How collaboration and secure data transfer is transforming clinical trials

26th August 2020 (Last Updated August 28th, 2020 10:29)

The modern life sciences environment is increasingly focused around cloud-based work and collaboration. This requires secure, reliable and GxP-compliant data transfer software, such as that offered by Egnyte.

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How collaboration and secure data transfer is transforming clinical trials
Therapeutics, medical devices and diagnostics require effective collaboration to successfully progress from early-stage development through to clinical testing.

The modern life sciences environment is increasingly focused around cloud-based work and collaboration. This requires secure, reliable and GxP-compliant data transfer software, such as that offered by Egnyte.

Therapeutics, medical devices and diagnostics require effective collaboration to successfully progress from early-stage development through to clinical testing. This inevitably involves the transfer of very large datasets between teams at different stages, which need to be strictly monitored and regulated for maximised reliability, traceability and security. Since the 1990s, biotech and pharmaceutical companies have implemented systems designed to store, exchange and analyse data that fully comply with GxP standards, which certify that pharmaceutical products are safe, fulfil their intended use and adhere to quality processes across the supply chain.

But the technological landscape in 2020 is very different from that of the 1990s. Modern software must be prepared for this constantly evolving technological environment and capable of meeting the needs of a clinical trials industry that is increasingly going global. Today, many companies are looking to reduce IT costs and leverage new technologies, such as cloud-based software, artificial intelligence and machine learning. While this switch may appear daunting and complex, especially with uncertainly surrounding digital transformation and compliance with FDA regulations, new data infrastructure that utilises user and file-based audit trails allow administrators to track the behaviour of specific files and individuals. This helps achieve complete transparency and compliance with GxP standards. Furthermore, regional data-related governance requirements are developing to account for modern security risks to ensure that data platforms can securely track sensitive data.

Egnyte for Life Sciences streamlines compliance with these ever-increasing and more strictly enforced regulations by enabling biotech companies to manage data, documents and governance in one platform. Its cloud-based data management solutions allow companies to collaborate efficiently and securely with external partners, such as CRO or CMO, consultants and sponsors, even with very large datasets. Checksum values are assigned to every file for absolute data integrity and leveraging automation using cloud-based solutions also means that deviations can be flagged, assessed and triaged accordingly.

Clinical study reports and batch records can be shared with granular permissions to ensure that data is firewalled and secure, and only accessible to the intended reader. For large data sets, Egnyte can centralise and cache data files for use both inside and outside of the network without the latency limitations associated with older systems, as well as enabling secure remote access.

With outsourcing and global collaboration leading to data being shared across more locations than ever before, and more people working remotely, this secure and reliable transfer of data is essential. Life sciences depends on collaboration, collaboration depends on trust, and that trust depends on secure, easy-to-use data transfer systems that comply with regulations. Software is now rarely built by in-house development teams, instead, it is provided by cloud vendors, such as Egnyte. With collaboration and partnership as a core ethos of modern science, Egnyte provides ongoing support along with its software to ensure that it is effectively implemented and meets requirements in FDA 21 CFR Part 11 for data integrity. In addition, the software is rigorously scrutinised to produce a validation package that shows that the software functions correctly.

Egnyte for Life Sciences enables companies to efficiently and rapidly create a compliant repository, validate it and use it for their regulated data, all while putting less strain on IT departments and increasing security. With clinical trials going global and work being carried out remotely, cloud-based file-sharing services and automation are transforming the way clinical trials are managed.

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Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records

Drug development has changed significantly in the last decade, with a notable transition from pen-and-paper to computerised systems, as well as cloud software and AI. Whilst technological solutions offer improved efficiency and transparency, many biopharma companies struggle to adapt due to the uncertainty of how FDA regulations relate to these new technologies.

This whitepaper outlines recent technological trends, explains the specific challenges these trends pose for Quality & CSV teams, and proposes the best practices for tackling resulting compliance issues.

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