It is a well-known fact that the data that you produce as a life science organisation is often as valuable as the product that you are researching or manufacturing. Data is, as the world renowned Clive Humby appropriately said in 2006; the new oil. So, it stands to reason that data in your care should be handled as such, refined, preserved and available at point of need regardless of format.
The increasing amounts of disparate data, and an increasing number of systems and partners to manage, the ability to centralise and manage data for the long term is more challenging than ever. In regulated markets, the problem of managing data becomes even more complex as you have to maintain compliance of that data for decades and continue to meet regulatory requirements at all times, regardless of if you interact with the data or not.
In order to ensure that your research data does not become a liability you need to ensure that you are treating archived data with the same importance and strict controls as your live data.
How can my data be a liability?
Recently acquired assets consolidated (trials, compounds, research)
When life sciences organisations acquire assets such as trials, compounds, research or even entire companies (or in fact are acquired themselves) there tends to be a lot of data which needs to be consolidated into their current data estate. If this data is not consolidated it can become a liability when it comes to proving regulatory compliance, having your research data audited, or using the data for further scientific study.
Idorsia Pharmaceuticals in Switzerland had this challenge. Idorsia had been created as a completely new company and required an e-archive solution to not only store a large amount of its data but also to provide secure access for future use. The data includes previous Actelion data, data relating to inherited products returning from CROs and service providers, as well as data being generated by Idorsia itself. Read more about their story here.
Data generated by devices
A lot of data generated in research organisations is from devices used within the laboratory, this could be devices for research in genomics, chromatography, mass spectrometry etc etc. We’ve seen many organisations unsure of the most appropriate way to archive these records and often simply ‘archive’ them within live systems. This creates a huge problem as the sheer volume of data you are dealing with is increasing at a fast rate. When data is held in multiple different systems it is difficult to prove compliance and to re-use the data for further scientific study.
In order to ensure that your research data is accessible, reusable and compliant, you need to remove data silos and build a sustainable, centralised data management strategy. This ensures that you make their research data more usable for further research and discovery purposes, and easily reportable and shareable.
Oncologica, a precision oncology profiling company and Contract Research Organisation develops precision oncology solutions to personalize cancer treatments. The CRO achieves this by identifying individual genetic biomarkers, which are used to match individual patient tumours to specific medicines. Oncologica are implementing a long-term data management system to manage its regulated genomics and patient data, generated by Thermo Fisher’s Ion GeneStudio S5 next-generation sequencing (NGS) system. Read more here.
Conformance to data standards
The liability in all of the above situations comes down to the highly regulated nature of the data that Life Sciences organisations are creating. With a number of regulations that need to be considered (MHRA GxP guidelines on Data Intregrity, FDA 21CFR11, privacy regulations such as GDPR) it is important to ensure that any data is managed properly.
If an inspection is triggered, how quickly and completely can you pull together the information required to share with the inspector? How confident are you that the information compiled will meet the regulator’s requirements? For example, can you attach complete email trails from 10 years ago and match it with corresponding eSignatures? There is a lot to consider.