Publications     News     About    Contact

Solutions & Services

Therapeutic expertise

Why APICES

Submit RFI/RFP
MENU

Case study
Multinational RWE Study: Accelerating Real-World Evidence Across Europe 

A multinational pharmaceutical company launched a prospective, non-interventional study to evaluate the real-world performance of a recently commercialized analgesic treatment. The study aimed to generate early data on quality of life and safety outcomes to support commercial activities in key European markets.

The planned recruitment target was 400 patients across 10 European countries, involving approximately 40 clinical sites.

The Challenge

Executing a multinational non-interventional study required navigating a highly complex operational environment, with significant variability in regulatory requirements and site practices. Success depended on rapid site activation, consistent execution, and close collaboration with the sponsor.

Heterogeneous regulatory frameworks across 10 European countries

Tight timelines to support commercial and market access strategies 

Identification of eligible patient populations across diverse healthcare systems 

Need for strong investigator networks and local country expertise 

The APICES Approach

APICES implemented a pan-European, integrated execution model, designed to maximize speed, quality, and operational efficiency.

Key elements of the approach included:

  • Development of a country-prioritized regulatory and start-up strategy, based on approval timelines, recruitment potential, and strategic importance
  • Centralization of monitoring activities at APICES headquarters to ensure consistency, quality control, and cost efficiency
  • Rapid mobilization of key opinion leader networks across participating countries to support site engagement and recruitment
  • Close operational integration with the sponsor to identify and activate eligible patient populations

This structured yet flexible model allowed APICES to manage complexity while maintaining tight control over timelines and performance. The study was successfully delivered within the required timelines, generating high-value real-world evidence.

Recruitment objectives achieved on time across all participating countries
High-quality RWE data supporting safety and quality-of-life analyses
Multiple scientific and commercial outputs, including publications, congress presentations, and marketing materials
Public sponsor recognition of APICES’ operational excellence and partnership approach

This case study highlights APICES’ ability to execute large-scale, multinational RWE programs aligned with both scientific and commercial objectives.