Shauna Cusack, host of Clinic on Cue, explores the complex field of clinical research with Aoife Lonergan, Senior Project Manager of Atlantia Clinical Trials, in this episode. Join us as we explore the fundamental procedures, difficulties, and developments in the subject, using Aoife's wealth of knowledge and perspectives.
Table of Contents
- Understanding the Role of a Senior Project Manager
- Key Processes in Clinical Trials
- Communication with Sponsors
- The Importance of Communication in Clinical Trials
- Challenges in Conducting Clinical Trials
- Recruitment Strategies and Data Quality
- Technological Advancements in Clinical Trials
- Conclusion
- Key Takeaways
- FAQ
Understanding the Role of a Senior Project Manager:
Aoife Lonergan, Senior Project Manager at Atlantia Clinical Trials, provides a comprehensive overview of her role and daily responsibilities. Her position involves managing a team of project managers who are tasked with delivering high-quality studies on time and within budget, all while adhering to ICH GCP principles.
What does a typical day look like for a Senior Project Manager?
"My days are busy and varied, which keeps my work interesting. I oversee different aspects of clinical studies, from setup through to conduct and close-out, while also managing a team of project managers. In addition to leading my team, I’m hands-on with the studies myself and involved in efficiency projects and continuous improvements at Atlantia. One of the key parts of my role is working within Atlantia's multidisciplinary approach. Since we offer an end-to-end service, I get to work closely with various teams throughout all phases of a study, making my role dynamic and collaborative."
How does the project management team collaborate with other departments?
"I’ve seen firsthand how crucial cross-departmental collaboration is for delivering top-notch clinical studies. In our project management team, we don’t just work in isolation; we actively team up with folks from data management, recruitment, and science departments. By closely coordinating with these teams, we make sure every piece of the study fits together smoothly. This way, everyone’s efforts are aligned towards the same goal: producing a high-quality clinical study. It’s this teamwork that truly makes a difference in the outcome".
Key Processes in Clinical Trials:
Aoife walks us through the key processes and workflows that the operations team manages throughout the different phases of a clinical trial.
What happens during the setup phase of a clinical trial?
"During the setup phase, my role in the project management team involves a variety of crucial tasks. I collaborate with the science team to develop the study protocol, ensuring it's both thorough and practical. Before we submit any applications to the ethics committees, I review them from an operational perspective to catch any potential issues. I also work closely with the data team to establish the data collection tools we’ll need. Training the study team on visit procedures and assessments is another key part of my job, making sure everyone is well-prepared. Additionally, I partner with the quality department to develop work instructions and SOPs, so that all processes are clear and standardized."
How does the team manage the conduct phase of a trial?
"In the conduct phase, my focus shifts to several important areas. I work closely with participants, making sure they’re comfortable and informed throughout the study. Keeping them engaged is crucial, so I put a lot of effort into maintaining their interest and commitment. I also collaborate with clinical trial assistants to ensure everything runs smoothly and that we’re addressing any issues that arise promptly."
What are the key activities during the close-out phase?
"As the study nears completion, my role with the project management team involves several key responsibilities. I work closely with the data management team and statisticians to ensure that the data we’ve gathered is of the highest quality for analysis. I also facilitate the handover to the science team, who will use the data to compile the clinical study report. This final step is crucial for summarizing our findings and making sure everything is in order."
Throughout all these phases, Aoife highlights the importance of maintaining regular contact with the study sponsor to keep them updated on all ongoing activities.
Communication with Sponsors:
How often do you communicate with sponsors during a typical study?
"I’ve found that the frequency of communication with sponsors can vary based on their preferences. However, I usually follow a typical schedule, which includes weekly check-ins through calls or update emails. I make sure to provide regular updates on the activities that have happened during the week. Sponsors really value this consistent communication because it keeps them personally connected to our team and informed about the study’s progress."
What are the benefits of maintaining regular communication with sponsors?
