Phlexglobal and Arkivum Join Forces to Enable Trial Master File Data Compliance Over Its Entire Extended Lifecycle

Unified solution provides seamless method for meeting long-term TMF archiving requirements

MALVERN, PA — A newly announced technical partnership between Arkivum, recognized internationally for its cross-sector expertise in archiving and digital preservation, and Phlexglobal, a leading provider of clinical and regulatory software and services for the life sciences industry, will enable Phlexglobal’s customers to achieve and maintain compliance over the entire Trial Master File (TMF) lifecycle, covering both the live trial and the statutory upcoming 25-year archiving period – or longer – as required.

The integrated solution between PhlexTMF and Arkivum Trust is available immediately for sponsors of clinical trials and clinical research organizations (CROs). Users can leverage PhlexTMF to bring order, stability, and control to trial master files while attaining the highest standards of completeness, timeliness and quality, then keep archived trial data safely alive in an immutable, trustworthy format that ensures prompt, painless access and reference. In addition to maximizing GxP compliance, the integrated solution will facilitate insight and discovery, enabling sponsors to derive optimum long-term value – both scientific and economic – from their data and intellectual property.

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The partnership has grown from a relationship established in 2016 between Phlexglobal and Arkivum. Since then, expectations and capacities for the management of eTMF and e-archiving have grown considerably, and the partners are in a position to offer a state-of-the-art eTMF service that prioritizes compliance and preservation while offering ease of use and efficiency. Arkivum’s experience in life sciences is complemented by credentials gained in other innovative, data-intensive sectors, including scientific research. The company has recently been awarded a project with CERN, the European Organization for Nuclear Research.

Commenting on the partnership with Phlexglobal, Arkivum’s VP of Product, Sinéad McKeown said:

“We know that inspection-readiness and minimisation of risk, along with visibility and interoperability, are of prime importance to sponsors and CROs as they steward clinical-trial data at every stage of its lifecycle. Through this partnership, Phlexglobal, backed by Arkivum, can offer its customers an end-to-end eTMF solution that is robust and user-friendly, and which plays a key role in regulatory compliance in both the immediate and longer term.

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“All of Arkivum’s digital archiving services operate on the FAIR principles – Findable, Accessible, Interoperable, Reusable – and incorporate an insurance-backed 100% data integrity guarantee. Moreover, Arkivum Trust, which adheres to ALCOA+ guidelines, is dedicated to meeting and anticipating the evolving archiving needs of the life sciences and pharmaceutical sector in multiple contexts: audits and inspections; scientific discovery; pharmacovigilance; new formulations and marketing approvals, and also corporate processes such as licensing, partnerships, and due diligence for mergers and acquisitions.”

Jim Nichols, Vice President, Product Management at Phlexglobal, said: “Meeting clinical trial archiving requirements is a vital part of TMF Management as well as inspection readiness, and this new chapter of technological partnership between Phlexglobal and Arkivum will provide the most customer-focused, secure, and comprehensive end to end solution in the industry. Once the clinical trial is complete, the customer can simply lock the trial master file in PhlexTMF and send it to archive – this commences the automatic transfer to Arkivum Trust. Once the transfer is complete, the customer can access the archived content directly via a link on the user interface.”

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