Integrated services that can be combined or used independently — and expanded as your programme grows.
From first-in-human studies to post-marketing surveillance, we run Phase I–IV trials end to end: feasibility, site selection and start-up, monitoring, data management and close-out. Our teams combine deep local regulatory knowledge across Eastern Europe, the EAEU and Central Asia with international-standard processes, giving sponsors predictable timelines, inspection-ready documentation and a single accountable partner across every country in the study.
We support pre-market and post-market clinical investigations of medical devices, including first-in-human, pivotal and post-market clinical follow-up studies. We align study design, ethics and competent-authority submissions and site training with ISO 14155 and applicable regional requirements, and we manage device accountability, adverse-event reporting and investigator support from the first site visit to the final report.
Clear, scientifically rigorous documents shorten approval timelines. Our medical writers prepare protocols, investigator brochures, informed consent forms, clinical study reports and regulatory submission documents in line with ICH guidance, along with plain-language patient materials. Every document is reviewed for consistency with the protocol, the statistical analysis plan and the underlying data.
Patient safety is non-negotiable. We provide adverse-event collection and case processing, serious-adverse-event and SUSAR reporting to regulators and ethics committees, aggregate safety reports, signal detection and safety-database management. Our pharmacovigilance specialists work directly with clinical operations so that safety information reaches the right people within the required timelines.
Good statistics begin at the design stage. Our biostatisticians support sample-size calculation, randomisation, statistical analysis plans, interim analyses and data-monitoring committee reporting, followed by validated tables, listings and figures. Programming follows CDISC standards so datasets are ready for regulatory submission and for pooling across studies.
Our eTMF gives sponsors and sites a single, always-current view of study documentation. Structured around the industry-standard TMF reference model, it provides real-time completeness tracking, quality-control workflows, role-based access and a full audit trail, so your trial master file is inspection-ready on any day of the study, not just at close-out.
We design, build and host electronic data capture systems tailored to each protocol. Services include eCRF design, edit checks, query management, integration of laboratory and patient-reported data, and database lock. Controls for audit trails, electronic signatures and personal-data protection are built in, supporting both data quality and GDPR obligations.
Our clinical operations teams turn protocols into well-run studies. Dedicated project managers and clinical research associates handle feasibility, site activation, on-site and remote monitoring, risk-based quality management, vendor oversight and investigational product logistics, with transparent reporting so you always know where enrolment, quality and budget stand.
Regulatory complexity is where many multi-country studies lose time. We prepare and submit clinical trial applications, manage ethics committee approvals, coordinate import and export of investigational products, and advise on national and EAEU pathways. As we introduce our services to the US market, we also help sponsors coordinate regional strategy with their US regulatory partners.
Tell us about your programme and we will respond with a tailored proposal.