Trusted Collaboration Environment: Opening new doors to real world data
A technology pathway to:
- safely access data at external collaborator sites, without data copy or data movement
- provide visibility and access to all internal datasets, in all data forms, without the need to move the data or change it’s administrator
TCE facilitate shared access to crucial data efficiently with internal and/or external collaborators with the BC Platforms’ BC|INSIGHT, BC|RQUEST and BC|SAFEBOX solutions.
The need to readily access data from internal and external sources
The pharma industry has made great strides in enabling safe, secure, and controlled access to vital data within individual organisations, for both data scientists and researchers. Irrespective of size, the vast majority of pharma, biotech, and contract research organisations have some sort of data management and internal sharing capability. The level of sophistication and utility of these solutions can vary and is often driven by individual project or programme needs.
However, it is widely recognised that ensuring data integrity and security while facilitating controlled ready access is fundamental to enabling organisations to maximise the benefits of enhanced data access. This can support both clinical trial efforts and better-informed research and drug discovery.
The TCE architecture meets the demands of national and global legislation as well as GDPR. It enables an audit trail, transparency, and data security, as well as protection of IP created from any associated research. TCE also protects proprietary algorithms used to support artificial intelligence and machine learning on real world data (RWD).
Providing the Pharma Industry faster access to the breadth of data they need requires ready access to external data as easily as internal data.
In the era of enhanced collaboration across the industry, the ability to expand this ready-access capability, to enable the sharing and utilisation of data securely between multiple organisations, is now an imperative. There is an industry wide acknowledgement that to effectively address rare types of cancer and orphan disease indications, for example, there is a requirement to open-up access to the silos of fundamental and patient specific data that exists in multiple organisations and locations across the globe. The ability to enable a researcher/investigator to securely interrogate these individual pockets of unique data at the same time has the potential to deliver a step-improvement in the level of disease understanding and insight into potential therapeutic options.
Trusted Collaboration Environment (TCE):
Augmenting in-house data sources to add breadth, depth, and richness, and most crucially enhance patient diversity, is now recognised across the industry as critical. New FDA guidance on trial participant diversity and inclusion is fueling the need for more representative populations. Access to patient data that is truly representative of the global patient population is a key component in helping to address the issue of insufficient representation of key patient types. In addition, access to such data can help alleviate the challenge of protracted trial registration phases which contribute to greater costs and increased risk of regulatory rejection. It is widely acknowledged that 9 out of 10 clinical trials worldwide are not able to recruit enough patients within their initial time frame.
Access to patient data that is truly representative of the global patient population is one of the key components helping to address clinical trial challenges.
Creating Trusted Collaboration Environments (TCEs) enable a pharma organisation the same ready access to external sources of relevant organised real world data as is delivered by internally accessible Trusted Research Environments (TREs) Such TCEs can safely and securely access an external Partners data and use it to generate research insights without moving data. With BC Platforms TCE, Partner organisations can share their data globally while adhering to their local regulatory and privacy requirements. With the nature of a partnership agreed and parameters of use and length of data access confirmed, external parties can be given their own safe portal. The portal enables the pharma organisation to see the patient level data and analyse it, but not to copy, download, export or even take a screenshot. However, TCEs do allow researchers to export the results of their proprietary analysis to help accelerate their work. Once data permissions are agreed, TCEs facilitate collaboration and ensure data integrity by keeping data safe and secure in its original location. There is full transparency and confidence that the data is secure – without compromising the ability to reach the scientific insights needed to enable rapid drug development.