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Clinical Trial Study Design and Startup: 6 Keys to Success

Learn expert strategies for improving clinical study design and startup.

A speedy and accurate study startup is critical for executing effective clinical trials and bringing life-changing and even life-saving products to market faster. However, with numerous groups involved, each working on individual tasks in disjointed process flows, achieving this can prove difficult. Delays ultimately impact a product’s approval and launch, raising the cost of a clinical trial and potentially delaying the delivery of medicines to patients.

As a clinical trial manager, you must effectively manage complex process flows, multiple stakeholders, and every detail within design and startup while giving careful consideration to the safety of patients. 

Consider these expert strategies for improving the clinical study design and startup.

[Learn more about the challenges in study startup. Download the whitepaper: 3 Challenges Facing Study Startup.]

Clinical trial study design process: 3 best practices.

By optimizing the study design process, sponsors and investigators can help ensure the success of their clinical trials and improve patient outcomes.

    1. Develop a complete and consistent study design plan

    Avoid costly amendments by standardizing plans for reusability across studies and regions. Leverage pre-approved templates to streamline reviews and get plans approved and ready for startup much faster. 

    2. Establish visibility and traceability of key events and decisions.

    Improve transparency across study design planning with a central source for all relevant documents and data. Implement a solution that consolidates disparate data sources to provide a single, clear view of events and decisions to all stakeholders.

    3. Accelerate study planning activities

    Automate tasks and workflows within development of the study plan to expedite time to study startup. Build process handoffs between functional teams into the workflow for streamlined interactions across activities.

    Clinical trial study startup process: 3 best practices.

    Achieving an accelerated study startup will decrease the overall time spent in the clinical trial phase, greatly reducing time to treatment.

    1. Establish clear communication systems and timelines.

    Establishing clear communication systems and timelines among study team members, sponsors, and external partners is essential for ensuring that the study startup process progresses smoothly and on schedule. Prioritizing process visibility and improved digital communication channels can help ensure that all stakeholders are aware of the study's status and can take appropriate action when expected.

    2. Develop a custom workflow.Develop a custom workflow.

    Streamline the startup process by incorporating and driving custom business processes tailored to the unique needs and requirements of the study. Improve collaboration and coordination among study team members, sponsors, and external partners by unifying systems into a single workflow across functions.

    3. Stay on top of regional regulatory requirements.

    Ensure compliance by embedding regulatory requirements into the study startup process. Implement easily configurable workflows that can be customized to account for regional variations in regulations. Staying informed about the specific regulatory landscape in each region where the trial is conducted is crucial to avoid delays and noncompliance issues. By integrating regulatory requirements into the startup process and using configurable workflows, you can ensure that all necessary steps and approvals are properly addressed for each region.

    Automation’s role in clinical trial study design and startup.

    By leveraging automation capabilities across study design and startup, researchers can save time, improve accuracy, enhance regulatory compliance, and streamline communication and collaboration, ultimately accelerating the pace of research and contributing to more efficient and successful clinical trials.

    By using a process automation platform equipped with a data fabric capability, the clinical trial process can be significantly enhanced, leading to the following five key benefits:

    • Enhanced collaboration and communication among cross-functional team members with improved information exchange, leading to more productivity and fewer errors associated with manual coordination.

    • Automated data integration and analysis, allowing researchers to focus more on interpreting results and deriving meaningful insights from the collected data.

    • The ability to easily track contract and document statuses, send automated notifications, and generate reports, reducing administrative burden and improving efficiency during study initiation.

    • Streamlined regulatory submissions and compliance with automated systems that can generate templates, consolidate data, and facilitate document version control, ensuring accuracy and consistency. By automating these tasks, researchers can expedite the regulatory review process and ensure compliance with applicable regulations and guidelines.

    • A complete view of all activities taking place, as well as potential activity trends, to quickly spot bottlenecks or risks before they occur.

    [Learn more about how automation can help across study design and startup with this whitepaper: 3 Challenges Facing Study Startup]