Clinical Trial Start-Up in Eastern Europe: A Sponsor Checklist

A well-prepared start-up avoids most of the delays sponsors meet in multi-country studies. Use this checklist to organise the work before the first submission.

Before you approach countries

Protocol synopsis, target population, inclusion and exclusion criteria and key endpoints.
Investigational product type, supply route and comparator or standard-of-care assumptions.
Target countries, planned number of sites and expected start-up and enrolment timeline.
Budget principles, insurance approach and the services you want to outsource.

Feasibility and site selection

Confirm that investigators see enough eligible patients and that competing studies will not exhaust the same pool.
Check site equipment, laboratory arrangements, staffing and previous experience with the study phase.
Record realistic enrolment assumptions per site rather than regional averages.

Regulatory and ethics package

Identify the submission route for each country: EU Clinical Trials Regulation through CTIS in Latvia, Lithuania and Poland, and national procedures in non-EU countries.
Plan translations of subject-facing documents and any national forms early.
Prepare responses to authority and ethics questions in parallel with site work.

Contracts, budgets and site activation

Start site agreements and budgets as soon as sites are selected, because negotiation is a frequent cause of delay.
Align insurance documents, investigator documents and training records.
Agree the investigational product import, labelling and storage plan before activation.

Questions to ask a CRO

Which of the countries and services do you handle with your own staff?
How do you track submissions, queries and site activation, and how often will we receive status reports?
Who is our single point of contact, and how are issues escalated?

Discuss your study

Share your protocol synopsis and target countries, and we will respond with a feasibility view.

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