Generally – and understandably – regulatory compliance is often the highest priority and requirement for a digital archiving and preservation solution.
However, we speak with many organisations who often don’t realise the additional value their clinical data could bring them. In fact, when utilised and future-proofed, data can become a strategic asset of value for many years.
We’ve outlined a few examples below of how you may be able to create new opportunities for your data.
Of course, first and foremost the largest value properly archiving and preserving clinical data will bring you is compliance with various regulatory rules.
Failure to comply with regulations for your organisation’s location is not an event you want to be a part of. If this turns out to be the case, your organisation could suffer from:
- Critical inspection findings
- Delays in getting your drug to market
- Reputational damage
- Longer inspections
Having your historic data and records easily accessible and findable within an archive can offer significant time and cost savings when an inspection is requested.
Review outcomes and results
We’re all aware that the industry is heavily regulated and so it should with it being the centre of life-and-death scenarios for patients.
The result is that pharma companies often find themselves under fire when patient and healthcare providers’ expectations are not met – or if adverse reactions occur. The latter could result in accusations and legal proceedings.
However, data gathered during trials must produce scientifically robust benefit-risk data. Where this correlates with marketing and side-effect claims, pharma companies can use data to help negate liability claims.
Going one step further and indexing your clinical data with relevant metadata will enable efficient search so that you can find the exact document you’re looking for…when you need it most!
Repurpose data for future trials
Potentially the largest driver of additional commercial value is the re-purposing of existing drugs. Many organisations revisit and retrial approved drugs for use of another condition or disease, yet this is only possible with access to the data from the original clinical trial.
Only then can it be re-examined and studied to extend the use of an existing drug to tackle other diseases. It’s worth noting that to do this you will require access to data held from all stages of a clinical trial.
Apart from the above-mentioned benefits, sponsors who maintain an effective archive across their product portfolio will ultimately have a huge competitive advantage.
Adhering to industry best practice approaches for data and content management will ensure that your company information is within your fingertips at all times, allowing you to make quick and effective decisions using knowledge gathered over years of hard work and dedication.
Arkivum provides a data management solution for life sciences organisations that meets long-term compliance needs, at the same time supporting strategic, high-value use cases throughout the whole lifecycle of the clinical trial data.
If you would like to speak to our team regarding your data management, please let us know here.
25 Nov, 2021
Webinar Recording: Clinical data integrity
13 Oct, 2021
eTMF & Clinical Trial Glossary
27 Apr, 2021