Helping Companies Reach Compliance Goals Since 2005

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Clinical QA

equipmentTicalion provides world-class GCP Quality Assurance services to Sponsor Organizations, Investigator Sites, Clinical Trial Facilities and Clinical Management Organizations that need to meet FDA compliance requirements.Clients count on our deep understanding of the industry as well as its ever-changing policies and business landscape to design and commission GCP Quality Management Systems that improve their current status and meet FDA regulations.Our special areas of competence include:  Biologics, Recombinant products, Vaccines and other parenteral products (antibody, chemical etc), and medical devices.Ticalion’s GCP subject matter experts perform Clinical Quality Assurance management and oversight of Pre-Clinical, Phase I, Phase II and Phase III Clinical Trials including:

  • Protocol review and Clinical Quality Assurance section development
  • Compliance review of Essential Documents
  • Vendor and Subcontractor qualification
  • Quality Assurance oversight of clinical trial startup including IP release
  • Validation of the clinical trial database including development of validation protocols and test protocols
  • Software and computer system validation for ancillary devices such as data entry portals
  • Clinical Quality Assurance Auditing of Investigator Sites | CROs | Laboratories| Manufacturers| Intermediaries and Subcontractors
  • Clinical Quality Assurance Auditing of study data and records including:
  • Trial Master File
  • Site Master File
  • Investigational Product (IP) accountability
  • Tables, Listings and Figures
  • Clinical Study Report

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About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.