The Central Startup Team facilitates comprehensive study startup on behalf of research groups for industry-sponsored oncology clinical trials. Comprehensive startup services include: initial intake and site minimum requirement collection; assignment to the central startup team; all required clinical trial management system submissions; internal and external regulatory submissions, budget development and negotiation; clinic implementation; site training/supply/access requests from site qualification to RG-activation.
Central Startup Team Goals
1. Facilitate structured intake and minimum requirement collection for newly selected industry-sponsored trials.
2. Provide comprehensive study startup services which meet research group goals and expectations and establish a foundation for successful study management
3. Provide excellent customer service and maintain regular communication with study teams and sponsors throughout the startup progress
4. Attain RG Activation within 100 days of New Study Submission to REDCap
What We Facilitate on Behalf of Research Groups
a. Active Engagement from Research Group
i. Video-on attendance and discussion at required virtual meetings (Study Kickoff and Study Handoff)
ii. Timely approvals throughout startup workflow
iii. Timely responses to “Study Team/PI Action Required” items included in the Study Startup Progress Updates each week
b. Research Group Standards/Practices
i. Financial requirements
ii. ICF development process
iii. Staff list
iv. Clinic implementation practices
If you have questions on how to request central startup support on a future industry sponsored clinical oncology trial, please email the CRS Central Startup at firstname.lastname@example.org. We are happy to answer any questions you may have.