"We are clinical research lifecycle experts who support a diverse community of sponsors, patients, and investigators. We connect inspiration with execution to advance science and medicine and improve human life."
CReST was created in 2017 as a CCTSI program to fill a gap in clinical research support for investigators and clinical research teams that did not have the capacity or experience to support all of their research operations. CReST started with only two members working on a handful of clinical studies within a single department.
CReST saw rapid growth and by 2021 they had expanded to a team of 15 clinical research professionals, supporting over 130 studies with more than 70 unique investigators in 30 departments across campus. The success of CReST would not have been possible without substantial initial investment and continued support from the CCTSI.
As CReST has proved to be an integral resource to clinical research across the Anschutz campus, it was decided that CReST would move from being a CCTSI resource and operate within the Office of the Vice Chancellor for Research beginning in July 2021. This move allows CReST to expand and increase their presence and support across the campus as an institutional clinical research resource.
Request CReST's Services
Interested in engaging CReST on your study? Complete the form below to tell us about your needs and we'll get in touch (it's ok if you don't have all the answers yet.)
CReST provides a pool of experienced study coordinators and regulatory staff to assist with clinical research study start-up, implementation, and closeout. This resource alleviates the administrative burden associated with training and managing research staff and allows investigators to pay only for the amount of effort required.
Assistance with budget preparation and negotiation
Proposal routing and management
OnCore submission and sign offs
Sponsor invoicing
Hospital and CU Medicine Invoice payments
Submission to HSR portal, PRMS, External IRB review
Creation and submission of initial applications, amendments, and continuing reviews for COMIRB, WIRB, CIRB and other IRBs
Informed Consent form and subject recruitment materials development
Preparation and submission of regulatory documents (e.g. 1572, IND, IDE, Financial Disclosure Forms, CVs, etc.)
Creation and maintenance of Regulatory Binders
Preparing and maintaining ClinicalTrials.gov submissions
Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
Coordination of Site Qualification Visit
SIV scheduling and participation
Subject recruitment, prescreening and scheduling
Obtain Informed Consent (following process mandated by Sponsor/PI)
Data collection/abstraction
CRF completion/Data entry into local or external databases
Financial tracking and invoicing
Complete study visits and perform/assist with required procedures
AE and SAE reporting
Act as liaison for all subject-related communications with PI/study team
Schedule and implement monitoring visits
Prepare for and support for audits/reviews
Develop monitoring plan
Source data verification
Site initiation visits, interim monitoring visits, and close out visits
Multisite study site coordination and oversight
CReST can assist with facilitating set up and executive secretary services for Data and Safety Monitoring Board. For more information, please visit DSMB.
Pricing
The needs of a study will determine the amount of time needed by CReST team members and this will be discussed and agreed to with the investigator on a case-by-case basis.
Study type
Cost per hour (effective 7/1/2022 - 6/30/2023)
Cost per hour (effective 7/1/2023)
Startup and Administration
IRB and Regulatory
Clinical Coordination
Investigator-initiated
$65
$68
Industry-sponsored
$88
$93
Clinical Monitoring
Investigator-initiated
$88
$93
Industry-sponsored
$115
$121
Costs can increase on a yearly basis by 6% due to inflation. Studies spanning for more than one year, budget correctly for steady spending. Prices are subject to change July 1st of every year.
Micro-grants cannot be used to pay for CReST services
Payment for services will be through iLab to a university speed type
Protocol Development Workshop for Junior Faculty, Fellows, and Residents
The Clinical Research Support Center will begin a protocol development workshop on March 2023. This series of six hands-on virtual workshops. Learners should have a completed protocol ready for SARC and/or COMIRB submission by the end of the series. Must have already worked with their mentors to develop a research question and rough outline of aims/hypotheses.Free to Attend. Space is limited.