Expert Interviews
Interview with Paola Engelmann Arantes: Key Insights on Site Management, Patient Retention, and the Future of Clinical Research in LATAM
As part of our interview series spotlighting professionals advancing clinical research across the world, we are pleased to introduce Paola Engelmann Arantes, a Biomedical Scientist with deep expertise in Toxicology, Oncology, and Cardiovascular Therapies. As a CRA, Paola plays a vital role in managing sites in multicenter studies, ensuring regulatory compliance, promoting patient retention, and enhancing site training across Brazil, the United States, Canada, Argentina, Colombia, and Mexico.
Joining us today is Merter Ortac, a seasoned expert in Medical Devices, Oncology, Hematology, Clinical Monitoring, and Good Clinical Practice (GCP). With a robust background in business development and a Master’s degree in Japanese Language and Literature from Ankara Üniversitesi, Merter brings a unique and insightful perspective to the discussion on clinical research in Turkey.
ABRS: Can you walk us through your process for managing routine site activities to ensure compliance with study protocols and regulatory guidelines?
Paola Engelmann: I currently oversee approximately 30 sites, and I use a daily prioritization system to ensure compliance with protocols and regulations. Each morning, I assess tasks based on urgency, using a structured time allocation approach. I begin with critical issues and then address routine tasks such as data review and site communication.
Flexibility is essential in monitoring, as it allows me to respond to urgent matters promptly without compromising regulatory compliance.
ABRS: What strategies do you use to support patient recruitment and retention? Have you faced challenges in this area, and how did you address them?
Paola Engelmann: For recruitment, I maintain close communication with sites, send weekly reminders, and create WhatsApp groups to encourage collaboration. I also acknowledge and congratulate sites on each new randomization, which helps sustain motivation—even in studies with strict inclusion/exclusion criteria.
Retention is more challenging, as it heavily depends on the site. When possible, we provide financial support for transportation, meals, or other patient-related costs. If that’s not feasible, we implement alternatives such as remote or phone visits to make participation more convenient.
ABRS: How do you handle situations where a site has questions or concerns about the study protocol or sponsor requirements? Can you give an example of how you’ve resolved a complex issue?
Paola Engelmann: I maintain open communication with the sites. I often receive calls or messages from investigators or coordinators, and I aim to address concerns promptly. When a quick resolution isn’t possible, I schedule online meetings for a more in-depth discussion.
In one study with a complex protocol and CRF, several sites struggled with the procedures. I organized multiple retraining sessions covering both the protocol and CRF. Even after training, some sites needed extra help, and I made sure to be available every step of the way.
ABRS: What key recommendations would you give to someone new to the role of a CRA, particularly in managing site activities and ensuring protocol adherence?
Paola Engelmann:
Stay flexible but structured: Unexpected issues will happen. A risk-based approach that prioritizes tasks by urgency and impact is essential, but flexibility is also key.
Be highly organized: With multiple studies and sites, organization is critical. Use tools and strategies to track site progress, ensure compliance, and maintain protocol adherence.
ABRS: How do you see the current state of clinical research in Brazil, and what opportunities or challenges do you foresee for the future in this region?
Paola Engelmann: Clinical research is expanding significantly in Brazil, with growing interest from sponsors and organizations. This growth presents valuable opportunities for advancing healthcare.
However, one of the main challenges is the lack of research training in many hospitals and clinics. While this is a barrier, it also represents an opportunity to strengthen infrastructure and build a well-trained research workforce.
Thank you, Paola, for sharing your experience and insights on the evolving landscape of clinical research in LATAM.