What Happens During the Maintenance Stage of Trial Management?

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What is the Maintenance Stage of Trial Management?

Clinical trial management involves three stages: startup, maintenance, and closeout. The maintenance stage of clinical trial management is the longest of the three stages. During the maintenance stage, the project manager focuses on making any necessary adjustments to the scope, timeline, and budget, mitigating risks, and preparing the final data to determine if the drug or therapy is working as intended. Maintenance is vital to the trial management process because any unforeseen issues could result in delays or added costs. During the maintenance stage, the project manager will continue to monitor the trial to help ensure that it is a successful one.

Read more about the steps to effective clinical trial management

What Occurs During the Maintenance Stage?

The maintenance stage begins after the study startup has ended. Before beginning maintenance, the project manager will help clients build their budget, design their protocol, and initiate important documentation. The startup stage typically involves the first two to four months of the trial management process. During this time, the project manager will hold several kickoff meetings to become introduced to the trial, establish communication, and achieve total alignment. They will then complete the documentation process, including drafting a global laboratory specifications document (GLSD) and developing the lab manual. At the end of the startup stage, customized kits will be sent to the designated study sites where patients can begin enrollment and maintenance begins.

Read more about what's involved involved in the study startup stage

The maintenance stage can last anywhere from six months to ten years or more, depending on the scope of the trial. However, the average length of the maintenance stage is two to five years. During this time, the project manager will set up various checkpoints to ensure a successful clinical trial and work with the client on the following:

1. Continuing Review

During the maintenance stage of clinical trial management, the project manager will continue to review the scope of the trial to ensure that everything remains on track to completion. They might need to adjust timelines, budgets, and goals based on potential risks and other factors.

2. Tracking Progress

The project manager will track the trial’s overall progress, what data ACM has received, the status of all collection samples, and the status of any shipments. Regular meetings are an essential part of the maintenance stage to promote continued communication and transparency regarding tracking the trial’s progress.

3. Data Management

Data cleaning and management are the most critical parts of the maintenance stage. Clients must continuously clean data throughout this stage instead of waiting until the final data transfer to avoid going over timelines. Having to adjust timelines after a trial has already started can result in potential consequences such as added costs.

4. Data Resolution

Before the closeout stage, project managers will work with the client to ensure that all data is gathered from collection sites, is accurate, and is transferred successfully.

After the maintenance stage, the closeout stage will begin. During this final stage, the project manager will verify patient samples, ensure data integrity, and reconcile any outstanding issues. They will also work with the client to coordinate sample storage, either continuing to store them, shipping them onward, or destroying them. The closeout stage encompasses the final three months of the trial management process.

Maintenance Stage Milestones

The maintenance stage is mainly about ensuring that the trial stays on track. However, there are some important milestones to work toward during this stage, such as fulfilling enrollment criteria. Some enrollment milestones include:

  • Hitting initial and completion enrollment rates
  • Making sure that every subject enrolled in the study has what they need
  • Ensuring that subjects remain in the study for the full duration

Another key milestone during the maintenance stage is receiving enough data to determine that the drug or therapy is working as intended. To do this, it is crucial to ensure that samples are sent as soon as possible to gather as much data as possible. This allows the project manager and client to see how the drug is functioning and determine if they can report to the FDA that it is doing what it should.

Potential Maintenance Stage Roadblocks

With every stage of clinical trial management, there are some potential roadblocks to be aware of. During the maintenance stage, common roadblocks include:

  • Not being able to find enough individuals to participate
  • Not being able to pull enough data from subjects
  • The drug not doing what it is supposed to be doing

The project manager can help mitigate these risks and navigate potential roadblocks throughout the maintenance stage. ACM’s Associate Director of Project Management Regina Harrison explains, “As a project manager, we can help by providing regular enrollment updates, understanding when collection kits need to go out, and ensuring that there are no data inconsistencies.” Harrison also stresses the importance of regular meetings throughout the maintenance stage to continue effective communication.

The Role of the Project Manager During Maintenance

The project manager plays a vital role in every stage of the clinical trial management process. By working with a project manager, you can ensure that your trial remains within budget, avoid delays, and mitigate potential risks throughout the maintenance stage. Working with a project manager throughout the entire clinical trial management process can lead to improved communication and alignment. 

ACM Global Laboratories can connect you with a project manager to support your next clinical trial. Our project managers act as an extension of your team to help ensure successful study management. Get started with ACM today. 

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