EESD GROUP
Contract Research Organization · Ukraine

Ukraine-First🇺🇦 ClinicalResearchDelivery🧬 Platformfor🇪🇺 EuropeanSponsors

One accountable interface. Senior delivery team. Full clinical execution from study design to final report.

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Clinical OperationsRegulatory AffairsBiometricsMedical WritingDigital Oversight
Why ESD GROUP

Why ESD GROUP

Six reasons European sponsors choose us for clinical execution in Ukraine

UKRAINE ADVANTAGE

Operational advantages of Ukraine

  • Centralised healthcare structure supports broad patient recruitment
  • Well-trained investigators and healthcare professionals
  • More accessible regulatory path for selected programme types
  • Operational efficiency vs. selected EU markets
ONE INTERFACE

Single accountable interface

  • One governance and escalation point for the sponsor
  • Clear visibility into startup, monitoring and data status
  • Reliable regulatory navigation and document discipline
  • No coordination gaps between disconnected vendors
SENIOR TEAM DEPTH

Medically grounded leadership

  • MD-level clinical and regulatory leadership
  • Oncology, hepatology, cardiology background
  • Delivery leads remain close to execution
  • Phase I–IV experience, operational focus on II–IV
DIGITAL TRANSPARENCY

Sponsor-facing digital visibility

  • Sponsor-level visibility: initiation, CRF progress, data flow
  • EDC backbone — 21 CFR Part 11-oriented control logic
  • Dashboard oversight without over-management
  • Remote monitoring and tracked changes with reasons
CROSS-FUNCTIONAL DELIVERY

Integrated delivery pipeline

  • Clinical ops + Regulatory + Biometrics + Writing
  • Integrated — not handoffs between disconnected vendors
  • From protocol to final report — one coordinated structure
  • Senior leads remain close to execution
EUROPEAN EXTENSION

Scalable to Europe

  • Ukraine-first, extendable through partner coverage when required
  • Flexible country strategy without changing governance logic
  • Public footprint: Ukraine, Poland, broader EU
  • Sponsor geographies: DE, FR, NL, KR, IL, US
Services

End-to-End Services

Nine service zones. One sponsor-facing delivery structure.

01
Study Design & Protocol
Feasibility, protocol development, amendments, CIP, ICF/PIL/IB
02
Regulatory & Ethics
Country strategy, dossier preparation, EC/LEC submissions, local filing, import/export
03
Site Feasibility & Startup
Site identification, qualification, investigator training, TMF setup, recruitment support
04
Contracts & Vendors
Contract flow, vendor management, logistics, customs documentation, payment coordination
05
Monitoring & Medical Oversight
Site initiation/monitoring/close-out, SDV, medical monitoring, audit preparation
06
EDC / Database / Cleaning
DMP/DVP, database structure, EDC configuration/validation, edit checks, coding, soft/hard lock
07
Biostatistics
Sample size, SAP, interim/final statistical reports, SAS/R/CDISC standards
08
Medical Writing & CSR
Protocols, amendments, CRF, SAE narratives, CSR, IB, ICF/PIL
09
Archive & Closeout
TMF control, closeout visits, archiving, final documentation, records management
Medicinal ProductsMedical DevicesIVDNon-Interventional StudiesRegistries
Track Record

Track Record

Operational pedigree behind the ESD GROUP delivery platform

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Selected Oncology Programmes

ProgrammePhase / DesignProductGeography
Relapsed Hodgkin lymphomaPhase IV / RWEMedicinalJapan
Advanced prostate carcinomaPhase II / multicenter comparativeMedicinalCanada
Stage III–IV melanomaObservational / retrospective RWEOtherUkraine
HR+/HER2− early breast cancerPhase III / randomizedMedicinalGermany
Inoperable stage III–IV NSCLCPivotal / device-combination pilotMedical deviceUkraine
Gyneco-oncology / AUB programmePhase III / comparativeMedicinalCanada

Other Therapeutic Areas

ProgrammePatientsSitesGeography
Hepatitis C1,45018Ukraine, Latvia, Lithuania, Estonia
Non-alcoholic fatty liver disease1,10050Ukraine
Diabetes89040Poland
Juvenile Rheumatoid Arthritis45032Ukraine, Belarus
Acute Pyelonephritis41628Multi-country CEE/CIS
Pancreatitis22016Poland, Kazakhstan
Digital Oversight & Quality

