Seguridad del paciente en ensayos clínicos

Patient safety in clinical trials: A focus on pharmacovigilance and post-approval in Latin America

by Fortrea

Managing pharmacovigilance (PV) and post-approval operations is complex in today's globally diverse and evolving regulatory environment. Through a few case studies at a client symposium in São Paulo, Brazil, the Fortrea global safety team recently shared how they are continually optimizing their services to help promote product safety, quality and regulatory compliance for drug development sponsors working in Latin America (LATAM). This article shares the highlights through three case studies.

Case Study 1: Globalizing medical information with a LATAM base

A global client with large portfolio across CNS diseases, cardiovascular diseases and oncology needed support for Medical Information Call Center (MICC) services. This involved 17 countries and 10 languages with up to 180,000 queries per year, which included 10,000 queries in Latin America.

Fortrea started by consolidating disparate vendors and more than 20 databases to create a single global database. The team then launched a three-pronged strategy to unite work instructions into one global document as well as centralize all IT services.

A local hub model was based in Brazil where dual language speakers (Portuguese and Spanish) could cover multiple countries and support US and EU time zones. Along with central governance and uniform global processes, the team successfully supported multiple audits and inspections.

Case Study 2: Implementing a new management model with multi-lingual capabilities

A global specialty company with more than 100 products across the U.S., EU, LATAM and APAC was facing a critical finding from a Health Authority inspection. Issues at the local affiliates included unlogged requests, staff unaware of the available tools and services, insufficient staffing and multiple affiliates managing different tracking systems with overlapping processes.

Recognizing that the model could be more efficient, Fortrea worked collaboratively with the client to divide the affiliates into two groups. One group handed the live calls for high-volume countries while the second group functioned as the support for low-volume countries. Redundant staff were identified, and resources were reassigned to cost-effective locations.

Fortrea also implemented a centralized governance structure along with standardized global procedures augmented by local work instructions and unified training. Global tracking and reporting for metrics were also put in place to track the results of this successful collaboration.

Case Study 3: Analyzing the results of a pilot study for AI intake and translation

As part of ongoing process improvement, the Fortrea team explored how its manual process for translation requests could leverage artificial intelligence (AI) platforms to increase the efficiency of the translation process and use proprietary automation to reduce the risk of human error in manual processes.

In a pilot study, they observed a 40-50% increase in efficiency across all LATAM languages with a field level accuracy of 75% in Spanish and 80% in Portuguese for AI-generated translations. The team also developed a dashboard for inventory monitoring and case assignment to monitor events of special interest and track the team's overall translation accuracy.

At Fortrea, we’re honored to support more than 150 long-standing clients around the world as we implement more cost-effective and quality-focused process improvements that address their unique needs. Learn more about our end-to-end Patient Safety & Pharmacovigilance services.