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Steps to Effective Clinical Study Management

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Streamlining Clinical Study Management

At ACM Global Laboratories, we understand how overwhelming it can be when thinking about all the steps to effective clinical study management. Our expert project managers help at every point in the process. The project manager plays an essential role in planning the work required for a clinical study, maintaining the study with regular reporting and communication, identifying and mitigating risks, and ensuring study milestone success.

Here are the key steps that project managers take to ensure successful clinical trial management:

1. Startup Phase

The startup phase of a clinical trial typically involves the first two-four months depending on complexity. During this time, the project manager’s primary goal is to establish effective communication, alignment of the project's scope, identify potential risks, and completion of key documentation for the trial. The startup phase of clinical study management will include the following:

Kickoff Meetings

The project manager will conduct several kickoff meetings to begin the startup process. The first meeting is between the project manager and the client and will involve introductions and a review of the study scope and timeline for the trial. The project manager will also explain ACM’s protocols and processes and bring up any identified risks based on preliminary review or lessons learned from previous clinical trials. The goal of this meeting is to achieve total alignment between the client and the project manager.

Once the project manager and the client have achieved alignment, a second kickoff meeting will occur between the project manager and their ACM operational teams. During the internal kickoff meeting, the project manager brings operational team leaders together to review the scope and timeline. The internal kickoff meeting is a time to educate on the study scope, timeline, resource alignment and raise lessons learned to help ensure successful clinical study management.

Documentation

After the initial kickoff meetings, the project manager will begin executing important startup activities. These include drafting the global laboratory specifications document (GLSD) with the support of a dedicated professional medical writer. This foundational document details all aspects and specifications of central lab responsibilities based on the clinical protocol. The project manager will also develop the lab manual, outlining what tests should be collected, what the content of the collection kits are, and how they should be packaged, handled, and shipped to ACM that will be shared with each of the site participating.

Customized Kits

Once the GLSD is approved, the project manager will collaborate with our Setup team to load the trial specific information into our lab management database. This is one of the lengthier processes, as it requires customization for each trial and a robust validation/QC process in order to ensure compliance on requisitions, testing, and reporting. Once the database set-up is complete, the kits, including the lab manual, are shipped to the participating sites supporting the trial. These sites can then enroll patients from a lab prospective for the clinical study.

2. Maintenance Phase

The maintenance phase is a significant part of clinical trial management and has the longest duration. The goal of this stage is to maintain open communication with the client through continuous checkpoints to ensure the success of the clinical trial. The project manager’s role during this phase involves:

  • Tracking the progress of the trial
  • Tracking what ACM has received
  • Monitoring the status of all collection samples
  • Coordinating sample shipments as needed
  • Budget management
  • Addressing any open items
  • Continuing to identify and monitor risks

Since this is the longest phase of the study, the project manager will set up regular meetings with the client to ensure that the clinical trial stays on track, promoting open communication and transparency. 

3. Closeout Phase

The closeout phase is the clinical trial process's final stage and we encourage a dedicated three months to ensure success. During this time, the project manager along with the dedicated data manager verifies that all patient samples have been collected and processed. They also reconcile issues, ensure data integrity, and data alignment across study databases before delivering a final data transfer. At the end of the process, project managers will also coordinate the sample storage expectations, whether to continue storing them, destroy them, or ship them onward.

The Benefits of Working with a Project Manager

There are many benefits to working with a project manager for your clinical study management, including:

  • Stay within budget: The project manager will monthly share a budget plan with the client. They will include itemized key elements of the laboratory budget and a list of what has been spent and what is remaining. During regular checkpoints, the project manager will work with the client to make any necessary revisions to the budget based on protocol amendments.
  • Maintain a timeline: There are many causes of delays to the clinical trial timeline. However, project managers are highly experienced in understanding how to avoid certain delays, manage timeline expectations, and make necessary adjustments to ensure that the trail remains on track.
  • Ensure accurate reporting: Project managers keep an activity log that captures the entire life of the clinical trial study, including key actions, decisions made, quality performance, potential and actual risk, and other important elements.
  • Mitigate risks: Project managers are focused on risk mitigation and leveraging prior experiences. The project manager will work with the client to help them become more aware of these threats and what they can do to avoid or recover from them. Through continuous project plan monitoring, active collaboration, and constant and transparent communication, project managers can manage known and unexpected risks to a clinical trial. When problems arise, the project manager will work with the client to determine the impact, develop a response plan, and monitor the issue.

Partnering with an ACM Project Manager for Clinical Study Management

By partnering with a project manager early in the clinical trial process, you can ensure better communication and alignment throughout the management of the clinical study. According to ACM’s Vice President of Clinical Study Management, Ashlee Verrioli, “The project manager can be seen as a direct extension of our client’s team, acting as their number one advocate as they navigate the clinical study management process.”

At ACM, our project managers are dedicated to assisting you through the clinical study management process and helping you achieve your clinical trial objectives. Contact ACM Global Laboratories today to partner with a project manager for your next clinical trial.