A simple change delivers faster study start-up

Life science industry reports indicate that early stages of study start-up take twice as long today as they did five years ago. As trials have grown in complexity, so too have data collection activities related to site identification, feasibility ranking, and site selection, as well as the masses of paperwork related to IRB and ethics committee approvals. The processes used to gather, organise and share all this information are largely unchanged. In a recent survey, fewer than a quarter of operations teams report using site portals – and more than 81% admit to still using spreadsheets to plot their start-up process.

Spreadsheets are a suboptimal study start-up solution for several reasons. Manual processes are not only time-consuming, but they are susceptible to human error, difficult to troubleshoot, and obstructive to regulatory compliance. Furthermore, paper-based information exchange methods require multiple document handoffs between study partners, lacking immediacy that slows decision making.

Operations teams are grasping the value of automating key components of study start-up by turning to products like Remarque Study Start-up, which combine the ease of spreadsheets with an approach specifically designed for activity tracking and project management. Such systems eliminate the issues with paper-based approaches and deliver additional transformative advantages.

Remarque Systems was put to the test when a pharmaceutical company raced to begin phase III trials for a potential COVID-19 therapy. With the pandemic as a catalyst, the team harnessed technology to accelerate their processes and turned to Remarque for solutions. Remarque was able to supply solutions in an easily implemented, technology-agnostic platform. In short order, the sponsor was able to identify and onboard sites with active onsite clinical research staff, active IRB with rapid turnaround, and a significant caseload of COVID-19 patients. Critically, they moved to launch in under a month.

Configurable technology can simplify and speed every aspect of study start-up and deliver a project management-driven approach to site start-up. By seamlessly handling all the inherent intricacies from concept to launch – faster and more efficiently than the traditional spreadsheet-based methods – can have a striking impact on study timelines. As trial start-ups face more complex demands and industry frustration grows, adopting such technology seems like the wise move.

 
This text was originally published in the European Biotechnology Magazine Spring 2021.