Clinical trials services
PHARMBIOTEST is a Ukrainian contract research organization (CRO) providing a broad range of clinical research services for pharmaceutical, generic drug and healthcare companies. PHARMBIOTEST offers comprehensive clinical trial services on Phase 1–4 clinical trials with emphasis on pharmacokinetic, bioavailability and bioequivalence studies. Our policy in quality management is founded on the established precepts of Good Clinical (GCP) and Good Laboratory Practices (GLP), which are embedded in all spheres of our activity, processes and procedures.
List of provided services:
- Investigator's Brochure
- Information for patients
- Informed Consent Form
- Standard Operating Procedures (SOPs)
All documents meet the requirements of ICH GCP standards, standards submitted to FDA, EMEA, regulatory requirements.
Clinical site selection
Due to good cooperation with medical centers, we can quickly select the most suitable clinical sites for your trial. We always act in the interests of our clients; therefore, developing the budget of your research, we will contact all the bases suitable for you and choose the best one, with an acceptable price for you and at the same time guaranteed high quality of research.
Our team take over logistics related to delivery of the necessary components to the clinical site.
We offer next services:
- Transportation and storage of all medicinal products and materials
- Compliance with the temperature regime of storage and transportation
- Delivery of biological samples to bioanalytical laboratory
Clinical Site Monitoring
PHARMBIOTEST provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits.
Clinical Site Monitoring Services include:
- Site identification
- Preparation of study documents
- Regulatory document collection
- Site protocol training
- Adverse Event and Serious Adverse Event training
- Monitoring Report and letter to the Investigator after each visit
- Site management and correspondence
- Recruitment strategy
- Monitor and/or audit sites for compliance with the clinical protocol and GCP Regulations
- Site initiation
- Interim site monitoring
- Device accountability oversight
- Combined interim and close-out visit
- Site closure
- Assists with the maintenance of clinical study files.
PHARMBIOTEST provides statistical support of clinical trials (pharmacokinetic studies and bioequivalence studies, dose-proportionality, efficacy, tolerability, safety, etc.):
- sample size calculation (number of subjects required for the study)
- development of randomization scheme
- development of statistical plans
- statistical analysis of the clinical part of the study
- preparation of reporting documents for statistical data processing
- Final Report writting
- other services of statistical data processing in accordance with customer wishes.
All processes are conducted in accordance with international standards, state regulatory requirements and standard operating procedures.
Please contact our team at email@example.com to discuss your specific needs and application.