SMO-Pharmina

What SMO-Pharmina does

SMO-Pharmina is a privately-held site management organization (SMO) headquartered in Tbilisi, Georgia, that delivers integrated clinical trial site-management services to pharmaceutical sponsors and Contract Research Organizations (CROs) conducting trials in Georgia and the Caucasus. Founded in 2006 and operating as SMO-Pharmina Ltd (a Georgian limited liability company), the firm has built what it describes as the leading SMO position in the country, supporting Phase I-IV trials, bioequivalence studies, and medical device studies across all therapeutic areas. Cumulative operating metrics cited include 80-115+ clinical trials managed, 3,900+ patients enrolled, 260 partner sites, 255 investigators, and 130-155+ audits conducted over approximately 15 years.

The company's service portfolio comprises eight integrated lines delivered as a one-stop platform: Site Management, Project Management, Monitoring, Study Coordinators, Clinical Laboratory, Pharmaceutical Warehouse, Independent Audit, and a Training Center. The technical backbone is an ISO 9001:2015-certified quality management system (held continuously since 2008, audited annually by TÜV SÜD), GCP-compliant site operations, and a multi-temperature pharmaceutical warehouse operating under GDP/GSP standards with storage bands at 15-25°C, 2-8°C, -20°C, -45°C, and -80°C. The in-house clinical laboratory performs hematological, biochemical, immunological, and coagulation testing with external interlaboratory quality-control participation. Two managed sites have passed FDA inspections without Form 483 issuance. The Training Center delivers ICH E6 (R2)-aligned GCP training recognized by TransCelerate BioPharma for mutual recognition among sponsors, plus study-specific training.

SMO-Pharmina generates revenue through professional-services fees charged to international sponsors and CROs under direct B2B contracts — service pricing is not publicly disclosed and is negotiated per trial based on scope, duration, and service requirements. The go-to-market is sales-led direct engagement, supported by a multilingual website (English, Georgian, Russian). The core customer segments are pharmaceutical/biotech sponsors and CROs, with 260 Georgian clinical-trial sites acting as delivery partners rather than paying customers. The firm operates with 11-50 employees, has no parent company, no disclosed institutional ownership, no funding rounds, and no subsidiaries.

Name

SMO-Pharmina

Legal name

SMO-Pharmina Ltd

Website

https://smo-pharmina.net

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

SMO-Pharmina is a privately-held Georgian site management organization providing integrated clinical trial services — site management, monitoring, laboratory, pharmaceutical warehousing, audit, and GCP training — to pharmaceutical sponsors and CROs running trials in Georgia.

Ownership category

akta.pro rank

Product category

Clinical Trial Site Management Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Management Services (8741)

akta.pro primary industry

Site Network Operators & SMOs (HLAGACAA)

akta.pro secondary industries

Clinical Trial Site Operations & Study Coordination (HLAGACAE), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Clinical Trial Pharmacy & IMP Management at Site (HLAGACAK), Site Quality Management & Audit Readiness (HLAGACAN)

Keywords

• Clinical trial site management
• Pharmaceutical warehousing services
• GCP training programs
• Clinical research services
• Site management organization

Headquarters

HQ city

Tbilisi

HQ country

Georgia

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Clinical Trial Site Management Services: Comprehensive professional services for clinical trials including site management, project management, monitoring, study coordination, regulatory affairs, and quality assurance. Revenue generated through service fees charged to sponsors and CROs for managing clinical trial sites in Georgia.
2. Laboratory Testing Services: Clinical laboratory services for trials including hematological, biochemical, immunological, and coagulation tests. Charges for test processing and kit preparation.
3. Pharmaceutical Storage and Logistics: Temperature-controlled storage and distribution of investigational products under GDP/GSP compliance. Revenue from warehousing and logistics services for clinical trial materials.
4. GCP Training Services: Training programs for clinical trial personnel including GCP certification and study-specific training. Provides international certificates upon completion.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

SMO-Pharmina is a site management organization (SMO) based in Georgia that provides identification and recruitment of clinical trial sites, investigators, and patients for pharmaceutical sponsors and CROs. It delivers end-to-end clinical trial management including site management, project management, monitoring, study coordination, clinical laboratory testing, temperature-controlled pharmaceutical warehousing, independent GCP/GDP audits, and GCP training programs. Services are delivered through a network of 260 partner clinical trial sites across all therapeutic areas in Georgia.

