A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Clinical Operations

InClin provides clinical operations services that cover Phase 1 to 4 clinical research activities. With offices in North America and Australia, InClin’s experienced clinical operations team has broad expertise across multiple therapeutic areas.

PROJECT MANAGEMENT

InClin utilizes trained project management professionals with a direct, hands-on approach to oversee all aspects of your study, assuring that your trial will be of the utmost priority. Project Management processes are standardized and optimized through our established Project Management Office (PMO). Our PMO is managed by a PMP-certified project manager and Project Management Institute’s (PMI’s) principles are used to manage our studies; in particular we ensure that the triple constraint of time, budget, and scope are closely monitored to provide quality, on-time and within budget results. In addition, InClin provides Project Director oversight throughout the life of the project.

PROJECT PLANNING

  • Timeline Optimization
  • Country Selection
  • Feasibility and Investigator Selection
  • Study Start Up
  • Study Execution
  • Vendor Selection and Management
  • Dedicated Teams for Key Functions
    • Global oversight
    • Drug supply chain and pharmacy management (unblinded)
    • Efficacy endpoints (eg Microbiology, Imaging, Biomarker, etc.)

CLINICAL MONITORING AND SITE MANAGEMENT

InClin hires only senior level Clinical Research Associates (CRAs) with at least 5 years’ experience. On average, our CRAs have over 7 years’ experience in multiple indications. The majority of our monitors are regionally based to reduce travel time to sites.

  • Phase 1 through 4 monitoring
    • North America
    • Australia
    • Global reach through trusted regional partners

FEASIBILITY

We facilitate site selection driven by site relationships and performance and knowledge of regional/country regulatory processes. Our feasibility assessment provides the following information:
Site Team Experience

  • Patient population and access
  • Realistic enrollment expectations
  • Site staff experience and resources to execute the trial
  • Site infrastructure to execute study
  • Site Staff interested in the study
  • Involvement in competing studies
  • Site specific patient flow and enrollment plans
  • Contract, Budget and Ethics process and timing

TRIAL MASTER FILE

InClin can manage your Trial Master File (TMF) on paper or electronically.

InClin offers the leading cloud-based system, Veeva Vault.  It is an integrated long-term solution that creates an audit-ready, quality-driven eTMF in a paperless environment, providing operational efficiencies and complete visibility to our clients.

Our eTMF solution provides clients:

  • Greater operational efficiency
  • Improved client visibility and reporting
  • Easy, web-based access for all parties