«Путь стартапа» — как в Грузии удаётся обеспечить предсказуемые сроки запуска пробных версий в течение 6–8 недель
GeoStorage LTD.
3 мин чтение
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Executive Overview
In clinical research, site activation speed is critical. Standard trial startup timelines across Western Europe and North America frequently stretch to 4–6 months, bottlenecked by multi-layered regulatory boards, complex local ethics panels, and drawn-out contract negotiations.
Georgia’s unified clinical start-up pathway removes these structural bottlenecks. By combining a single regulatory/ethics application model, standardized site contracts, and pre-vetted site infrastructure, Georgia enables sponsors to transition from dossier submission to First Patient In (FPI) within 6 to 8 weeks.
1. The Single-Window Approval Model
The primary driver of Georgia’s rapid start-up is its parallel, centralized regulatory and ethics framework. Article1_Chart2.png144.93 KB
Parallel Processing: The National Competence Authority (LEPL Agency for State Regulation of Medical Activities) and the Central Ethics Committee (IRB) review applications simultaneously rather than sequentially.
Aggressive Review Timelines: Regulatory review and approval are completed within 10 to 14 business days from submission.
Simplified Dossier Requirements: Georgia accepts standard EU/US CTD-formatted dossiers, minimizing the need for region-specific rewrites or extensive local adaptations.
2. Institutional Readiness & Contract Execution
Regulatory approval is often delayed by site-level contract negotiations (CTA) and Budgeting. Georgia eliminates these delays through pre-structured site governance: Table3_2x.png131.18 KB
Centralized Site Networks: Major clinical centers in Tbilisi, Kutaisi, and Batumi maintain dedicated trial management units (CTUs) that execute budgets concurrently with the regulatory submission.
3. Integrated Logistics & Import Clearance
Fast-Track Import Licenses: Issued automatically upon trial regulatory clearance.
Expedited Customs Clearance: Clinical supplies, laboratory kits, and temperature-sensitive IMPs clear customs within 24 to 48 hours at Tbilisi International Airport (TBS) through GeoStorage’s Importer of Record (IOR) and local customs brokerage protocols.
Unbroken Cold-Chain Infrastructure: GeoStorage provides end-to-end GDP-compliant depot storage (+2C to +8C, +15C to +25C, -20C to -35C, -86C to -197C (deep freeze options)) with active temperature monitoring from runway pickup to site delivery.
4. GeoStorage - The On-the-Ground Partner for Fast-Track Activation
While Georgia's regulatory framework allows rapid approval, execution depends on local operational capability. GeoStorage serves as the single-point operational bridge for international CROs and sponsors:
Importer of Record (IOR) & Regulatory Representation: Managing local import authorizations, tax exemptions, and customs documentation ahead of time so shipment clearance occurs in 24–48 hours.
Depot & Clinical Supply Chain Management: Strategic warehousing in Tbilisi offering GDP-certified storage, additional labelling (in Georgian/English), and emergency local batch safety stock.
Last-Mile Clinical Distribution: Temperature-validated logistics to trial sites in Tbilisi, Kutaisi, and Batumi with real-time temperature loggers and same-day delivery options.
Biological Sample Export Handling: Turnkey coordination of patient sample collection, biospecimen packaging, and export logistics to central European laboratories.
Direct-to-Patient (DTP) delivery services for clinical trials. Delivering Investigational Medicinal Products (IMPs) and clinical supplies directly to patients' homes across Georgia and beyond.
Phase
Standard Global Model
Georgia Pathway
GeoStorage Operational Role
Ethics & Regulatory
8–12 Weeks
2–3 Weeks
Local regulatory representation & documentation alignment
