How to Successfully Manage Rescue Studies and Turn Around Clinical Trials Facing Failure

Drug development is challenging, with no shortage of complexities and potential setbacks. In the end, what really matters is the quality and admissibility of the data your study delivers. As scientists, we owe it to study participants and future patients to ensure the most rapid and reliable path to success.

Knowing this, it unfortunate to see how biometrics often takes a back seat within some Sponsors and at several CROs. This is despite data related issues being amongst the most common reasons for refusals to file, or complete response letters from Regulatory Agencies.

If data is compromised or under-appreciated, the impact can be catastrophic. In these moments, a specialized CRO with a deep understanding of data risks, solutions and processes is essential to course-correct and ultimately rescue the study.

The importance of biometrics in rescue studies

One of the most common reasons for study failures is poor management of data, or a lack of focus on biometrics. Biometrics is essential for collecting, analyzing, and interpreting clinical trial data in a timely and compliant manner.

When it is not treated as a core specialty, delays and errors accumulate quickly. Or even worse, important signals of issues across the entire study delivery landscape can be missed. For Sponsors facing a distressed clinical trial, the path to recovery lies in engaging with a CRO that treats biometrics as its core focus.

With specialized biometrics solutions, MMS understands the gravity of handling clinical trial data and we have continuously innovated to ensure processes are both reliable and adaptable to challenging situations. Our Transition Services provide a structured yet flexible method to rescue studies by quickly analyzing and understanding why the study conduct is failing and designing the correct intervention plan which will turn around the trajectory successfully.

The path to a successful transition

Rescuing a clinical trial does not need to increase risks or significantly expand budgets, and MMS has successfully conducted numerous project transitions with limited impact on the budget. Indeed, a failing project is likely to get worse not better, so remediating and avoiding further issues in the trial can even reduce the total delivery cost. In addition, moving the trial to MMS processes can offset transition costs, as they are optimized and automated, including through Datacise®, our proprietary technology platform.

Our approach allows us to manage the transition cost-effectively, while protecting or improving data quality and mitigating further development delays.

Sponsors facing failing or distressed clinical trials need reassurance that the transition will be smooth and manageable. This is why we created a comprehensive transition playbook, designed to streamline the process while mitigating risks. With an experienced Data Project Manager and an Executive Sponsor assigned to each project, MMS ensures that transitions are tailored to the Sponsor’s specific needs.

MMS thrives on these unique turnaround challenges, from rescuing studies with slipping timelines or data quality concerns to helping newly acquired assets move through the clinical development process.

Why changing CROs doesn’t have to be a risk

For many Sponsors, changing CROs mid-study can feel like a risky and daunting proposition. However, the MMS approach ensures that this risk is mitigated, not amplified.

Our experience and expertise allow us to adapt to even the most complex and delicate scenarios, ensuring that study data is safeguarded and timelines are met. In fact, MMS has successfully transitioned numerous rescue projects since inception, stepping in at various stages—from taking over full studies to performing crucial programming and analysis, or authoring Clinical Study Reports (CSRs).

Our approach also extends to technology. Clinical technology must be treated extremely carefully, ensuring no data risk is introduced during the transition of responsibilities and there is minimum impact on stakeholders such as CRAs and sites. We take this seriously, designing the right approach for the unique technology and situation on the individual study.

What makes MMS particularly effective in these scenarios is our holistic approach to managing a Sponsor’s data—an approach we like to call “cradle-to-grave.” We do not stop at rescuing the data or authoring a CSR; we continue to leverage our deep understanding of the data for future regulatory filings, ensuring a seamless transition to submission.

This end-to-end support has earned us a track record of success, with our regulatory teams never experiencing a refusal to file across approximately 10 submissions per year over our 18-year history.

Speeding time-to-market through expert support

Speed is of the essence in drug development, and failing studies often result in extended R&D cycle times, which can lead to substantial delays in getting a drug to market. By engaging MMS to recover a failing study, Sponsors can tap into our process-driven methodologies to improve compliance and speed up the availability of study results.

This accelerates the time-to-market, ultimately benefiting the study participants and future patients who rely on the success of these clinical trials.

If you are concerned about the progress or quality of your study, know that it does not have to spell disaster. When quality, compliance, and time-to-market are at risk, choosing a CRO partner like MMS that prioritizes biometrics will help ensure the best possible outcome for study participants and future patients.

Learn more about our Biometrics solutions to get your therapy back on track: https://mmsholdings.com/solutions/full-service-biometrics/

This article was written by CCO Ben Dudley and Sr. Director of Biometrics and Data Science Eric Harvey at MMS.