International Gynecology Case Study

Multinational Recruitment of 1,500 Women Across Three Countries

Client

A global pharmaceutical company

Study overview

A prospective international, multicenter, observational cohort study evaluating pregnancy progression and outcomes in women using different vitamin-support regimens before and during pregnancy.

The study included women aged 18–45 who were planning a pregnancy or had a confirmed pregnancy of up to 12 weeks. Treatment decisions were made by the participants and their physicians as part of routine clinical practice.

The research program was designed to collect real-world data on:

• uncomplicated full-term delivery;
• anemia during the third trimester;
• preeclampsia;
• fetal growth and birth outcomes;
• women’s well-being throughout pregnancy.

Each participant was followed for up to 18 months, with data collected during five routine clinical visits.

Project scale

• 1,500 participants
• 3 countries: Russia, Kazakhstan and Uzbekistan
• 33 cities
• 60 clinical centers
• Recruitment conducted from November 2021 to December 2023

The challenge

The Sponsor required the enrollment of 1,500 women across a large and geographically diverse network.

The project involved several operational challenges:

• Coordinating recruitment across three countries and 60 clinical centers
• Identifying eligible women during a limited period before pregnancy or within the first 12 weeks of pregnancy
• Maintaining consistent study procedures in a real-world clinical setting
• Managing recruitment in separate country waves
• Restarting enrollment in Kazakhstan after an extended interruption
• Ensuring that recruitment timelines supported the subsequent long-term follow-up of participants

SDD’s approach

Smooth Drug Development implemented a country-specific recruitment strategy supported by centralized project coordination and continuous site-performance oversight.

The operational approach included:

• Phased activation of countries and clinical centers
• Close cooperation with investigators and site teams
• Regular monitoring of recruitment performance
• Focused support for high-performing centers
• Rapid identification and resolution of operational barriers
• Structured preparation for the restart of recruitment in Kazakhstan
• Coordinated management of recruitment across Russia, Kazakhstan and Uzbekistan

This flexible model allowed recruitment activities to be adapted to the situation in each country while maintaining the overall study target.

Recruitment results

Russia

All participating Russian centers began recruitment in November 2021. Within approximately five months, the Russian sites enrolled 536 participants.

Recruitment in Russia was completed by March 2022.

Kazakhstan — initial recruitment period

One clinical center in Kazakhstan was activated in February 2022. In less than two months, this single center enrolled 46 participants.

Kazakhstan — recruitment restart

Recruitment in Kazakhstan was resumed in March 2023 and continued for eight months. During this period, the participating centers enrolled additional 468 participants.

The total enrollment in Kazakhstan reached 514 participants.

Uzbekistan

Recruitment in Uzbekistan was conducted over six months, from June to December 2023. The Uzbek sites enrolled 450 participants.

Overall outcome

The multinational recruitment target was achieved in full: 1,500 women enrolled across three countries          

Value delivered

The project demonstrated SDD’s ability to:

• Manage large-scale observational research across multiple countries
• Rapidly recruit women during early pregnancy and preconception
• Coordinate an extensive network of clinical centers
• Successfully restart recruitment following a prolonged interruption
• Adapt operational strategy to country-specific conditions
• Deliver a balanced contribution from Russia, Kazakhstan and Uzbekistan
• Achieve the full recruitment target while supporting long-term participant follow-up
• Perform full-service clinical study from concept development to CSR and study article in a peer journal.

Smooth Drug Development delivered the complete enrollment target and provided the operational flexibility required to successfully execute a complex multinational real-world study.