"Regular communication with sponsors offers several benefits that I’ve noticed in my experience. It helps keep everyone on the same page, which is crucial for smooth operations. When issues come up, being in regular contact allows us to resolve them quickly. It also helps build a strong relationship between our project team and the sponsor. This close connection facilitates our efforts to work towards the shared goal of producing a high-quality study."
Aoife has pointed out that having a consistent point of contact throughout all phases of the study is particularly beneficial for both the sponsor and for the team.
The Importance of Communication in Clinical Trials:
What do you consider the most crucial aspect of conducting a successful clinical trial?
"I believe that communication is the cornerstone of a successful clinical trial. From my perspective, this means that effective communication is crucial not only within our team at Atlantia but also in our interactions with sponsors. It’s the key to ensuring everything runs smoothly and that everyone is aligned throughout the trial."
How does Atlantia facilitate effective internal communication?
"At Atlantia, our approach to internal communication includes having all teams in-house, either in the Cork or Chicago office. This setup allows for face-to-face interactions, which are great for quick problem-solving. We also foster an environment where team members feel comfortable approaching each other with questions or concerns, making communication easy and efficient."
What is the importance of transparent communication with sponsors?
"I’ve found that open and honest communication with sponsors is incredibly valuable. This means promptly informing them of any issues that arise, sharing positive news and milestones, and keeping them updated on creative solutions to challenges, like recruitment strategies. I also involve the wider team in sponsor communications to bring in diverse perspectives and experiences. This approach helps build trust and ensures that everyone is aligned with the goals for the study."
Challenges in Conducting Clinical Trials:
What are some of the biggest challenges you face when conducting a clinical trial?
"Despite our careful planning, I acknowledge that unforeseen issues can still come up during clinical trials. Some of the main challenges I encounter include recruitment difficulties and maintaining high data quality standards. These issues can test our strategies and require us to adapt quickly to keep the study on track."
How does Atlantia address recruitment challenges?
"To tackle recruitment challenges, I rely on our skilled recruitment team, which is adept at developing creative strategies to attract participants. We actively engage with participants to encourage their repeat participation in studies, which helps build a solid base of reliable volunteers. Additionally, we maintain a database of participants who have been involved in multiple studies, making it easier to recruit experienced individuals for new trials."
What steps are taken to ensure data quality in clinical trials?
"Maintaining high data quality is a top priority for me at Atlantia. My approach includes conducting regular quality checks to ensure the data is complete and consistent. I also keep an eye on data through continuous monitoring by the team throughout the study. Although this process can be labor-intensive, I’ve found that it saves time in the long run, especially during the close-out phase of a study."
How does early involvement in protocol development help address potential challenges?
"Being involved in protocol development from an early stage offers several benefits. It allows me, as a project manager, to provide input on inclusion and exclusion criteria based on real-world experience. This involvement helps identify potential issues before the protocol even reaches the ethical committee. It also enables us to suggest realistic criteria that align with actual patient populations. With Atlantia’s project managers having extensive experience across various studies and health areas, this process proves invaluable. We draw from past experiences to make informed recommendations and anticipate potential challenges effectively."
Recruitment Strategies and Data Quality:
How does Atlantia address recruitment challenges in clinical trials?
"Recruitment challenges can sometimes arise unexpectedly in clinical trials. To tackle these hurdles, Atlantia has developed effective strategies that I find quite successful. We have a dedicated recruitment team that comes up with creative ideas to attract participants. I also focus on engaging with participants to encourage their repeat participation in studies. Additionally, we maintain a database of participants who have been involved in multiple studies. This approach has allowed us to build a reliable pool of participants, which helps us effectively address and mitigate recruitment challenges."
What steps does Atlantia take to ensure data quality in clinical trials?
"Maintaining high data quality is a top priority for me at Atlantia. My approach involves conducting regular quality checks to ensure that the data is both complete and consistent. I also oversee continuous monitoring by the team throughout the study. While this process can be labor-intensive, I’ve found that it saves time in the long run, especially during the close-out phase of a study."
