Clinical trials
Clinical trials contribute to developing innovative medicines
by providing evidence for the safety and efficacy of the drugs.
Aston Health’s team helps organizations to conduct
clinical trials in various fields of medicine. We seek to bridge together the
developers and manufacturers of pharmaceuticals and the CROs in Russia and CIS
countries.
The practical aspects of our assistance include:
- Development of research documentation. The documents
are developed in close collaboration with medical experts and in compliance with
global standards and the local legislation.
- Selecting centers to conduct clinical trials. This
includes developing technical requirements and training related to SOP and GCP
issues.
- Project management. Ensuring compliance with project timeline,
budget and performance quality standards.
- Monitoring compliance with clinical trial regulations
(ICH GCP) and the Russian legislation. Handling protection of patients' rights,
trial safety oversight and quality assurance.
- Logistics support. Our proprietary Quinta Lab system
facilitates rapid and accurate subject randomization. It also allows for easy
drug inventory management to support clinical trial needs.
- Data processing. Quinta Clinical is a proprietary
solution for online management of clinical trials that allows 24/7 access to
clinical trial data.
- Biostatistics. Our experts are involved at every stage
from development of SAPs based on protocol to delivery of final statistical report.
Clinical patient registries
Epidemiological studies
Laboratory diagnosis
Registration of drugs and medical devices