WORK PRODUCT

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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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