Clinical trials

Briefly about Dila experience in clinical trials for the last 5 years:

• Central lab services in more than 130 trials;
• 45 000 Requisitions registered and reports released
• More than 400 000 laboratory tests for clinical trials;
• More than 400 investigator sites have been supported.

Management of studies is divided onto main areas:

• Project management and site support team;
• Data management;
• Logistics services;
• Laboratory testing;

All activities in these areas are regulated by company’s Quality Management System based on ISO 9001, ISO 15189 standards, GCP and GCLP recommendations.

Project management includes:

• Effective implementation of protocol requirements, trainings of involved personnel;
• Preparation of laboratory manuals for investigators, Requisition Forms and shipping instructions;
• Training of investigators upon Client’s request
• Design and manufacturing of protocol-specific and visit-specific lab kits, their shipment to the sites, resupply services;

• Proactive collaboration with investigators, teaching of the details of sample collection, storage, shipping and analytes’ stability, assistance in results interpretation

Laboratory services:

State of the art equipment by the world’s leading manufacturers (Siemens, Abbott, Bio-Rad, BioMerieux) and dedicated qualified team enables to deliver reliable results in the following fields:

• Cytology / Hematology / Urinalysis
• Routine chemistry
• Immunology
• Serology
• Coagulation
• Microbiology
• PCR / Molecular biology

Data management:

• Preparation of study-specific predefined database meeting protocol requirements;
• Results verification and authorization prior to reporting;
• Data clarification;
• Electronic data transfer in export data files that can be formatted according to specifications and software formats required;

Logistics services enable to guarantee fast turnaround time and appropriate temperature regimen during transportation:

• Nationwide network of outsourced (international courier companies) and back-up staff couriers for samples’ pick-up and shipment;
• About 10 000 shipments annually from all the regions of Ukraine;
• Shipments of AMBIENT, REFRIGERATED and FROZEN samples from the regions of Ukraine within 18 – 24 hours which ensures minimal risk for analytes’ stability and fast result turnaround time;

• Contingency options to ensure safe delivery and prevent sample loss
• Delivery of samples on weekends and holidays

Why Dila?

• The most experienced laboratory in Ukraine accredited according to international standards
• High capacity for a big number of specimens
• State of the art equipment and dedicated team
• Fast result turnaround time;
• Acceleration and high efficiency of patient recruitment;
• Flexibility in meeting Sponsor’s requirements
• Cost effectiveness;
• Complete site support;
• Guarantee of the accuracy, completeness, timeliness of all the reported data
• Archiving of all study related documentation

A notarized version in English of the accreditation certificate in accordance with the requirements of DSTU EN ISO 15189:2015 (EN ISO 15189:2015, IDT) can be downloaded here.