UCLA provides robust clinical research consultation services to support international clinical research organizations (i.e. clinical drug and/or medical device companies, medical centers, and, teaching universities). Consultation is provided by nationally recognized thought leaders and subject matter experts curated by UCLA.
I. Study Start-up Services:
Services designed to support effective clinical trial
study design, financial modeling and sustainability,
and streamlined study activation.
a. Clinical Trial Protocol Design
i. Protocol development and study design
ii. Statistical relevancy and study enrollment
b. Clinical Trial Budget Development Services
i. Medicare Coverage Analysis
ii. Certified Procedural Coding & Research Pricing
iii. Budget development and negotiation
iv. Sponsor and/or participating site invoice management
v. Account forensics and/or reconciliation
c. Study Activation Services
i. IRB application preparation and/or submission
ii. Informed subject consent development
iii. Study activation facilitation at UCLA (as an enrollment center)
II. Regulatory Support Services:
Services designed to support key regulatory requirements related to the performance of clinical
research studies in the United States.
a. FDA Guidance & Application Support Services
i. Development and/or review of FDA Drug and/or Medical Device Applications (e.g. IND, IDE,
ii. General FDA Consultative Support Services
b. Scientific Review & Regulatory Affairs
i. Data Safety Monitoring Board
ii. Scientific Review
iii. Regulatory and source data monitoring and auditing
III. Study Coordination Services
Services designed to facilitate subject recruitment and active clinical trial coordination efforts.
a. Single-Center Clinical Trial Coordination Service
i. Participant recruitment and/or marketing efforts
ii. Participant pre-screening
iii. Study coordination
b. Multi-Center Clinical Trial Coordination
i. Site feasibility and site selection
ii. Study activation coordination
iii. Clinical Trial Contracting
c. Central Laboratory Services
i. Central lab processing, resulting and storage
ii. Mitigates vaiances in lab norms and performance
IV. Education Services
Services designed to train and prepare clinical research faculty and staff in key aspects related to
performance and effective management of clinical research studies.
a. Clinical Research Training and Certification
i. Clinical Research Coordinator Certification
ii. Clinical Research Financial Management Certification
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