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.

1. Study Start-up Services:

   Services designed to support effective clinical trial study design, financial modeling and sustainability, and streamlined study activation.

   1. Clinical Trial Protocol Design
      1. Protocol development and study design
      2. Statistical relevancy and study enrollment targets
   2. Clinical Trial Budget Development Services
      1. Medicare Coverage Analysis
      2. Certified Procedural Coding & Research Pricing
      3. Budget development and negotiation
      4. Sponsor and/or participating site invoice management
      5. Account forensics and/or reconciliation
   3. Study Activation Services
      1. IRB application preparation and/or submission
      2. Informed subject consent development
      3. Study activation facilitation at UCLA (as an enrollment center)
2. Regulatory Support Services: 

   Services designed to support key regulatory requirements related to the performance of clinical research studies in the United States.

   1. FDA Guidance & Application Support Services
      1. Development and/or review of FDA Drug and/or Medical Device Applications (e.g. IND, IDE, 510K, etc.)
      2. General FDA Consultative Support Services
   2. Scientific Review & Regulatory Affairs
      1. Data Safety Monitoring Board
      2. Scientific Review
      3. Regulatory and source data monitoring and auditing
3. Study Coordination Services

   Services designed to facilitate subject recruitment and active clinical trial coordination efforts.

   1. Single-Center Clinical Trial Coordination Service
      1. Participant recruitment and/or marketing efforts
      2. Participant pre-screening
      3. Study coordination
   2. Multi-Center Clinical Trial Coordination
      1. Site feasibility and site selection
      2. Study activation coordination
      3. Clinical Trial Contracting
   3. Central Laboratory Services
      1. Central lab processing, resulting and storage
      2. Mitigates vaiances in lab norms and performance
4. 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.

   1. Clinical Research Training and Certification

      1. Clinical Research Coordinator Certification
      2. Clinical Research Financial Management Certification

Please complete this inquiry form to receive additional information.