Clinical Operations Services

Pharmaceutical consulting support and clinical trial management providing coordination for pharmaceutical clients
with investigators, contract research organizations, contract manufacturers and packagers from project start through completion.

Success built on a solid foundation assuring GxP compliance for Phase I through IV clinical studies.

Services include Project Management and Clinical Trial Management support for:

  • Interim management and collaboration with CROs, CMOs, clinical investigators and partners
  • Development of study start-up materials, case report form and EDC design, IVRS design, study drug planning, Investigator site training
  • Coordinate clinical and operational activities in the planning and execution of a project.
  • Contract negotiations for outsourced services (Sponsor and CRO Side Bid Defense)
  • Data collection design and review
  • Update key stakeholders and global team on study status, progress, timelines, risks, and contingency plans,
    including weekly updates to trial management systems, monthly reporting to management, and annual safety updates.
  • Negotiations for comparator drug procurement
  • Double-blind design, packaging and labeling oversight
  • Study drug logistics and reconciliation
  • Co-monitoring of clinical study sites and laboratories
  • Protocol writing and review
  • Inspection Readiness
  • Double-blind design, packaging and labeling oversight
  • Contribute to preparation of CTD (ICH Common Technical Document)