The complexity is set to increase and it is critical that data-driven operations are correctly managed so that companies have oversight and accountability across the life cycle of any data processing operation.
Given the huge and costly investment in therapy development it stands to reason that we should look after one of the most critical assets in the therapy development pipeline – “The data”.
However in recent years many organisations have suffered data integrity fails which have introduced costly delays during submission phases.
There are now increased expectations from regulators, payers and patients around data quality so it’s critical that companies are confident that their data-driven activities meet high standards around data integrity, quality and security.
Data Integrity is focused on ensuring that the data does not get altered or tampered with during its data management pipeline.
It’s about knowing that there are robust and fool proof systems in place to ensure the decisions made on the data have been conducted correctly and can be re-traced if required.
ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) is the standard that should be followed for the life cycle of the data. Its importance is recognised by both the MHRA and the FDA.
Data Governance ensures that standards are met through organisation policies, procedures and rules.
Embedding a Data Stewardship program within your organisation will enable the implementation of a governance framework to ensure data integrity standards are met and it will help your organisation to navigate and manage the potential risks to data integrity and quality.
Chaucer can support your business with its data stewardship service, minimising any risks you may have in your data management practices that could result in costly delays or fines to your organisation.