Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Amy Scalise, Associate Director, Decentralized Clinical Trial Management
What do you do at ProPharma? How does your role support our higher purpose of improving the health and safety of patients?
As the Associate Director, DCT Management I am responsible for ensuring that clinical research studies are conducted in compliance with SOPs, principles of GCP, and applicable federal, state, and local regulations, with the ultimate goal of improving the health and safety of patients. By overseeing the operational management of project team staff for DCT, I help ensure that research is conducted ethically, safely, and with high-quality standards. This includes reviewing deliverables, developing best practice guidelines, and conducting team performance appraisals, contributing to the efficient and effective execution of clinical trials.
My role also involves collaborating with internal and external stakeholders, including clients and business development teams, to identify new opportunities and ensure that studies are conducted with the highest level of quality and integrity. Ultimately, my efforts contribute to advancing the development of new drugs and therapies, improving patient outcomes, and enhancing the overall quality of healthcare.
What is your number one goal / focus right now?
Currently, my number one goal and focus is to ensure the successful execution of assigned DCT clinical research studies. This involves several key tasks, including:
- Overseeing the hiring and project team allocation process to ensure the right people are in place to deliver successful outcomes.
- Coordinating with clients to understand their needs and expectations and ensure their goals are aligned with project objectives.
- Ensuring compliance with regulations and guidelines to maintain ethical standards and protect patient safety.
- Developing and implementing best practices for efficient and high-quality project execution, which includes identifying and addressing potential issues before they become problems.
- Prioritizing the support and development of relationships with clients and team members to facilitate successful project delivery, which includes ensuring clear communication, managing expectations, and fostering a collaborative work environment.
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
One of the biggest challenges facing the life science industry today is the increasing complexity of clinical trials. As clinical research becomes more complex and costly, sponsors and researchers are faced with several challenges, including patient recruitment and retention, data management and analysis, regulatory compliance, and cost containment.
To address these challenges, the industry can adopt several strategies, including embracing DCT options for sites and patients. Working closely with sites, patients, communities and a trusted DCT provider to develop solutions can help improve patient recruitment and retention, as well as foster greater trust between patients and researchers. Often, the goal is to reduce site burden and partner with the site as an extension of services all while not cutting sites out of the picture entirely.
By addressing challenges, developing a robust suite of options, and adopting innovative approaches to clinical research, the industry can continue to advance the development of new therapies while addressing patient outcomes.
What is a current trend you’re seeing in the industry and how does it impact our clients and patients?
The life science industry is currently experiencing a trend towards increased adoption of telemedicine and virtual care, accelerated by the COVID-19 pandemic. Telemedicine involves the use of digital technologies, such as video conferencing and remote monitoring, to provide medical care and services remotely. This trend has significant implications for both clients and patients, specifically in DCT.
By leveraging decentralized clinical trial options, researchers can conduct studies that are more patient-centric and inclusive, leading to improved patient outcomes. The use of decentralized trial strategies offers many potential benefits, such as increased patient participation, improved patient convenience, enhanced data quality, and reduced costs. Additionally, decentralized clinical trials can help address historical barriers to participation in clinical trials, such as patient recruitment and retention, diversity, site burden and travel costs.
As DCT continues to evolve and gain acceptance, it has the potential to revolutionize the way clinical trials are conducted. This can make them more efficient, effective, making them more efficient, effective, and accessible to a broader range of patients. The adoption of telemedicine, virtual care, and DCT options has the potential to improve patient outcomes while addressing long standing challenges in the industry.
What value does a client gain by working with ProPharma’s Decentralized Clinical Trial experts?
Collaborating with ProPharma’s DCT experts can provide numerous benefits for clients in the life science industry. DCT is an innovative clinical research approach that uses digital tools and platforms to conduct trials remotely, outside of traditional clinical settings.
By leveraging the expertise of DCT professionals, clients can expect faster study start-up times through virtual recruitment and screening methods. DCT experts can also help design studies that promote increased patient engagement and retention, utilizing digital tools like mobile apps and wearables. Additionally, they can implement data capture systems that improve the quality of data, leading to more robust study results.
By conducting trials remotely, DCT experts can help clients reduce site-related costs while maintaining study flexibility and compliance with the latest regulations and guidelines. Overall, working with DCT experts offers clients an opportunity to conduct clinical trials more efficiently, cost-effectively, and with greater confidence in the quality of data.
