News / 20 Jul, 2020

Phlexglobal and Arkivum join forces to enable Trial Master File data compliance over its entire extended lifecycle

Phlexglobal and Arkivum join forces to enable

Trial Master File data compliance over its entire extended lifecycle

A newly announced technical partnership between Arkivum, recognised 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 organisations (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 maximising 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.

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.

“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  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.”

About Phlexglobal

Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness.

PhlexTMF, the company’s Trial Master File software, and Regulatory Solutions including PhlexSubmission for eCTD and CTD, PhlexIDMPPhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for their out of the box best practices capabilities. use of automation technology and user-focuses design.

PhlexDistiller, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end to end solutions offering from Phlexglobal.

Press Contact:

Chris Englerth

Head, Global Marketing, Phlexglobal

Tel: +1 215 622 8798

Email: cenglerth@phlexglobal.com

 

About Arkivum                                                                                    

Arkivum is recognised internationally for its expertise in the archiving and digital preservation of valuable data and digitised assets in large volumes and multiple formats. The long-term security, integrity and accessibility of data is crucial for all Arkivum’s clients and partners, who share a commitment to good practice in its stewardship and governance.

Arkivum’s specialist software and services are chosen by major institutions and commercial organisations from a diversity of sectors, including life sciences and pharmaceuticals, corporate, nuclear research (CERN), and organisations in higher education, culture and heritage. All Arkivum’s clients benefit from an insurance-backed 100% data integrity guarantee. Among them are CERN, Princeton University, London School of Economics, ThermoFisher Scientific, Idorsia and Oncologica. Headquartered in the UK, with US offices in Boston and New York City, Arkivum advocates and implements best practice in data management, including the FAIR principles: Findable, Accessible, Interoperable, Reusable. In particular, Arkivum helps organisations to build and operate Trusted Digital Repositories for their content.

Arkivum Trust is Arkivum’s dedicated digital archiving service for life sciences and pharmaceuticals. Its TMF (trial master file) archiving function enables sponsors of clinical trials and clinical research organisations (CROs) to maximise insight and discovery along with GxP and compliance, and so derive optimum long-term value, both scientific and economic, from their data and intellectual property.

Vendor-neutral and complementary to existing eTMF systems, Arkivum Trust provides a model for the stewardship of data, minimising risk and ensuring the end-to-end integrity, security and viability of clinical trial data, whatever its source and digital format.

By keeping large volumes of trial data alive in the archive, constantly accessible and inspection-ready, Arkivum plays a crucial role in maintaining quality control and compliance. By ensuring ready access to important reference materials, it unlocks the economic value of data beyond audit and inspections, facilitating scientific discovery, pharmacovigilance, new formulations and marketing approvals. In addition, it expedites corporate processes such as licensing, the establishment of partnerships, and due diligence for mergers and acquisitions.

Tom Lynam

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