Phlexglobal has announced that North Carolina-based CRO Rho has implemented PhlexEview4 as its chosen electronic trial master file (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, as well as with metrics regarding the completeness and readiness of the trial master file (TMF).
PhlexEview provides a 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 regulatory compliant, hosted solution for managing, organising, 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 its unique breadth of TMF management solutions, organisational 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 centralised 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. The company’s dedication to collaboration makes the industry’s clinical trials and programmes run smarter and more efficiently.
Co-chief executive officer of Rho Laura Helms Reece said: "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."
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.
Technical operations service leader at Rho Doug Baldwin said: "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."
Phlexglobal’s CEO Rick Riegel said: "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."