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Why do I need RBQM technology?

A fair question and one posed to us recently by a mid-sized sponsor. The one word answer "Complexity".

The longer, more complete answer is that clinical studies are increasingly complex. The move toward Decentralized Clinical Trials (DCTs) provides great opportunities for new insights and discoveries, as well as delivering efficiencies and savings.

But the DCT data and technology landscape is complex. New technologies, new data collection methods, multiple data sources and multiple data owners all combine to create new types of quality risks.

A common challenge is that data quality can be compromised because of gaps in treatment or patient-collected data. That means it can be difficult for clinical teams to draw statistically relevant conclusions from the data and any given patient’s data may not be deemed admissible due to being incomplete.

Complex problems need the right technologies and solutions to manage that complexity. You can’t manage all your clinical study critical process, data assumptions and risks in an Excel spreadsheet. Yet many people try.

A good RBQM solution will not only be able to manage the complexity and associated inter-dependencies, but it gives you a comprehensive and secure audit trail of all actions and changes taken place during the course of the trial. That’s extremely important when you need to show auditors and regulators who changed what data, why, when and by how much.

It will also produce analytics that enable you to understand what’s going on at the study, site, and patient level. It makes transparent and obvious what was previously opaque, including site performance, failing equipment, poor processes, missing treatment data, and perhaps most importantly, previously unseen insights into patient safety.

The right analytics allow you direct valuable resources, making more timely and effective interventions. This stops trends becoming problems by managing data quality during the study and not at the end when it’s too late.

All of which leads to building robust regulatory evidence. Providing clear, easy-to-understand reports at the touch of a button saves valuable time, as well as improving communication and collaboration with key stakeholders. Giving the regulatory authorities “data about data” supports the “scaffold of evidence” that your study was delivered to the highest possible quality management standards.

That’s a long answer to a simple question. You need RBQM because studies are complex and you need to manage that complexity in order to run a successful study.


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