Transitioning to an eRegulatory platform is full of benefits; accelerated study startup, centralized document management, the ability to review and sign documents anywhere, easy task management, remote monitoring, and more. However, nearly 80% of the sites we talk to have not yet implemented this time and cost savings workflow – why is this?
The simple answer: moving to an all-digital workflow in any industry can be daunting, let alone the complex field of clinical research. Strenuous compliance regulations coupled with complicated document processes amplify an already tricky situation.
When beginning the move to an eRegulatory environment, we often hear our customers asking:
- Is eRegulatory Part 11 compliant?
- Will Sponsors and the FDA accept eRegulatory and eSource?
- Will our study teams be able to implement eRegulatory easily?
- Does eRegulatory really save time?
- Is the data secure?
- How do we choose the right eRegulatory provider?
- What steps do I need to take to get my site ready for eRegulatory?
After hundreds of successful site implementations, our team has developed a complete guide to answer those questions, available here.
Why Establishing Goals is the First Step to eRegulatory
Establishing what you plan to accomplish by moving to an eRegulatory platform will help you plan your roadmap. Knowing the why will help you develop the how.
By defining your goals, you will begin formulating a clearer picture of:
- What steps you need to take
- How you should prepare
- What software vendor you should work with
- How to measure your success
- How to implement eRegulatory at your site
Ambitious yet realistic goals are an essential part of building a strong foundation for your roadmap to eRegulatory.
Most Common Research Site eRegulatory Goals
When assisting our research sites in their move to eRegulatory the most common goals established are:
Grow: Increase study capacity without increasing employee workload or needed resources.
Be audit ready: Increase accessibility to documents and be ready when an FDA auditor or sponsor monitor walks in the door.
Speed startup: Optimize workflows and communication channels to save time and money from the constant back-and-forth.
Increase visibility: Where are my documents? Who has them? Where does work need to be done?
Track study progress: Are we on schedule? Are we hitting our organizational milestones? Are there areas of efficiency or bottlenecks that need attention?
Improve compliance: Maintain audit trails and accountability around document actions and access control.
Whether you are just beginning to think about eRegulatory, or you’re actively exploring making this time-saving transition, our team would love to answer your questions. Simply click here and get in touch. We look forward to connecting!