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

  • Structured intake prior to study startup assignment
  • Minimum document collection from sponsor
  • dedicated and integrated study startup specialists assigned to each study
  • Industry and institutional implementation expertise
  • Weekly progress updates 
  • New Study Submission to REDCap
  • Clinic implementation/operations liaison with sponsor
  • OnCore Calendar receipt/vetting/finalization
  • 3rd Party Coverage Analysis receipt/finalization w/PI
  • Budget development/negotiation/finalization
  • OnCore Budget Entry vetting
  • Contract finalization/execution

  • Essential Regulatory Package & site training documentation (1572, FDFs, CVs, MLs, etc.)
  • ICF development/negotiation/finalization
  • Ancillary review submissions/approvals (SRC, Radiation Safety, HSD, IBC, IRO, etc.) 
  • Initial IRB submission/approval/correction(s)
  • Vendor certificates/portal access
  • Supplies and equipment shipment coordination
  • Internal registration with required service areas (pathology, specimen processing, UW OncoRad/TIMC, etc.)
  • SIV coordination, scheduling, and co-facilitation
  • Complete study startup file delivery
  • Detailed summary of startup activities

Partnering Expectations 

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

Contact Information

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 crsstartuprequest@fredhutch.org.  We are happy to answer any questions you may have.

Central Startup Team Members

Ashley

Assistant Director of Clinical Trial Startup, CST

Ashley oversees the CRS Startup Team which facilitates centralized comprehensive startup for industry-sponsored oncology trials on behalf of Cancer Consortium investigators. Ashley joined CRS in 2015 from the University of Washington Department of Neurology. Since then, she and her team developed and refined study startup processes strategies supporting 100-day startup timelines and standardized minimum requirements, site-sponsor expectations, and communication with internal and external stakeholders.

Madeline W

Startup Operations Manager, CST

Madeline W oversees clinical trial finance and implementation staff and facilitates the centralized comprehensive startup. Madeline W joined the CRS Central Startup Team in 2019 from the University of Washington Gynecologic Oncology Research Group.

Madhuri

Lead Startup Operations and Budget Specialist, CST

Madhuri leads internal and consortium resource development and maintenance, new portfolio intake and facilitates clinical trial finance and implementation for centralized comprehensive startup. Madhuri joined the CRS Central Startup Team in 2019 from the University of Texas Southwestern Medical Center at Dallas Endocrinology Research Group. 

Delaney

Lead Startup Operations and Budget Specialist, CST

Delaney leads consortium resource development and maintenance; and facilitates clinical trial finance and implementation for centralized comprehensive startup. Delaney joined the CRS Central Startup Team in 2020 from the University of Washington Breast Oncology Research Group.

Izzy

Startup Operations and Budget Specialist, CST

Izzy facilitates clinical trial finance and implementation for centralized comprehensive startup. Izzy joined the CRS Central Startup Team in 2022 from the University of Washington Nuclear Medicine Research Group.

Kim

Startup Operations and Budget Specialist, CST

Kim facilitates clinical trial finance and implementation for centralized comprehensive startup. Kim joined the CRS Central Startup Team in 2022, from the Center for Outcomes Research and Education in Portland, Oregon.

Shafaq

Startup Operations and Budget Specialist, CST

Shafaq facilitates clinical trial finance and implementation for centralized comprehensive startup. Shafaq joined the CRS Central Startup Team in 2022 from the University of Washington Renal/Melanoma Research Group.

Madeleine H

Lead Regulatory Coordinator, CST

Madeleine H. leads the regulatory startup for centralized comprehensive startup. Madeleine joined the CRS Central Startup Team in 2019 from the University of Washington Gastrointestinal Oncology Research Group.

Angie

Regulatory Coordinator

Angie facilitates regulatory startup of centralized comprehensive startup. Angie joined the CRS Central Startup Team in 2020 from South Sound Care Foundation in Tacoma, WA.

Farzana

Regulatory Coordinator, CST

Farzana facilitates regulatory startup of centralized comprehensive startup. Farzana joined the CRS Central Startup Team in 2021 from Christian Hospital in Quetta, Pakistan.

Josh

Regulatory Coordinator, CST

Josh facilitates regulatory startup of centralized comprehensive startup. Josh joined the CRS Central Startup Team in 2021 from the Fred Hutchinson Cancer Center NCTN Research Group.

Anna

Regulatory Coordinator, CST

Anna facilitates regulatory startup of centralized comprehensive startup. Anna joined the CRS Central Startup Team in 2022, from the University of Washington Gastrointestinal Oncology Research Group.

Allison

Clinical Research Startup Coordinator, CST

Allison facilitates coordination, communication, service area registrations, site staff accesses, trainings, and supply for the centralized comprehensive startup portfolio. Allison joined the Clinical Research Support Centralized Startup Team in 2021 from Anaheim Clinical Trials in Anaheim, CA.