Global Clinical Trials, LLC (GCT) was founded in 2001 by Jeffrey T. Apter, MD and Eugene Selivra, MD, both key opinion leaders in the CNS field with backgrounds in pharmaceutical industry operations. The company is headquartered in Princeton, New Jersey, USA, and operates through 12 international offices with coverage spanning the United States, Western Europe, Central and Eastern Europe, and Asia.

GCT positions itself as a premium full-service CRO serving Phase I through Phase IV clinical studies and post-marketing activities, with the flexibility to operate as either a full-service partner or a functional service provider on a standalone basis. The company serves a broad client base ranging from global pharmaceutical companies — including several in the top 10 by revenue — to small and medium-sized biotechs, academic institutions, and investment groups. Over 25 years of operation, GCT has completed more than 400 clinical trials worldwide and maintained a database of over 5,000 investigational sites and KOL contacts. The company has passed more than 90 external project and system audits, including regulatory inspections by the US FDA and local health authorities in Russia and Ukraine.

A notable operational asset is GCT’s 400 sq. m. GMP-compliant drug storage and distribution facility in St. Petersburg, Russia, which supports ambient, climate-controlled, refrigerated, and frozen storage, along with investigational product packaging, labelling, and biosample management. GCT’s geographic coverage is particularly deep across Central and Eastern Europe, with active offices and established site networks in Hungary, Poland, Czech Republic, Slovakia, Romania, Bulgaria, Moldova, Georgia, Kazakhstan, Ukraine, and Russia, alongside India and China. The company expanded into Austria in 2025–2026.

Key Products and Services

Study Start-Up

• Feasibility analysis and site selection, study-specific trainings, kick-off and investigators’ meetings

Regulatory Affairs

• Clinical trial approval (CTA) submissions across all covered markets; US FDA regulatory support; Ethics Committee and IRB support; import and export licence management; orphan drug designation applications to EMA and FDA; translations and adaptations; amendment and notification submissions; regulatory consulting; clinical trial insurance management; EU Legal Representation; drug and device registration and marketing authorisation support, including CE marking

Scientific and Medical Writing

• Protocol design and clinical study design, clinical study protocol (CSP), informed consent form (ICF), investigational brochure (IB), clinical study report (CSR), literature screening, and scientific advisory services

Project Management

• Full project supervision including essential project plans, budget and timeline management, risk management, and team coordination

Clinical Trial Monitoring

• Monitoring plan development, site qualification and initiation visits, risk-based and centralised monitoring, routine on-site monitoring, unblinded monitoring, and close-out visits

Site Management

• Site contracting and payments, site start-up and training, subject enrolment oversight, and query resolution

Patient Recruitment

• Recruitment planning, materials and advertising, referral activities, booster visits, patient reimbursement, and telemedicine-supported recruitment

Data Management and Biostatistics

• eCRF design, database development, medical coding (MedDRA and WHO Drug), discrepancy management, database lock, external data transfers and reconciliation, CDISC compliance (SDTM, ADaM), statistical analysis plans (SAP), sample size calculations, randomisation schedule development, and interim and final statistical reporting

Safety Management

• Adverse event and SAE management, safety database management, narrative writing, periodic reporting (DSUR/PSUR), signal management, device vigilance, and DSMB support

Quality Assurance and Quality Control

• Quality and audit planning, site and vendor audits, SOP system development and maintenance, QMS and TMF audits, and CAPA development and implementation

Vendor and Logistics Management

• Central and specialty laboratory management, central imaging and spirometry management, rater services, investigational product and biosample logistics, and ancillary supplies management via in-house warehouse facility

Technology and Software

• CTMS, eTMF, EDC, ePRO, eCOA, IRT/IWRS, eRegulatory, and eSource system selection and management

Regulatory and Legal Services

• EU Legal Representation for non-EU sponsors; GDPR representation and data protection officer (DPO) services

GCT occupies a well-defined niche as a mid-size CRO with particular operational strength in Central and Eastern Europe, a region characterised by motivated investigator networks, treatment-naive patient populations, regulatory environments largely aligned with ICH-GCP and EU standards, and cost structures that are competitive relative to Western European comparators. Its combination of a Princeton-based US headquarters, 12 international offices, and in-house warehousing in Russia provides a degree of operational infrastructure that larger sponsors conducting multi-regional studies in these geographies will find practically useful. The company’s founding by CNS-specialist clinicians is reflected in a historical therapeutic focus on neurology and psychiatry, though its current portfolio extends across oncology, cardiovascular, ophthalmology, and other areas. With over 25 years of operation, a strong repeat-business rate, and a track record across more than 400 trials, GCT represents a credible, regionally grounded alternative to larger global CROs for sponsors whose trial footprint includes Eastern European, Central Asian, or South Asian markets.