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In the complex world of clinical research, it’s essential for sites to streamline study start-up processes to better meet their timelines, ensure trial success, and improve financial performance. From coverage analysis to contract execution, each step along the study start-up continuum has unique challenges that require strategic approaches to improve efficiency. This blog will explore the common causes of study activation delays and share strategies for streamlining study start-up processes for research sites and institutions.
Understanding the Causes Behind Study Start-Up Delays:
Start-up delays at sites can occur due to a variety of reasons, including communication barriers, inadequate staffing and resource limitations, and contract and budget negotiations, as aligning the interests and expectations of involved stakeholders often requires extensive time and revisions. Furthermore, administrative bureaucracy, staff training requirements, and local regulatory approvals may exacerbate delays at sites.
How Trial Complexity Impacts Start-Up
Study start-up timelines are often impacted by the complexity of clinical trials. Factors such as trial phase, therapeutic area, and protocol design can create additional hurdles during start-up. Regardless of the trial phase and indication, start-up and activation processes require careful planning and coordination across multiple teams and departments, which can make it difficult to streamline processes and eliminate delays. For trials with complex protocols, such as those in oncology, these complexities can exacerbate already long start-up timelines.
Varying Study Activation Timelines by Site Type
Across all therapeutic areas, there is disparity between site types in median time for trial activation, defined as time from site selection to completion of contract. For the past three years for Phase I-III trials, the median timeframe for trial activation is 9.4 months for academic medical centers (AMCs) and hospitals vs. 4.8 months at independent sites/physician practices.{1} This discrepancy in start-up timelines can be attributed to several factors. AMCs and hospitals often have more complex administrative structures, legal departments, and compliance checks, which can prolong the time required for contract negotiations and approvals.
Strategies to Address Start-Up Delays and Improve Timelines
To address start-up delays, it is crucial to establish a target timeline goal, map out your site’s entire study start-up process, and set expectations with everyone involved. This includes documenting each handoff, identifying all necessary review points and approvers, and making efforts to reduce unnecessary delays and whitespace. By following this process, sites can better identify bottlenecks and develop strategies to streamline start-up.
Establishing Study Start-Up Goals and Setting Expectations
Before your site begins to work toward improving start-up timelines, it is important to establish goals and target timelines that everyone can align to. Whether your site is aiming for start-up timelines under 90 days, 120 days, or more, getting stakeholder buy-in and setting expectations with everyone involved in the process is a crucial first step.
Mapping and Standardizing the Entire Process
Creating a detailed and standardized map of the entire start-up process for your site is invaluable. This map should encompass each handoff, reviewer, and approver for every process, from budget and contract negotiations, coverage analysis, and contract execution, to financial entries in the clinical trial management system. It’s crucial to map each component thoroughly. By understanding the entire process, your site can better identify bottlenecks, work to improve them, and avoid future delays. Additionally, it’s important to regularly update this map and discuss roadblocks with the staff responsible for each step to foster a culture of continuous improvement.
Addressing Whitespace
Whitespace (the time spent waiting for handoffs, reviews, and approvals) can significantly impact start-up timelines. Identifying valid and invalid whitespace is essential. Valid whitespace includes necessary approvals and reviews that ensure quality and compliance, while invalid whitespace means unnecessary delays, such as critical documents sitting in an e-mail inbox for weeks. By identifying where your site has valid and invalid whitespace in your study start-up process, you can potentially eliminate weeks or months of unnecessary delays.
Improving Communication to Mitigate Delays
Improving internal communication among your site staff and enhancing external communication with your sponsors, contract research organizations, and service providers can significantly reduce start-up timelines. Clear and consistent communication between all stakeholders is crucial. By fostering a collaborative environment and ensuring that all parties are well-informed, research sites can expedite start-up, ultimately leading to more efficient trials.
Conclusion
In today’s complex clinical research environment, streamlining the study start-up at your site is more important than ever. By understanding the common causes of start-up delays and implementing strategic measures to improve timelines, sites can foster greater efficiency while promoting collaboration and consistency, ultimately paving the way for more successful clinical trials.
If your site is struggling with study start-up delays and long activation timelines, WCG can help. In 2024, we supported more than 2,200 trials with our study start-up solutions, and our experts are here to support your site’s goals. Discover how we help sites accelerate their trials and drive research to results today.
Sources:
- WCG ClinSphere(TM), 2025
