EASTERN BIOLOGIX has developed a top-tier network of medical clinics and labs throughout Romania, ensuring standardization and efficiency in executing business processes related to biospecimen collection, processing, storage, and delivery.

We have active collaborations with both the Public and Private medical sector for conducting clinical studies and sample procurement for:

• - Oncology
• - Cardiology
• - Pneumology
• - Gastroenterology
• - Dermatology
• - Internal Medicine
• - Immunology
• - Hematology

All study activities are done in compliance with National Laws and Regulations and ICH-GCP/Declaration of Helsinki.

 

Core Services:

1. Liquid Biopsy:  Prospective sample collection for Pre-Clinical Research
2. Clinical Trials: Conducting and managing of all aspects of Clinical Studies.

 

1. Liquid Biopsy

          We prospectively collect a wide variety of biological samples for Clinical Research from sites in our Network:

a) Blood

• - Whole blood
• - Plasma
• - Serum
• - Red cells
• - Buffy coat

b) Tumor and normal tissue

• - Fresh tissue
• - Snap frozen tissue
• - Tissue blocks (FFPE - Formalin-Fixed Paraffin-Embedded)
• - Tissue H&E slides

c) Other bio-fluids

• - Vaginal & Cervical Swabs
• - Nasopharyngeal Swabs
• - Synovial and cerebrospinal fluid
• - Bone marrow aspirates
• - Sputum / saliva
• - Urine
• - Others (upon request)

2. Clinical Trials        

           We can conduct and manage all aspects of Clinical Studies  according to Local and International regulations:

• - Regulatory and Access Consulting
• - Feasibility & Clinical Study Design
• - Site Selection & Clinical Study Start Up
• - Training of all involved Study Personnel
• - Patient Recruitment
• - Clinical Study Execution & Monitoring
• - Clinical Trial Supplies & Logistics
• - Clinical Data Management and Reporting

We can conduct following types of Clinical Studies:

1. Feasibility and Pilot Studies
2. Screening Studies
3. Interventional Studies
4. Observational studies:
   • Cohort studies
   • Case control studies
   • Cross sectional studies

In fulfilling our customer’s demands, our services include the following key elements:

1. Best practices in adherence to international regulations & ethical standards
2. Project life cycle management
3. Site monitoring & coordination, training of site staff, strict adherence to collection protocols
4. State of the art Laboratory: offering customized Lab processes, with the capacity of processing thousands of biological samples in pre-analytical phase.
5. Secure storage facility with continuous alarm and temperature monitoring for our biological samples:
   1. Ambient temperature (15-25C)
   2. Refrigerators (2-10C)
   3. Freezers (-20C)
   4. Ultra-freezers(-86C) with CO2 back-up system
6. Logistics Department:
   1. IATA Certified
   2. International via DHL Medical Express
   3. Local via (TNT) FedEx & via EB licensed Courier
   4. Frozen samples shipped via Dry-Ice (stable and preferred method)
   5. Ambient samples shipped with smart packaging & temperature tracking
   6. Samples can be shipped within 24 hours of collection
7. Custom build proprietary EDC system for registration and reporting of collected medical information GDPR compliant.
8. Archiving solutions of Clinical Data.
9. ISO 9001:2015 Certified