Related Services

Medical Writing for SOPs, Procedures, Patient Narratives, Etc.

Development/ Review/ Revision of Standard Operating Procedures – Areas of writing services include, but not limited to clinical operations, project management, monitoring, data entry, data management, biostatistics, medical writing, quality assurance (QA), drug safety and pharmacovigilance.

Project Management

  • Workflow Analysis (consultation)
  • Design and implementation of clinical Project Workflow/Timelines (project management)

Clinical Monitoring Services

  • Pre-study monitoring plan development
  • Clinical site prequalification
  • Clinical site initiation
  • Interim site visits; ongoing data verification, test article accountability, and study file monitoring
  • Study-site closeout visits
  • In-house prospective and retrospective clinical study data collection and CRF completion
  • Data integrity

Regulatory Compliance Services

  • Development/ Review/ Revision of Standard Operating Procedures
  • Development of FDA IND Safety Updates
  • Development of NDA/ PLA/IND, BLA, IDE, PMA, and 510K Submissions/ Updates
  • Review of labeling, marketing materials and packaging

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