5 Steps for a Smooth Transition When Your Clinical Study Needs a Rescue
Things don’t always go according to plan when you’re conducting a clinical trial. From sudden shifts in timelines to unexpected resource constraints or challenges with partners, these unexpected turns can lead to significant delays, jeopardizing the timely collection of critical data that is essential for your trial’s success. Such moments call for tough decisions, including the possibility of transitioning your trial to a new lab partner. But how do you know when it’s time to make the shift?
Signs Your Clinical Trial Needs Rescuing
When things aren’t running smoothly in a clinical trial, it can be difficult to determine the right time to make a change. Whether you’ve been trying to manage all the testing logistics across multiple labs or have a central lab vendor, you should watch out for these 4 red flags that may be a signal you should consider seeking a new central lab for your study:
- High incidence of missing or lost samples
- High incidence of testing cancellations
- Inability to get lab kits on-site on time
- High sample collection errors due to complex testing
Planning for Your Study Transition
Planning for the transition of a clinical trial study requires a strategic and systematic approach to address the challenges and complexities involved. Significant delays in the clinical trial process have most likely already begun, and it’s crucial to swiftly and efficiently regain as much momentum as possible.
If you suspect your clinical trial requires rescuing, consider taking the following steps to ensure a smooth transition to a new central lab partner.
Step 1 – Assess the Situation
Conduct a comprehensive assessment of the trial’s current status, identifying the root causes of any issues or challenges encountered. This may involve reviewing trial protocols, data quality, regulatory compliance, resource allocation, and timelines.
Step 2 – Develop a Plan
Based on the assessment findings, develop a detailed rescue plan outlining specific actions and timelines to address identified issues and mitigate risks. This plan should include strategies for improving patient recruitment, data collection and analysis, regulatory compliance, and stakeholder communication.
Step 3 – Engage Regulatory Authorities
If necessary, engage with regulatory authorities to discuss the challenges faced and seek their input or approval for proposed rescue efforts. Transparency and collaboration with regulatory agencies are important for ensuring compliance and expediting the rescue process.
Step 4 – Allocate Resources
Allocate sufficient resources – including personnel, budget, and technology – to support the implementation of the rescue plan effectively. Consider whether additional expertise or support such as functional service providers may be required to get things back on track once the new timeline is in place.
Step 5 – Communicate Transparently
Maintaining transparency between central lab partners during the transition process helps to ensure a smooth and successful handover. Clear and open communication about timelines, data transfer protocols, and quality assurance measures will foster collaboration between both parties. Providing comprehensive documentation and facilitating regular meetings or updates can further enhance transparency, minimizing disruptions for all those involved.
Getting Your Clinical Trial Back On Track
When searching for a central lab partner to rescue your clinical trial, ensure that they are able to provide your study with everything you need to get your trial back on track. A comprehensive action plan should be developed, outlining the steps required to address the existing challenges and mitigate any further risks. This plan should include recalibrating timelines, establishing clear communication between all stakeholders, and ensuring the seamless transfer of data and samples to the new lab.
Both central lab partners should be encouraged to share insights, best practices, and lessons learned to optimize processes and outcomes. Ongoing monitoring and feedback can help identify and address any issues at hand, ensuring that collaboration remains productive and beneficial throughout the transition.
Introducing the Rapid Intervention Team
At LabConnect, we understand it’s impossible to anticipate every possible scenario. That’s why we assemble a specialized team of experts to intervene when unforeseen circumstances arise. We call it the Rapid Intervention Team (RIT). Whether you need a sudden influx of expertise to help your team navigate unanticipated challenges, or you need a steady hand to take over responsibilities from another vendor, the RIT will rapidly assess your situation and create custom solutions to ensure your clinical trial keeps moving.
A Real-World Study Intervention
A biotech company that had initially partnered with a reputable laboratory testing services provider noticed a red flag in their clinical study. Their central lab partner had recently implemented a new Laboratory Information Management System (LIMS) which was leading to significant errors in sample management, raising concerns about data accuracy, missed shipments, and sample stability. Recognizing the urgent need for intervention, the biotech reached out to LabConnect, prompting our Rapid Intervention Team to take immediate action.
Our experienced project managers swiftly assessed the situation and devised a comprehensive plan to address the challenges. Leveraging customized data integration solutions, LabConnect collaborated with the client to establish protocols for re-accessioning and transferring sample data from the previous vendor to our database. Subsequently, we transitioned the storage of these samples into LabConnect’s biorepository, ensuring immediate access, enhanced data stability, and reliable shipment processes.
This streamlined approach not only reduced queries from testing labs but also expedited testing and query resolution timelines. Additionally, recognizing the value of real-time digital tracking services, the client ultimately upgraded to LabConnect’s advanced tracking system, a feature unavailable with their previous lab partner. Through proactive intervention and tailored solutions, LabConnect successfully remedied the challenges faced by the biotech company, reinforcing our commitment to delivering seamless and innovative laboratory services.
To learn more about potential flags that may put your trial at risk and to see how LabConnect’s Rapid Intervention Team can help get your clinical trial back on track download our Rescue Study Model today!