Clinical Trial Consultation

Researcher inserting liquid into vial with syringe

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

                        targets

            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,

                        510K, etc.)

                    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

Please complete this inquiry form to receive additional information.