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Services

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

Site management

  • Translation and cultural adaptation of essential and other clinical study documentation
  • Investigators’ meeting organization
  • Site administration
  • Principle investigators’ and site contracts and payments

Project management

  • Global and regional project management
  • Vendor management
  • Central laboratory, Central Imaging Review, Central ECG Review, QP release, EudraVigilance, others

Clinical trial monitoring

  • Phase I, Phase II-III, Phase IV/Post approvalBA/BE studies, PK studies
  • BA/BE studies, PK studies
    for novel biopharmaceuticals, medical devices, combination products, generics, biosimilars and biologics

Clinical trial logistics & warehousing

  • Study drug import
  • Biological samples export
  • Clinical study materials’ distribution to the investigative
  • GCP and FDA compliant warehousing in Russia
    Ambient, refrigerated and frozen, See warehouse and logistics services for details

Quality assurance and quality control

  • Independent audits
  • Inspection readiness for sites
  • Vendor / facilities audits

Safety management

  • Local SAE management and medical monitoring
  • 24/7 Hotline
  • Data and Safety Monitoring Board

Data management and biostatistics

  • Clinical data management
    Using EDC and paper CRF, EDC training to the investigator sites, Database design and clinical programming, data management, query resolution and table listing
  • Bio-statistics & SAS programming
    Protocol and SAP development, Sample size estimation, Data derivation and mapping to CDISC standards, Output generation and analysis, Interpretation of results and input to Clinical Study Reports

Scientific & medical writing

  • Medical writing
    Clinical study synopsis, Protocol, IB, ICF, CRF design, Patient Information Sheet (PIS) and Quality of Life (QOL) Questionnaire
  • Regulatory writing
    Interim and final clinical study reports (CSR), Subject Narratives Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries, expert reports, safety & efficacy summaries; Aggregate safety reports such as Periodic Safety Update Reports (PSURs), bridging reports, Periodic Adverse Drug Experience Reports (PADER), Annual safety reports (ASR)s; policy papers.
  • Scientific writing
    Editorials, posters, Package Inserts (prescribing information), Product literature, Health economics and outcome research (HEOR) related reports and research papers

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