Amersham, Buckinghamshire UK and Malvern, Pennsylvania US
16 January 2017
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.
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
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
For further information, contact:
Gillian Gittens, head of marketing, Phlexglobal Ltd
Tel: +44(0)1494 720420