BIOCARD

SPRI Ukraine, LLC is a regional full-service contract research organization (CRO), experienced in performing clinical trials in Ukraine. We provide a wide range of research services for pharmaceutical and biotech companies, interested in conducting clinical trials in Ukraine, Russia, and countries of Eastern Europe. We are the integrated team of high professionals with expertise in managing and execution of clinical trials, offering cost-effective and time-sensitive solutions for conducting clinical studies.

SPRI Ukraine offers the high quality services to speed up the clinical development process for your product. Our aim is to satisfy our clients requirements and needs in a timely and cost-effective manner by providing your projects with all the expert support with the emphasis on a priority of patient health status. Below is a list of the services we offer.

-Project Management and Clinical Trial Monitoring
-Regulatory Support/Regulatory Submission
-Legal Assistance
-Logistical Support
-Market Authorization Support
-Finance Management
-IMP and CTM Import, Storage and Distribution
-Investigators Metting Organization
-Feasibility Activities and Site Selection
-Customs Clearance
-Translation Services

(In Ukraine, Clinical Trials Regulations are harmonized with respect to current European Directives and ICH GCP.)

Smooth Drug Development offers a full range of clinical trial, drug registration and post-marketing services, including consulting, development of registration strategy, conduct of clinical studies and pharmacovigilance. We cover wide geography:
-Russia
-Ukraine
-Belarus
-Kazakhstan
-Latvia
-Lithuania
-Estonia
-Serbia
-Slovakia
-Hungary
-Germany
-Spain

Our company implemented the principle of "one stop service" when all activities from planning to product registration are performed consistently under the control of a team of professionals. According to the requirements of ISO 9001:2015, in case of outsourcing of vendors we manage their activities as our ones and are fully responsible for the results.

Our Clients are leading pharmaceutical, biotech and R&D companies located in Europe, US, CIS and Asia-Pacific region.

We offer drug development services:
-Consulting center
-Pre-clinical research
-Clinical trials
-ePRO
-eTMF/eISF
-Drug registration
-Post-marketing surveillance
-Pharmacovigilance
-Training center

We are experts in clinical services:
-Project management
-Medical writing
-Feasibility and site selection
-Regulatory support
-Data management
-Logistics and storage
-Clinical monitoring
-Medical monitoring
-Pharmacovigilance
-Bioanalytical and central laboratories
-Biomedical statistics
-Clinical study report
-GCP audit

Smooth Drug Development has unique IT solutions for clinical trials which help to speed up clinical trials processes and daily activities. Smooth CTMS includes the following modules:
-EDC/eSource/IWRS
-eTMF/eISF
-ePRO
-Learning / QMS
-Personal Folder
-Clinical Monitoring

Smooth Drug Development has been ISO certified:
-ISO 9001:2015 Quality Management Systems
-ISO 27001:2013 Information Security Management Systems
-ISO 22301:2019 Business Continuity Management Systems

Smooth Drug Development works with Life Science Marketplace. Find us there.

Please contact us at bd@smoothdd.com to learn more about Smooth Drug Development capabilities.

SynCon International is a clinical research consultancy, specialised in the emerging regions.

SynCon International offers clinical research services, as well advice and expert support in the areas presented below:

- Clinical trials services in the emerging markets of CEE, Russia, Byelorussia, Kazahstan and Latin America

• Feasibility analysis
• Site identification
• Identification of investigators
• Investigator Contracts
• Regulatory Authority Submission
• Logistics (translation, meeting organization, etc.)
• Patient recruitment and retention strategies
• Monitoring
• Stats and Data Management
• Clinical Trial Compliance Management

- Recruitment and outsourcing of clinical trial personnel CEE, Russia, Byelorussia, Kazakhstan and Latin
America

- Strategic business development consultancy

Accell Clinical Research is an international full-service Contract Research Organization (CRO) managing Phase I-III clinical trials for 10+ years across Eastern Europe. With local presence, including highly qualified medical staff and legal entities in the region, we successfully recruit patients both in EU and outside EU in post-Soviet countries (CIS). All together we provide guaranteed fast patient recruitment in 20+ countries across the region.

⬇︎ ACCELL'S SERVICES for Phase I-III clinical trials:

• Strategic guidance and trial set-up:
• Feasibility research and site selection
• Study documentation development
• Regulatory support
• Clinical supply import and management
• Selection and management of clinical study vendors
• Project management
• Clinical & medical monitoring
• Data management and biostatistics
• Quality assurance
• Safety management
• TMF/eTMF services
• Functional outsourcing of a clinical team

⬇︎ THERAPEUTIC AREAS
• Oncology
• Cardiovascular
• Immunology
• Gastroenterology
• Neurology
• Endocrinology

ANTAEA Group of Companies is one of the largest Regional Clinical Research Organizations (CROs), providing high quality support in Southeast Europe, North Africa, Middle East and the Gulf Area.

The Group provides professional, yet flexible solutions, supporting our Clients to maximize their Research resources, in a cost effective manner. ANTAEA is dedicated to Services of scientific quality, management expertise, precision and reliable technology.

The Group includes integrated, marketing consultation services in our portfolio, based on Market Research, which cover products throughout their life cycle.

Specialities: Feasibility Projects, Initial Submissions, Amendments and Notifications to ECs (local and central) and Regulatory Authorities, Clinical Trials Monitoring in several different phases, Contracts for Clinical Trials Management, Contracts for Clinical Trial Rescue Projects, Design and Development of Clinical Trials Projects, Investigator Initiated Projects, Regulatory & Registration Projects (National, MRP, Variations etc.), Statistical Projects, Contracts for Investigator Training, Contract for Regulatory Services Training, Contract for Site Audit

ANTAEA also provides experienced CRAs to the Pharmaceutical and Biotechnology Industries and to CROs, in all the countries where ANTAEA is operating. ANTAEA training on procedures and setting standards and our technical support, guarantee uniformity in quality and timely delivery of projects.