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Welcome to today’s episode as we explore the complexities of global clinical trials with 2 special guests. Lyn Mursalo, Director of Clinical Operations at Escient Pharmaceuticals, has led teams in delivering complex trial protocols and strategic CRO partnerships. With a focus on innovation and efficiency, Lyn ensures that clinical trials not only meet but exceed industry benchmarks.
Randa Wahid, Senior Project Manager at Indero, formerly Innovaderm, has over 12 years of experience managing clinical trials across various therapeutic areas. With a master’s in health care administration, Randa’s strategic insights are key to navigating global clinical trials.
This episode will cover strategies for maintaining realistic timelines, effective communication and resilience and clinical trials.
Ensuring Realistic Timelines When Coordinating Multiple Sites or International Teams
Randa Wahid
As a project manager, ensuring realistic timelines is crucial. During the study start-up phase, we identify our sites and their respective countries. We then consult regulatory agencies in these countries to integrate their timelines into ours. This involves determining submission dates for protocols and necessary documents, approval timelines, and the start dates for patient screening and enrollment. We also account for country-specific factors, including holidays, such as open and close dates for sites. To avoid miscommunication, we ensure all stakeholders are aligned on deadlines and deliverables. This includes creating high-level timelines and more granular ones within cross-functional departments, with regular one-on-one calls to keep everyone on task.
Lyn Mursalo
From a sponsor’s perspective, the leadership team is my primary audience, always concerned with the study results’ delivery timeline. Factors like regulatory agency closures must be taken into consideration. For instance, in Australia, Ethics Committees close between December and January, which must be factored into timelines. Setting expectations upfront is vital. Likewise, with sites, every country has different holiday periods and will experience downtimes, and we need to keep this in mind when looking at our recruitment timelines. Understanding and communicating this is important.
Other challenges include working across time zones, dealing with study team members’ holidays, and when some of vendors are managed by the sponsor instead of the CRO. Ensuring all stakeholders are informed and aligned helps mitigate challenges and maintain realistic timelines. These are important considerations when planning clinical trials.
Addressing and Communicating Cross-Functional Department Details Effectively Between Sponsors and CROs
Randa Wahid
Utilizing technology is pivotal for effective communication between sponsors and CROs. We use tools like Microsoft Teams, SharePoint, and PowerBI to facilitate real-time updates and centralized document access, reducing the risk of miscommunication. Managing meetings effectively is also significant. This involves having a clear agenda, taking minutes, noting action items, and ensuring proper follow-up. We use action item logs and decision logs to track tasks and ensure completion.
Lyn Mursalo
Having a centralized Action Decision Information (ADI) log is essential for documenting decisions and action items, ensuring everyone is on the same page rather than struggling with finding a specific email. A clear communication plan, outlined in our project management plan, specifies who is responsible for communication and maintaining the ADI log. This alignment extends to external stakeholders as well. For our studies, we use a Sites Activation Question Tracker (SAQT) to avoid excessive emails and keep track of site activities. Additionally, strategies for addressing misalignment, such as impromptu meetings, help ensure everyone stays aligned and informed.
Randa Wahid
Regarding the ADI log and email searches, one effective strategy I have used is copying and pasting the subject line into the action item notes. This allows easy reference to the email thread, making it simpler to locate relevant information. Flagging emails can be helpful, but having direct access to the subject line streamlines the process significantly.
Lyn Mursalo
I agree. Additionally, having strategies to address misalignment is important. If issues arise, it’s important to pause and ensure everyone is back on the same page. This may involve impromptu meetings outside of the regular schedule to address urgent matters. Flexibility in scheduling and communication has been vital for our team, helping us stay aligned and save time throughout the study.
Preparing Mentally and Emotionally for High-Stakes Decisions and Setbacks in Clinical Trials
Randa Wahid
Preparing mentally and emotionally for high-stakes decisions and setbacks in clinical trials is paramount. Despite years of experience, each study presents unique challenges. To handle these effectively, we implement a structured decision-making process through risk management and risk assessment frameworks. This involves evaluating the cause, risk, and effect of potential situations, discussing them with cross-functional team members, and developing strategies to present to stakeholders. It’s important to take a step back, breathe, and avoid getting emotionally worked up to maintain a clear and structured approach.
Lyn Mursalo
Understanding the value of your team is essential. Each member brings their expertise, and it is important to seek their support and advice. No one can be an expert in everything. Being prepared for common issues, like patient recruitment challenges, and having strategies in place before crises arise is vital. Taking time for yourself to relax and recharge is also important.
Randa Wahid
As project managers, we often have Type A personalities, feeling the need to control and know everything about our projects. This mindset can persist for years. However, it is essential to recognize the value of subject matter experts within the company. These experts have in-depth knowledge of specific topics and can provide valuable support and insights. Relying on their expertise is essential for effective project management.
Strategies to Maintain a Strong Collaborative Relationship Between Sponsors and CROs
Lyn Mursalo
Avoiding the “them versus us” mindset is central. Both sponsors and CROs are integral parts of the same team, working together towards a common goal. Recognizing this partnership helps foster collaboration and ensures that timelines are met. This understanding has been instrumental in our successful collaboration over the past few years.
Randa Wahid
We view our relationship with sponsors as a true partnership. When sponsors succeed, we succeed. As a CRO, we are motivated by the impact our work has on patients receiving treatment. We are always part of the team, committed to supporting the companies we work with throughout the process.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Indero’s support in your upcoming trial and propel your study to new heights.