Product overview

SMO-Pharmina operates as a unified Site Management Organization providing end-to-end clinical trial management services in Georgia. The portfolio consists of eight integrated service lines: Site Management (ensuring GCP compliance and patient recruitment), Project Management (full trial lifecycle oversight), Monitoring (regulatory liaison and site monitoring), Study Coordinators (medical-staffed site support), Clinical Laboratory (diagnostic testing), Pharmaceutical Warehouse (temperature-controlled storage/distribution), Independent Audit (GCP/GDP auditing), and Training Center (GCP and study-specific training). The Training Center encompasses two sub-products—GCP Training (ICH E6 R2 aligned, TransCelerate-recognized) and Study-Specific Training—delivered in Georgian by certified trainers. The services function as an integrated ecosystem supporting Phase I-IV trials, bioequivalence, and medical device studies across 11 therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Site Management (კლევითი ცენტრების მენეჯმენტი) Comprehensive management of clinical trial sites ensuring protocol compliance, GCP guidance, rapid startup, patient recruitment, and accurate documentation. Targeted at pharmaceutical sponsors and CROs conducting trials in Georgia.
• Project Management (პროექტების მართვა) Full project lifecycle management including contract negotiation, budget planning, regulatory documentation, site activation, GCP training, internal monitoring, and project closure. Targeted at pharmaceutical sponsors and CROs.
• Monitoring (მონიტორინგი) Clinical trial site monitoring for Phase I-IV trials, medical device studies, and bioequivalence studies with regulatory agency liaison. Targeted at pharmaceutical sponsors and CROs.
• Study Coordinators (კლევის კოორდინატორი) Qualified coordinators with medical education supporting study teams in patient visits, CRF completion, site file updates, IP management, and biological sample handling. Targeted at clinical trial sites and sponsors.
• Clinical Laboratory (კლინიკური ლაბორატორია) Regional laboratory services for hematological, biochemical, immunological, and coagulation testing with external and internal quality control. Targeted at clinical trial sites and pharmaceutical sponsors.
• Pharmaceutical Warehouse (ფარმაცევტული საწყობი) Temperature-controlled storage (15-25°C, 2-8°C, -20°C, -45°C, -80°C) and distribution of investigational products with GSP and GDP compliance. Targeted at pharmaceutical sponsors and CROs.
• Independent Audit (აუდიტი) GCP and GDP audit services for clinical trial sites and logistics companies with certified Georgian auditors knowledgeable in local regulations. Targeted at pharmaceutical sponsors and CROs.
• Training Center (სასწავლო ცენტრი) GCP and protocol-specific training programs for clinical trial teams, recognized by Georgian Ministry of Labor, Health and Social Affairs and meeting TransCelerate BioPharma mutual recognition criteria. Targeted at clinical trial investigators and staff.

Quantifiable outcome

• 80+ clinical trials conducted successfully with 3,900+ patients enrolled
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Partner Clinical Trial Sites (260 sites)coreStrategic or Co-development PartnerSMO-Pharmina has established a network of 260 GCP-compliant clinical trial sites across Georgia covering all therapeutic areas including oncology, neurology, infectious diseases, internal medicine, surgery, and more. These partner sites enable the company to provide comprehensive site management services to sponsors and CROs.
• 255 InvestigatorscoreStrategic or Co-development PartnerNetwork of 255 trained investigators working at partner clinical trial sites across Georgia. These investigators have medical education, experience in clinical trials, and are GCP-trained, enabling high-quality trial conduct.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Cromos Pharma: US-founded CRO with deep operational footprint in Central/Eastern Europe and the CIS, including Georgia. Like SMO-Pharmina, Cromos positions itself as a regional bridge for sponsors seeking faster patient recruitment and lower-cost trial execution outside Western Europe and North America.
• PSI CRO: Global CRO with strong Eastern European and CIS operations and dedicated SMO/site-management capabilities. PSI is one of the most direct competitors for regional trial placement work and partner-site coordination in geographies like Georgia.
• OCT Clinical Trials: Russia-headquartered CRO operating across Eastern Europe and the CIS, offering site management, monitoring and regulatory services. Directly comparable regional model to SMO-Pharmina, though it serves a larger Russia-anchored footprint.

Broad incumbents

• IQVIA: World's largest CRO with end-to-end clinical operations, SMO networks and laboratory services. IQVIA competes indirectly in Georgia via global sponsor master agreements and represents both the dominant incumbent and a potential channel partner for SMO-Pharmina.
• Charles River Laboratories: Major CRO/CDMO with broad discovery-through-clinical services including site management and biopharma partnerships. While more diversified than SMO-Pharmina, it competes for sponsor trial outsourcing budget across global geographies.
• Medpace: Mid-to-large global CRO focused on small and mid-sized biopharma sponsors, with full-service clinical operations. Comparable business model overlap on the trial-management side, though Medpace operates at significantly larger scale.
• ICON plc: Top-3 global CRO following its PRA Health Sciences acquisition, offering full-service clinical development including site management and lab services. ICON's sponsor relationships and global trial pipeline overlap with the same customers SMO-Pharmina serves.
• Syneos Health: Large global biopharmaceutical solutions organization combining CRO and commercial services. Operates clinical trial site networks across multiple geographies and competes for the same sponsor outsourcing dollars that flow to regional SMOs.
• Worldwide Clinical Trials: Mid-sized global CRO offering clinical development and site management across multiple therapeutic areas. Similar sponsor profile and operational model, with comparable Phase I–IV trial focus.
• Parexel: Global CRO with broad clinical operations, regulatory consulting and site management services. Targets the same pharmaceutical sponsor base and competes for trial placement in emerging markets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks4 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/smo-pharmina

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SMO-Pharmina