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Drug Safety

How Data Governance Can Level Up Patient Safety

- Ingelise Bærentzen Melchiorsen, Head of Drug Safety, NNIT

Accurate and reliable data is crucial for ensuring patient safety in industries where quality of life is at play. Discover how data governance can empower your business to optimize operations, improve patient outcomes, and contribute to the advancement of health care.

The number of individual case safety reports (ICSRs) is growing faster than ever, and the regulatory requirements are constantly evolving, increasing the complexity of data to secure drug safety. This puts life science companies under pressure to streamline and optimize their drug safety operations.

For example, companies need to ensure that data such as product names, dates and personal information is recorded in the same way by everyone handling the medicine.

Several elements are involved when you want to maintain a modern approach to drug safety. One of the most important to get right is clear governance for data management, migration, and integration.

Data governance refers to the set of processes and practices implemented to ensure proper management of data related to drug safety. It involves establishing a data collection and handling framework that adheres to regulatory requirements and ensures a standardized approach to data management across the organization.

– Data and integration governance is the foundation for everything else. Soon, many life science companies will move towards the cloud and have a need for strong artificial intelligence, predictive learning, and many other tools. But this is only possible if your data is accurate, says Ingelise Bærentzen Melchiorsen, Head of Drug Safety at NNIT.

3 advantages of data governance

While data governance is the foundation for correct drug safety, it also creates value in itself. Here are three ways data governance can improve patient safety and your business as a whole:

Correct process templates, advanced supervision tools, and complying with E2B (R3) standards. These are just some examples of what managers responsible for drug safety data need to get right. Non-compliance can result in severe penalties, legal actions, and damage to a company's standing. Being able to rest assured that the data is correct should be a top priority, and data governance plays a pivotal role.

– The more guardrails you have set up for improving data quality, the more secure you can be in any scrutiny situation. With the proper solutions, you can monitor changes in work processes continuously and assess the data quality. It's all about having trust in the data, so you can sleep well at night, says Ingelise Bærentzen Melchiorsen.

Case officers should be fully confident that what they register is in compliance with the requirements. But if the processes are not standardized, errors will occur over time. Some of the most important tools for correct data in case processing are standardized drop-down menus and AI review robots that can guide case officers and minimize the manual reviewing process.

– Many reporting tasks are significantly improved when companies implement a governance structure. There is less manual work because the data is correct from the beginning, says Ingelise Bærentzen Melchiorsen.

Few top managers in the pharmaceutical industry understand the value of strengthening pharmacovigilance with data governance. Thus, there is huge business potential for companies that go the extra mile to secure data quality and control. If a drug is not safe enough, it can affect the whole company negatively, but correct data on drug safety can boost profits and help you beat the competition.

– Adverse events are important information, so you can create better medicine than your competitors, but you can only perform pharmacovigilance if you have control over your data. If you don’t have access to the data, you will never know about the problems. This type of data transparency can be achieved through strong data governance, says Ingelise Bærentzen Melchiorsen.

An easy effort

Data governance is particularly important for companies moving to the cloud, combining the cloud with on-premises legacy systems or synchronizing data across newly acquired companies. On-premises solutions are not standardized like in the cloud and many businesses will need to establish data governance to adopt important cloud-based tools.

– If you don't have control over your data governance, employees will act differently, even though they’re performing the same tasks. When this happens, inaccurate data will inevitably sneak in, creating unnecessary work and risk that can easily be avoided, says Ingelise Bærentzen Melchiorsen. She continues:

– Data processing starts from the first contact with a patient and must be consistent from then on. At NNIT, we can help analyze and standardize data, cutting away manual work and increasing drug safety. It’s an easy effort that delivers value instantly.

Contact us

Interested in knowing more about how NNIT can help with data governance and drug safety? Feel free to contact us with any questions.