How does early involvement in protocol development help address potential challenges?
"Being involved in protocol development from an early stage has several benefits. I can provide input on inclusion and exclusion criteria based on my real-world experience. This early involvement helps us identify potential issues before the protocol even reaches the ethical committee. It also allows us to suggest realistic criteria that align with actual patient populations. With Atlantia's project managers having extensive experience across various studies and health areas, this process proves invaluable. We draw from our past experiences to make informed recommendations and anticipate potential challenges effectively."
Technological Advancements in Clinical Trials:
What are the most significant technological changes you've observed in clinical trials?
"The shift from paper-based data collection to digital methods has been the most significant change I’ve seen in recent years. This transition has brought several benefits. It has made data collection and management much more efficient and reduced the time we spend on manual checks. I’ve also noticed improvements in data quality and integrity, along with an enhanced participant experience. Atlantia has fully embraced this digital transformation across all aspects of our studies, from recruitment to on-site data collection, and it has made a noticeable difference in how we conduct our trials."
Can you tell us about Atlantia's new recruitment platform?
"We’ve developed a new recruitment platform in-house at Atlantia, working closely with an app provider to build it from scratch. This platform streamlines the process of booking participants for visits and facilitates both pre-screening and on-site management. It also helps manage participants throughout the conduct phase of the study. I see this platform as a significant advancement in our recruitment capabilities. We’re also planning further development to eventually include access for both participants and sponsors, which will enhance its functionality even more."
How have you seen technology integration evolve in clinical trials?
"I’ve noticed a significant increase in the use of specialized technologies in clinical trials. We’re integrating advanced equipment and software tailored for specific study types, such as skin studies or stress studies. These technologies provide more objective data, which complements the subjective assessments we collect. The combination of objective and subjective data significantly enhances the overall quality of our clinical studies. I expect this trend towards more sophisticated technology integration to continue, opening up new possibilities for data collection and analysis in our trials."
Conclusion:
Looking ahead, the field of clinical research is set to experience continuous advancements in technology and data collection methods. We can expect a shift towards more decentralized trial models and a stronger focus on enhancing participant experience and engagement. As these developments unfold, project management in clinical research will evolve to leverage these new technologies and methodologies, aiming to improve both the efficiency and quality of clinical trials.
Here’s a blog featuring insights from our CCO on the future of clinical Research.
Key Takeaways:
- Multidisciplinary Collaboration: From protocol creation to data analysis, clinical research necessitates teamwork.
- Communication: Clear and honest communication is essential to the success of clinical studies, both inside the organization and with sponsors.
- Technological Progress: Efficiency, data quality, and trial management as a whole have all improved with the switch from paper to electronic data recording.
- Project Administration: Aoife Lonergan and other senior project managers are essential in supervising research, leading teams, and guaranteeing that trials are completed on time and under budget.
- Future Trends: Clinical research is anticipated to undergo a transformation characterized by heightened digitization and dispersed trials.
FAQ:
1. How does Atlantia handle communication with sponsors?
Atlantia prioritizes regular communication with sponsors, holding weekly check-ins and sharing updates to keep everyone informed about the study's progress.
2. What are the biggest challenges in clinical trials?
Recruitment and data quality management are two common challenges. Atlantia uses targeted recruitment strategies and continuous quality checks to mitigate these issues.
3. How has technology changed clinical trials?
The shift to electronic data capture has streamlined data management, improved accuracy, and allowed for faster analysis, ultimately improving trial efficiency.
4. What role does Aoife Lonergan play at Atlantia?
Aoife is a Senior Project Manager, overseeing various aspects of clinical trials, from setup to close-out, while ensuring they stay within budget and on schedule.
5. How can Atlantia help with my clinical trial?
Atlantia offers full-service support for clinical trials, from protocol development to final reporting, with a dedicated team of experts to guide you through every step.
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