Global Clinical Trials (GCT)

Global Clinical Trials (GCT) is a premium contract-research organization (CRO) supporting Phase I-IV clinical studies and post-marketing activities for international and local Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions.

The GCT team now consists of over 100 full-time clinical research professionals. They guarantee a tailored approach for every project and provide their clients with both standalone services as a functional service provider (FSP) and excellent full-service support during study start-up, active project phase and study close-out. They stay fully compliant with the latest GCP, EMA and FDA guidelines, and local regulations.

GCT has been a reliable partner for many local and international pharmaceutical and medical device companies. Their professional staff have been sharing their unique experience and utilizing established contacts with the KOLs. They have their Quality Management System based on the internally developed Standard Operational Procedures (SOP) and have successfully passed more than 65 regulatory inspections and external audits, including the ones by U.S. Food and Drug Administration (FDA).

Clinical Research Services

GCT is a full-service CRO. Whether you are looking for a complete end-to-end solution for a global study, or need enrollment rescue to get your ongoing project back on track, or seeking one of our local stand-alone services — you have come to the right place

Study start-up

  • Feasibility Analysis and Site Selection
  • Study-Specific Trainings
  • Kick-Off and Investigators' Meeting

Site Management

  • Site Contracting and Payments
  • Site Start-up and Training
  • Ad-Hoc Communication
  • Subject Enrollment Oversight
  • Query Resolution

Project Management

  • Essential Project Plans
  • Clinical Trial Supervision
  • Time Tracking and Status Reporting
  • Budget Management
  • Timeline Management
  • Risk Management
  • Team Coordination

Clinical Trial Monitoring

  • Monitoring Plan
  • Site Qualification Visits
  • Site Initiation Visits
  • Risk Based Monitoring
  • Centralized Monitoring
  • Routine On-site monitoring
  • Unblinded monitoring
  • Close-out visits

Clinical Trial Logistics & Warehousing

  • Investigational Product Logistics
  • Comparator/Rescue medication Logistics
  • Ancillary Supplies and Equipment Logistics
  • Biosamples logistics
  • GCT Warehouse facility in Russia

Quality Assurance and Quality Control

  • Quality Plan
  • Audit Plan
  • Site audit
  • Vendor audit
  • SOP system
  • Quality Management System (QMS) audit
  • Trial Master File (TMF) audit
  • Standard Operating Procedures (SOP) Development
  • CAPA Development and Implementation

Safety Management Plan

  • Safety Database
  • AE/SAE Management
  • Narrative Writing
  • Safety Reporting
  • Periodic Reporting (DSUR/PSUR) to Regulatory Authorities and Investigational Sites
  • Signal Management
  • Device Vigilance
  • Data Safety Monitoring Board

Data Management and Biostatistics

  • Data Management/Validation Plan
  • CRF/eCRF Design
  • Database Development
  • Medical Coding Terms using MedDRA and WHO Drug
  • Discrepancy Management
  • Database Lock and Archival
  • External Data Transfer, Reconciliation and Integrations
  • Data Management/Validation Report
  • Biostatistics
  • Statistical Analysis Plan (SAP)
  • Sample Size Calculation
  • Randomization

About Clinical Trials Innovation Programme

Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.

Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.

We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.

Register with us to learn more!