Can the CRO include international sites?
Yes — Biostat® has the experience and infrastructure to manage multinational clinical studies, including selecting and coordinating international sites.
We work with CRO partners, clinical centres and medical institutions in the EU and beyond.
Biostat® acts as a single point of contact, ensuring coordinated communication, unified operations and full visibility for the sponsor.
How it works in practice
For international studies, we:
• select sites in EU and non-EU countries,
• manage local regulatory and ethical submissions,
• coordinate translations of all documentation,
• negotiate contracts with sites and vendors,
• standardise operational plans, budgets and schedules across countries,
• oversee monitoring and data quality via unified systems (eCRF, CTMS, eTMF),
• provide centralised reporting.
This approach gives sponsors transparency, cost control and simplified communication.
Why choose Biostat® for international studies?
International studies require coordination across different legal, cultural and operational environments.
Biostat® ensures consistency in methodology and quality across all participating countries.
With experience in Germany, Czechia, Norway, Italy, the Baltic States and more, we can adapt to local realities while maintaining a unified global strategy.
Working with Biostat®, you gain:
• a realistic and resource-based study plan,
• a risk-aware and buffer-based timeline,
• access to a verified international site network,
• IT tools for continuous project tracking,
• a dedicated Project Manager overseeing the entire workflow.
How to start working with us?
Simply send a short description of your project — objectives, scope and planned locations.
Within 1–2 business days, we will propose an online meeting to present the action plan, potential countries and a preliminary timeline framework.
With Biostat®, you can execute your study internationally — from a single management point, fully compliant with GCP and MDR, and tailored to regulatory expectations.
