Clinical Operations

With decades of experience on both the sponsor and CRO sides of drug development, our clinical operations team functions proactively by anticipating needs and designing solutions for every potential challenge. Our approach ensures trials progress in adherence to timelines and budgets while always maintaining high quality and data integrity. 


Services include:

  • Clinical Trial Management

  • Site/Investigator Identification & Qualification

  • Study Start-up (including site & vendor selection and set-up)

  • Investigator Meetings & Site Training

  • Contract and Budget Negotiation

  • EDC set-up and management

  • Study Monitoring

  • Site Management & Patient Recruitment

  • Investigational Product Management

  • Trial Master File Management

  • Study Specific Plan(s) Development

  • Clinical Document Development (Protocol, ICF, IB)

  • Source Document Development

  • Vendor Management (Laboratory, EDC, IWRS)