Quality in clinical research: It's more than just a line item
By: Cassandra Kennedy | September 26, 2016
How an effective quality management system can help sponsors save time, money and safely bring new drugs to market faster.
In clinical research, where it costs upwards of $2.5 billion to bring a new drug to market, it is imperative to reduce or prevent errors in your development plan. While this may seem like an ‘obvious’ remark, the impact of poor quality is significant – it adds time, cost and risk to the research process, and can negatively affect the ability to achieve drug approval. Sponsors are constantly looking for ways to improve the speed and efficiency of clinical trials but still need to ensure that their research will meet increasingly high expectations for oversight from regulators and payers. In the quest to achieve this balance, sponsors are relying more heavily on Clinical Research Organizations (CROs) and the implementation of quality management systems (QMS) to drive speed and excellence across their clinical trial program.
A QMS is a formalized system that documents processes, procedures and responsibilities for achieving quality policies and objectives. Implementing an effective QMS for clinical trials can help sponsors more efficiently complete their research goals and document it in a way that can withstand the toughest scrutiny from regulators.
A good QMS isn’t like a piece of software, or a set of requirements that get factored into a contract as a line item. It’s a continuously evolving process that delivers the greatest benefits when organizations nurture a culture of quality built around formally defined policies, design controls, metrics and action plans designed to address any issues that may arise. This ‘quality by design’ approach encircles all aspects of delivery – initiation, execution and completion – and it only works if every piece of the process is given equal attention and importance so that they can operate in unison. That includes identifying and monitoring risks and predictors of quality issues, and utilizing data comparing performance across research sites for potential triggers of quality issues.
When quality has a strong presence in a corporate culture as well as leaders who prioritize quality through their words and actions, employees make better decisions and fewer mistakes. It also eliminates the risk rogue workers will implement their own methodologies, or let small mistakes slide. CEB, a best practice insight and technology company, estimates the average company can recapture up to $350 million in employee productivity through the implementation of effective quality initiatives.
When sponsors want an effective QMS, they need to do more than just write quality measures into the contract. To achieve the desired level of confidence in the quality and efficiency of their outcomes, they need to look at their CRO as a trusted strategic partner who they are willing to collaborate with to deliver the best quality deliverables. Taking the time to build these relationships is the foundation of a good business model for any industry, whether you are building a car, designing a rocket or developing a lifesaving new drug. And it is worth the effort. A sponsor-CRO partnership that works together to create an environment and governance structure that prioritizes and rewards quality delivery doesn’t just make the clinical research process run more smoothly. It creates a culture of transparency and trust where clinical trials are conducted in compliance and patients are protected. This add speed and efficiency to the trial process, and prevents small problems from turning into significant bottlenecks that could otherwise jeopardize a trial’s outcome.