Industry leaders Lyn Mursalo and Randa Wahid share their expertise on effective strategies for global clinical trials. Lyn Mursalo, Director of Clinical Operations at Escient Pharmaceuticals, excels in delivering complex trial protocols and strategic CRO partnerships. Randa Wahid, Senior Project Manager at Indero, formerly known as Innovaderm, brings over 12 years of experience and strategic insights in managing clinical trials across various therapeutic areas.
This article highlights their approaches to maintaining realistic timelines, fostering efficient communication, and building resilience in clinical trials.
Ensuring Realistic Timelines When Coordinating Multiple Sites or International Teams
Randa Wahid
As a project manager, ensuring realistic timelines for clinical trials 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, 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 built into planning. For instance, in Australia, Ethics Committees close between December and January, which must be factored into timelines. Setting expectations upfront is vital. Additionally, international sites have varying holiday periods affecting recruitment timelines. Effective clinical trial communication across time zones and managing vendor timelines are essential. Ensuring all stakeholders are informed and aligned helps mitigate challenges and maintain realistic timelines.
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 Power BI 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. 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 site activation question tracker 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 Wahi
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 assessment frameworks. This involves evaluating the cause, risk, and effect of 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. As project managers, we often want to control everything, but relying on subject matter experts within the company can provide valuable support and insights.
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.
In summary, by leveraging technology and promoting collaboration between sponsors and CROs, Lyn Mursalo and Randa Wahid emphasize the importance of partnership in achieving successful trial outcomes. Recognizing this partnership fosters collaboration and ensures that timelines are met. This understanding has been instrumental in the successful collaborations between Indero and Escient over the past few years.
About Indero
Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at global scale.
