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Aerial View of Waves



Develop a Clinical Strategy and Plan

Prepare and lead Clinical Advisory Board meetings

Produce, QC and support  Pre-IND/Pre-Submissions

Identify investigational sites, vendors and advisory team members

Prepare budget and oversee contract process with vendors and investigational sites

Prepare IRB/IEC submissions

Conduct Studies(Phase I through Phase IV)

  • Protocol design and Protocol writing

  • Scientific consultation when appropriate

  • Onsite or Remote Clinical monitoring

    • Review of inclusion exclusion criteria and the proper consenting of all subjects

    • Site selection and qualification visits

    • Assist with obtaining approval from local Ethics Committees and Institutional Review Boards

    • Review of quality systems at the site and ensuring all sites are audit ready

    • Initiation, interim monitoring, and study closure visits

    • Essential document collection, review and processing

    • Good Clinical Practice monitoring, including motivational and training visits

    • CAPA plan development and implementation

    • Source documentation review, Source Document Verification, CRF review and queryresolution

    • Accountability for all study documents and materials

    • Communication with sites

    • Study specific training for site personnel

    • Review of Investigational Product accountability and storage

    • Review of safety information of all subjects

    • Logging and correcting protocol deviations

    • Monitoring study progress

    • Database lock and study close out

  • Mass mailings and newsletters to sites Provide On-going Clinical Support update

  • Attend team meeting

  • Advise on clinical topics

  • Attend meetings with Pharma partners

  • Produce regulatory/clinical materials for investigator or business development presentations

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