Q&A: Strategies for Successful Global Clinical Trial Delivery

Meeting the demands and deadlines of global clinical trials can be challenging. Realistic timelines, effective communication, and resilience are all essential, but how can this best be achieved? In this Q&A, Randa Wahid, senior global clinical research project manager, Indero, and Lyn Mursalo, freelance clinical research professional, discuss the importance of a strong collaborative relationship between a trial sponsor and contract research organization (CRO), and effective strategies for successful trial delivery.

Wahid: After completing my master’s degree in healthcare administration, I began my career in clinical research and developed a broad understanding of clinical trials through various roles. I was drawn to project management because it combines strategic oversight with problem solving, leadership and cross-functional collaboration, ensuring that all the moving parts of a trial come together seamlessly. I have now been in the clinical research industry for 12 years and joined Indero in 2021, motivated by the opportunity to specialize in dermatology and contribute to global studies that have a meaningful impact on patient care.

Mursalo: I have held various clinical operations and monitoring roles in the pharmaceutical sector over the past more than 25 years. I joined Escient Pharmaceuticals in September 2021 and lead two of its clinical operations programs, which included a first-in-human Phase I study and Phase II trials. During my career, I’ve worked with large pharma, biotechs and CROs, where my roles bridged strategic planning with hands-on trial execution, integrating both logistical and people-focused elements.

Mursalo: While cost is a consideration, a CRO’s ability to bring in experienced investigator networks, niche therapeutic expertise, and a dedicated team often outweighs pricing alone. When evaluating CROs, I typically issue a Request for Proposal (RFP) to a shortlist of three to four CROs with the study outline and expected timelines, and assess their responses with respect to proposed strategies for study conduct and patient recruitment as well as projected budgets. I then request detailed face-to-face presentations to evaluate their team dynamics, scientific expertise and alignment with the sponsor’s values. For smaller sponsors, it’s also crucial to find a CRO that won’t sideline a study in favor of a higher value contract. Working with a specialized CRO can bring immense value; they can suggest the right sites, predict recruitment challenges and deploy monitors who understand the nuances of a particular indication. This makes a tangible difference in trial efficiency and data quality.

Wahid: A strong CRO-sponsor relationship is built on true partnership, shared goals and mutual success—both parties should be aligned in their mission to improve patient outcomes, which fosters commitment and collaboration. Early engagement, joint planning and clear communication establish trust and accountability. Success to me depends on meeting milestones, delivering high quality data and maintaining transparency throughout the process. Relationships thrive when the CRO becomes an integrated and trusted extension of the sponsor’s team, which drives both operational excellence and real-world impacts.

Mursalo: A successful CRO-sponsor relationship stems from recognizing both parties as equal partners working toward a shared goal. Mutual respect, open communication, and a mindset that treats the CRO as a strategic collaborator are key to fostering trust and accountability. This approach encourages joint problem solving and a shared sense of ownership. Continuity in team members also strengthens alignment, helping to maintain progress and cohesion even through shifting priorities or staff absences.

Wahid: Flexibility is key when working across time zones, as is setting realistic expectations that account for country-specific regulatory requirements and import/export considerations for study materials. We also involve regional experts to navigate cultural differences and help tailor communication styles and decision-making processes. To keep global teams and vendors aligned, I rely on structured communication plans, regular status calls and centralized tracking tools to ensure transparency and accountability across all regions.

Mursalo: I agree, managing global trials requires flexibility by all parties. Study conduct is impacted by many regional differences such as regulatory requirements and approval timelines, participant recruitment strategies and availability of resources due to national holidays and staff vacations. Ethics committees in different countries have unique documentation requirements, and accounting for these nuances is critical during trial planning. Teams must also anticipate logistical realities and effectively coordinate across multiple time zones, regulatory environments and cultural expectations for fairness and transparency. For example, in a Phase I oncology trial which I managed, safety reviews were cleared late at night US time, at which time sites in Australia were already online and enrolling the next participant before US sites had the opportunity to do so. This caused frustration for the US sites, even though the protocol technically allowed it.

Wahid: As a project manager, ensuring realistic timelines is crucial. During the study start-up phase, we identify our sites and their respective countries, and 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 open and close dates for sites, and country-specific factors, including national and state holidays. To avoid miscommunication, we ensure all stakeholders are aligned on deadlines and deliverables, which entails creating high level timelines and more granular ones within cross-functional teams, supported by one-on-one calls to keep everyone on track.

Mursalo: In my role I am responsible for orchestrating full trial delivery, ensuring study drug readiness, timely regulatory submissions, and overall operational conduct. This requires alignment across internal and external stakeholders, maintaining regular communication with internal department leads, executive leadership, study vendors, and clinical research sites to support patient recruitment, data quality, and coordinated and on-time project delivery. This is crucial for staying on track and meeting corporate trial timelines and objectives.