Digital Oversight & Quality

Technology backbone and compliance model that sponsors can rely on

Site Input
EDC
Central Cleaning
PM Dashboard
Sponsor

Digital Oversight

EDC Backbone

  • Initiation and CRF progress visible online
  • Remote site initiation capability
  • Validation before save + tracked changes with reasons
  • User authorisation, session limits, activity logging
  • 21 CFR Part 11-oriented control logic

Data Flow

  • Site Input → EDC → Central review / cleaning
  • PM Dashboard → Sponsor Overview
  • Remote monitoring module
  • Support for trials, observational studies, registries

Quality & Compliance

Standards

  • ICH-GCP (E6 R3)
  • ISO 14155 awareness (medical devices)
  • GCDMP-aligned data practices
  • 21 CFR Part 11 EDC control logic

Process Governance

  • SOP-driven execution + stage approvals
  • CAPA / nonconformity handling
  • Documentation management + risk assessment

Information Protection

  • DPO leadership
  • Data protection + access control
  • Information security protocols
Team

Team

Senior expertise across every delivery function

Clinical Governance & Quality Lead
  • MD / anesthesiology background
  • Prior leadership: Sanofi/Aventis, Medicore, Amaxa
  • DPO and internal audit responsibilities
  • Reduces governance and escalation risk
Clinical Delivery Lead
  • Global clinical research background
  • Phase Ia–III: oncology, gynecology, pulmonology
  • CRA → Clinical Scientist III → PM progression
  • Reduces complex-study execution risk
Regulatory Start-up & PM Lead
  • CTA → CRC → Regulatory Affairs Manager → PM
  • Regulatory packages + local approvals
  • Strong English-facing sponsor communication
  • Reduces startup delay and documentation loss
Project Operations & EDC Lead
  • Owns timelines and documentation quality
  • EDC deployment + clinical data cleaning
  • TMF control, monitoring coordination
  • Reduces execution drift and TMF gaps
CDM & EDC Systems Lead
  • Database structure, EDC config, validation logic
  • System requirements and IT implementation
  • Bridge between data processes and technical systems
  • Reduces data-system architecture risk
Principal Biostatistics Lead
  • M.S. Biostatistics for Clinical Trials
  • SAS, R, CDISC depth
  • Data-to-analysis continuity
  • Reduces analysis-continuity risk
Medical Writing & Scientific Documentation Lead
  • MD background: anesthesiology / intensive care
  • Bridges protocol/report development with EDC logic
  • Scientifically credible documentation
  • Reduces medically weak documentation risk
Contracts & Document Coordination Lead
  • Contract flow + document movement
  • Project administration + site coordination
  • Disciplined coordination across workflows
  • Reduces friction in document handling and timelines
Engagement Models

Engagement Models

Flexible entry points. One accountable interface.

01

Full-Service Ukraine Delivery

  • End-to-end sponsor-facing coordination for Ukraine programmes
  • One accountable interface for governance and escalation
  • Suitable when a single vendor and full control are preferred
02

Functional Service Modules

  • Targeted support: regulatory, monitoring, biometrics, writing or data management
  • Sponsor retains central control
  • Flexible scope — only the functions needed
03

Ukraine-First + EU Extension

  • Start in Ukraine, extend to EU when the protocol requires it
  • Flexible country strategy without changing governance logic
  • Partner coverage available for broader geographic reach

Illustrative First 90 Days Roadmap

STEP 1
Feasibility & Scope Alignment
STEP 2
Country / Regulatory Strategy
STEP 3
Site & Vendor Mobilisation
STEP 4
EDC / Reporting Setup
STEP 5
Launch Governance & Status Cadence
Contact

Request a Feasibility Discussion

Tell us about your programme. We will respond within one business day.

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Based in Ukraine. Serving European and international sponsors.

EESD GROUP

Ukraine-First Clinical Research Delivery Platform

Clinical Operations · Regulatory Affairs · Biometrics · Medical Writing · Digital Oversight

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