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Clinical Operations

We provide comprehensive clinical support for global Phase I-IV studies from start‑up to close‑out. Our cross-functional team of scientific and clinical operations experts will work with you and your strategic partners to anticipate and meet any challenges of complex program design, clinical trial conduct, and regulatory approval.

Support services are customizable and can include:

  • Project management

  • Project feasibility/clinical trial design

  • Clinical site selection

  • Study start-up (including ethics submissions oversight, SIV, IM, contract negotiations)

  • Subject recruitment

  • Continuous clinical site training, management, and monitoring

  • Database set-up and maintenance

  • Medical monitoring

  • Risk management

  • Medical writing

  • Local & global safety reporting

  • Management of third party vendors

  • Clinical site/trial closeout

  • TMF management and transfer


Contact us to talk to a clinical operations and project management expert about your development program.

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