing, and displaying TMF documents. Empowering users to enhance their work practices while increasing efficiencies, PhlexEview4’s innovative solutions and features span core functionality from study setup through to electronic archiving.

Phlexglobal’s technology, along with their unique breadth of market-leading TMF management solutions, organizational assets and compliance accelerators will directly impact Rho’s ability to: collaborate more effectively with the broad spectrum of TMF stakeholders; increase quality, timeliness, visibility and oversight through a centralized view of the TMF to reduce regulatory risk; and support overall Inspection Readiness. Rho uniquely offers the industry an experienced, creative team of problem-solvers who provide outstanding clinical drug development services fuelled by a unique team approach. Their dedication to collaboration makes the industry’s clinical trials and programs run smarter and more efficiently.

“Selecting an eTMF system was a strategically important decision for Rho that will allow us to add more value for our clients. We chose Phlexglobal because of the clear TMF expertise of their teams and the superior capabilities of PhlexEview4. PhlexEview4 supports collaborative partnerships with our clients and allows us to provide them with full TMF oversight and better-quality trial results.” said Laura Helms Reece, co-chief executive officer, Rho.

Following a stringent due diligence process and a complex implementation phase, PhlexEview was live at the end of October 2016. The training of 300 users is well under way and as many as 100 active studies will be available in PhlexEview.

“Rho conducted a thorough vendor selection process due to the criticality of this project to Rho’s transformation. Phlexglobal emerged as the right partner due to: the cultural fit between our teams and our shared passion for eTMF excellence; the expertise that Phlexglobal brought to bear that led to our success; and their proven ability to deliver and collaborate effectively. Phlexglobal listened and understood our objectives and requirements – a major differentiator in our experience with software vendors,” said Doug Baldwin, technical operations service leader, Rho.

We are delighted to be Rho’s long term eTMF partner and to provide PhlexEview as their eTMF management system. Every partnership we establish is based on mutually beneficial outcomes, and Rho has helped Phlexglobal to offer the industry a more transformative solution, just as we have offered them a key competitive advantage. We will continue to work collaboratively with Rho to provide them with an ever evolving solution to ensure PhlexEview continues to be in alignment with Rho business needs and the needs of their clients” said Rick Riegel, Phlexglobal CEO.

About Phlexglobal

Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services. They 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.

More information can be found at www.phlexglobal.com

About Rho

Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Their commitment to excellence, their innovative technologies, and their therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

More information can be found at www.rhoworld.com

Contact information

Phlexglobal Ltd
Gillian Gittens, head of marketing,
Tel: +44(0)1494 720420
Email: info@phlexglobal.com

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

ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 201818.7.2018 17:21Pressemelding

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, will be presenting over 20 abstracts, including data from the landmark GEMINI 1 & 2 clinical trials, at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, in Amsterdam, The Netherlands. The data being presented this year has a strong focus on novel exploratory therapeutic options and innovative treatment strategies, as well as improving awareness and understanding of key issues that continue to affect the HIV community. John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we see advancements in the treatment options available to people living with HIV, our research efforts over the past few years have been focused on moving beyond viral load and addressing some of the unresolved issues that people living with HIV face, such as the potential long-term risks and toxicities that can be associated with li

Xilam: H1 2018 Revenue: +50%18.7.2018 16:00Pressemelding

Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t

Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 12:38Pressemelding

The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign

Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 12:05Pressemelding

Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d

Sterigenics Expands European Capacity With New State-of-the-Art Gamma Sterilization Facility in the UK18.7.2018 12:00Pressemelding

Sterigenics, a Sotera Health company and leading global provider of mission-critical sterilization solutions and expert advisory services, announced today it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK. The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global HealthTM. Scheduled for completion in the fourth quarter, 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000-square-foot facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire. “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, President of Ste

Smiths Detection Technology Chosen for Standard 3 Upgrade at Helsinki Airport18.7.2018 09:05Pressemelding

Smiths Detection has been selected by Finnish airport operator, Finavia Corporation, to support the transition to Standard 3 at Helsinki Airport with approved hold baggage screening systems. Included in the contract are eight high-speed, HI-SCAN 10080 XCT scanners, which combine high resolution X-ray technology, computed tomography (CT) and advanced detection algorithms to increase both security and operational efficiency significantly. Security, speed and efficiency are critical to the extensive development programme underway at the airport, which will allow the airport to serve 30 million passengers annually and increase baggage handling capacity by 50%. “Any financial investment in upgrading security equipment has to be balanced against operational improvement, particularly when part of a major expansion. Airports need assurance that efficiencies will be gained and systems can be further updated as necessary to detect evolving explosive threats and handle ever higher volumes,” comme