Mursalo: Studies involving patient-reported outcomes—like those in dermatology, psychiatry or immunology—require participants to self-report symptoms daily. This introduces subjectivity and data reliability issues and requires careful choice of vendors and close monitoring to ensure robust outcomes. When designing study protocols and planning study conduct adequate consideration must always be given to balancing clinical rigor and patient burden, ensuring protocols are scientifically robust, yet still realistic for patient adherence.

Wahid: Sponsors often have unique reporting needs driven by their stakeholders, which don’t always align with our internal processes. Meeting those needs takes creativity, multiple report iterations and platform adjustments. There's also increasing pressure for real-time data, though it takes time to gather and format accurate reports. Managing sponsor expectations and establishing clear responsibilities from the outset is key, as misalignments are quite common. Global studies also add complexity with varying regulations, time zones, and language barriers, which can make team continuity can be difficult to juggle. I therefore try to ensure that everyone understands the study deeply, and keep core team members consistent to preserve knowledge and cohesion.

Wahid: Early in my career, I was involved in a Phase I CRU study, where several participants began vomiting shortly after dosing, raising safety concerns and creating a visible difference between treatment arms and a potential unblinding risk. We immediately notified the medical teams, documented the events and confirmed safety reporting according to protocol and regulatory requirements. After reviewing the data, the sponsor made the decision to halt the trial. This experience, though challenging as one of my first projects, reinforced the importance of proactive communication and strict adherence to ICH-GCP principles to protect participant safety.

Mursalo: I was once involved in a study testing a transdermal patch for Alzheimer’s patients. Phase I results looked great in healthy young volunteers but, once we started enrolling elderly patients with Alzheimer’s, we found their skin couldn’t hold the patch effectively, and managing dosing compliance became challenging. Many patients couldn’t remember when to change the patch, or were unaware that it was no longer adhered, and caregivers had to be heavily involved. As a result, information on compliance and study drug dosing was inconsistent. We had to work with global teams to rethink how compliance should be tracked, which consumed an enormous amount of time and effort. It was a hard lesson in how differently a product performs in the real-world patient population versus controlled early-phase settings.

Mursalo: Having a centralized Action-Decision-Issue (ADI) log is essential for documenting decisions and action items, ensuring everyone is on the same page. A clear communication plan, across all vendors, is key. The plan should specify escalation points to ensure that unexpected roadblocks can be addressed appropriately and in a timely way. In a recent study we implemented a Site Activation and Question Tracker (SAQT), which helped to minimize emails and allowed all stakeholders to keep track of site activities in real time. Additionally, strategies for addressing misalignment—such as impromptu meetings—can ensure that everyone gets back on the same page quickly, saving time throughout the study.

Wahid: I focus on open communication, empathy and clear prioritization. Regular check-ins and reinforcing our shared goals keep the team aligned and motivated. Using technology is also pivotal for effective communication between sponsors and CROs; we use tools like Microsoft Teams, SharePoint, and Power BI to enable real-time updates and centralized document access, reducing the risk of miscommunication. Managing meetings effectively is also important to resilience, and this involves having a clear agenda, taking minutes, noting action items, and ensuring proper follow-up using the ADI log to track tasks and ensure completion.

Wahid: Bottlenecks often occur at handover points, for example, between functions or during site transitions. Clarifying ownership and setting realistic timelines are essential to smooth these out. Project management platforms and shared document repositories have greatly streamlined our international communications, while real-time dashboards provide clarity on progress and risks.

Mursalo: The shift to electronic case report forms and cloud collaboration platforms has transformed how the industry works. Data is entered and verified in near real time, and teams across continents can review documents simultaneously, track recruitment dashboards and respond to safety signals faster. Even with these tools, resolving data queries is still a common bottleneck, as it relies on busy site staff answering questions correctly and promptly, and misinterpretations or incomplete responses delay database lock. Until we move to fully automated or artificial intelligence (AI)-driven data validation, this will remain a challenge.

Wahid: I see AI as a powerful tool for improving efficiency and addressing many challenges in clinical research. That said, regulatory bodies may face difficulties in issuing guidance and validating certain AI-driven processes, since the technology is still relatively new to the industry. For day-to-day tasks, I believe AI will enhance collaboration, reduce errors and enable faster responses to sponsor needs. I also see the potential for AI to significantly improve patient recruitment and retention by enabling smarter site selection, better targeting and more personalized engagement strategies.

Mursalo: I also believe that AI will revolutionize how we design, run and analyze trials. Generative AI tools are capable of outlining draft protocol or informed consent templates based on public databases. Data review, safety signal detection and even patient engagement will also become faster and smarter with AI. That said, we must constantly re-evaluate what roles must remain human driven, especially those that rely on judgment and empathy.