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As a leading global medical device diagnostics company, clinical teams were looking to establish a Clinical Trial Center of Excellence, a far-reaching initiative that encompasses people, processes, technology, and partners. Their goal was to set the industry gold standard for the conduct of clinical diagnostics execution.

Clinical Trial Center of Excellence

Before beginning its pursuit of clinical excellence, Clinical Affairs operated on manual processes with multiple spreadsheets and information silos. To support growth, the company needed to collaborate, track, and scale trials more efficiently, while improving data quality, reporting capability, and compliance.

They selected �Թϱ��� Clinical Operations and �Թϱ��� CDMS from �Թϱ��� MedTech as the technology foundation for its new Clinical Trial Center of Excellence. �Թϱ���’s connected platforms enabled clinical leaders to take a unified approach to clinical operations and data management.

In the first phase of its implementation, they centralized the management of non-clinical study data in �Թϱ��� CTMS and consolidated study documents in �Թϱ��� eTMF. This has streamlined the clinical trial process and allows Clinical Affairs to make faster, more informed decisions with a comprehensive, real-time view of study status. In addition, the organization is always in “inspection-ready mode,” with TMF documents at their fingertips.

Rapid Pivot to Electronic Data Capture

With �Թϱ��� CTMS and �Թϱ��� eTMF in place, this leading medical diagnostics company was ready to leverage more of �Թϱ��� MedTech’s clinical capabilities. They wanted to build on the momentum and strong partnership to integrate the clinical data management system into the clinical affairs infrastructure.

An important driver was the ability of �Թϱ��� CDMS to meet their challenging data requirements, which involve merging traditional EDC data with large, complex sequencing output files.

“Learning from �Թϱ���’s experts has helped us make the most of �Թϱ��� CDMS technologies and the agile design process.” – Clinical Data Team Lead

The team accelerated its plans when they obtained an emergency use authorization (EUA) to support COVID-19 screening programs. The organization set a goal of one month to prepare a study to test the detection of the virus in nasal and saliva samples.

The protocol development, database build, and study prep that normally occurs over a six-month period was completed in one month. CDMS was always on their roadmap, but because COVID came along, they needed a rapid way to build the database and get EDC live faster than ever before.

EDC Build in Four Weeks

Given the need for speed, the medical diagnostics company had �Թϱ��� build the COVID-19 study, while using the project to jumpstart internal enablement by having internal data managers shadow �Թϱ��� study designers as they configured the EDC system.

Leveraging agile design innovations and CRF templates for a COVID-19 study, the study was delivered within one month—with the actual work of developing and testing the database requiring less than a week.

The company’s more technical data managers were able to learn the basic rule programming in �Թϱ��� EDC, and the expanded role has improved their job satisfaction and resulted in faster study builds with no extra headcount. The move has also freed database developers to focus on building standards and any complex programming tasks.

�Թϱ��� EDC allowed study designers to easily incorporate last-minute protocol changes, a critical factor in the volatile COVID environment. Because COVID changed by the day, so did their protocol. Clinical teams were constantly going back to make changes. The flexibility that �Թϱ��� EDC offered and the way the teams collaborated really made it all possible.

Manual processes and spreadsheets slow trials down and weren’t a viable option to support this study. However, the organization was able to complete the protocol, build the database, and get the study live in a month.

Successful Adoption and Enablement

In parallel with the COVID-19 study startup, the company ran an enablement program to develop in-house EDC skills for their many clinical trials. The clinical data team lead believes that watching and participating as �Թϱ��� built the COVID-19 casebook amplified the success of the enablement program. He reports that “learning from �Թϱ���’s experts has helped us make the most of �Թϱ��� CDMS technologies and the agile design process.”

Internal teams are now using �Թϱ��� EDC to quickly configure and modify study builds on their own as the organization is well positioned to deliver on evolving EDC needs.

Ready for Innovation and Growth

�Թϱ��� MedTech plays an integral role in helping this leading medical diagnostics company drive innovation and growth.

The �Թϱ��� Clinical Platform underpins the company’s commitment to patient safety, quality, and data integrity. Ultimately, the ability to deploy and run clinical trials with greater speed, efficiency, and agility will help them bring new products to market faster.