CLINICAL SERVICES

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

LANDRICH GROUP

Clinical, Quality, and Regulatory consulting services to Medical Devices, IVD, and Pharmaceutical clients.

CONTACT

2532 Santa Clara Ave Suite 344, Alameda, CA 94501