Regulatory and startup specialists are the unsung heroes who work diligently behind the scenes to pave the way for efficient trial execution. Their specialized expertise in navigating regulations and site activation plans is indispensable for smooth clinical operations.
For Sponsors, having a CRO partner with seasoned regulatory and startup specialists on board can impact clinical trials through:
- Faster and more efficient start-up timelines: Regulatory and startup specialists have deep expertise navigating country-specific submission processes and startup activities to accelerate activation.
- Reduced compliance risks: Their mastery of local regulatory guidelines ensures clinical trial applications and site documents meet all ethical and legal requirements.
What is a Regulatory and Startup Specialist?
A regulatory and startup specialist is a key clinical operations professional responsible for managing country and site-specific launch activities for clinical trials. By securing regulatory approvals and prepping sites for activation, they enable programs to start up seamlessly.
What are the typical responsibilities of a Regulatory and Startup Specialist?
Regulatory responsibilities:
- Preparing and submitting clinical trial applications to regulators and ethics committees
- Compiling submission dossiers and managing responses
- Tracking submission timelines using regulatory intelligence tools
- Interacting with regulators to secure necessary approvals
Startup responsibilities:
- Developing detailed study-specific startup plans for each site and tracking of site activation timelines in the corresponding tools
- Creating, collecting and reviewing essential documents required for IMP release
- Customizing informed consent forms and patient information sheets
- Coordinating translation of study documents related to submissions
- Collaborating with CRAs to ensure alignment in communication with sites to secure their collaboration during the startup phase
- Participating in the contracts/budget negotiation with the sites
To thrive in this role, specialists need:
- Deep knowledge of clinical research regulations including GCP guidelines
- Strong communication and organizational skills
- Meticulous attention to detail
- Ability to multitask and prioritize high workloads
The impact of Regulatory and Startup Specialists on clinical trials
By securing rapid approvals and prepping sites for immediate activation, regulatory and startup specialists add immense value:
- Accelerated study timelines and enhanced enrollment velocity
- Reduced compliance risks through expert regulatory submissions
- High quality, inspection-ready essential documents at each site
- Smoother collaboration between sites, CRAs, and sponsors
Conclusion
Regulatory and startup specialists are the unsung heroes whose work is vital to smooth clinical operations. Their specialized expertise enables rapid trial start-up and ensures programs get off the ground quickly. By mastering the intricacies of regulations and site activation, these professionals pave the way for accelerated research that benefits patients.
