By Craig Morgan, Head of Marketing, goBalto
Complexity in clinical trials continues to grow, a confluence of globalization, outsourcing, protocol complexities and ever-increasing regulatory mandates. Adding to this dilemma is the low approval rate of investigational drugs and growing development costs, the majority of which is directly attributed to running studies.
Despite the nuances between therapeutic areas the foundational phase of all clinical trials is study startup, which is widely recognized as a costly and perpetual bottleneck. Study startup is a complex business, composed of country selection, pre-study visits, site selection and initiation, regulatory document submission, budget and contract negotiations, patient recruitment initiatives, and enrolling the first patient.
Today many companies still track these site selection and activation activities manually using technology from the early 1990s:
- Tracking is performed with Excel spreadsheets
- Collaboration is done by email and siloed in disparate inboxes
- Reporting is done manually entering outdated data into a Clinical Trial Management System (CTMS)
- Documents are stored on shared drives until saved to the Trial Master File (TMF)
With multiple parties making updates, materials rapidly get out of sync, making it difficult to track the overall status of the project, as well as, compliance to regulatory and organizational SOPs – potentially resulting in downstream audit findings and rescue interventions. This lack of real-time insights prohibits the ability to pro-activity address issues, trapping the industry in an endless and costly reactive cycle.
With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start. This may seem self-evident. But how do we get there?