Ancillary supplies and equipment are fundamental parts of every clinical study. The entire process, from identifying and procuring protocol-compliant supplies and equipment to getting them to their international destinations is both a science and an art.

But that’s really just the beginning. Monitoring and controlling your equipment and supplies is a proven project management process that should be actively ongoing throughout your trial.

What do I mean by monitoring and controlling? It involves these actions:

• Tracking, reviewing, and regulating the progress and performance
• Identifying any areas in which changes to the plan are required
• Initiating the corresponding changes

Monitoring and controlling is especially important because it gives you the ability to course-correct whenever necessary. Here are three essential monitoring and controlling tips.

Tip 1: Advance planning for problems that may arise

It’s human nature to put a plan together with the optimistic expectation that you’ll just handle any issues if and when they arise. But this is short-sighted because issues can cause huge and costly delays in your trial and you have to be ready to respond quickly.

Planning should include careful consideration of problems that could come up, as well as the process for acting on them. That process must address these questions:

• What is the review process if there are problems?
• What is the communication plan?
  • Who gets notified?
  • Who is responsible for resolving?
• What is the escalation plan to get a resolution in place?

Recognizing potential problems early is critical to driving resolution so that timelines, costs, and risks are minimized. An established plan that identifies the team members and the roles they will play to address problems will help you hit the ground running.

Tip 2: Managing considerations

Once you get the supplies and equipment to your sites, it doesn’t end there. Management is necessary, and one of the considerations is your product replacement plan.

Here is an example of the need for attention to detail. A min/max thermometer calls for a completely different replacement plan than, say, the scheduled calibration of a scale at a site.

If your study duration is two years and your min/max thermometer is good for 12 months, it will likely need to be replaced. Making sure in advance that you have a plan to replace it will prevent a gap in monitoring refrigeration of medication at the site.

Similarly, planning for the calibration of a scale will make sure the site continues to operate seamlessly. Is your plan to have a technician on site calibrate the scale? Or is it best to have a replacement scale sent prior to the scale’s calibration expiration? We prefer to contract or repair through local contacts near the sites, especially with larger items. Smaller items can be easily shipped, and we often opt for what we call a repair/replace—we send a replacement that is calibrated, and the site returns the used device.

(These considerations should be part of your upfront planning, which includes weighing the pros and cons of rent vs. buy, a topic we covered in a recent blog post.)

Tip 3: Getting ahead of amendment requirements

Protocol amendments happen! We have seen them on many trials—sometimes six, seven, and even eight during a trial. Amendments are costly. Planning ahead can help mitigate some of those costs.

If you know that an amendment is imminent, start planning before the amendment is final. Understanding the changes that are expected to be implemented, and specifically how those changes affect the processes and procedures that require ancillary supplies and equipment, will position you to make proactive decisions about supplies that may now be necessary for study conduct.

Our ebook is free

You’ll find further details about monitoring and controlling (and four more important steps) in Imperial’s ebook called “Ancillary Supplies and Equipment for Clinical Trials, A Project Management Approach.” Our ebook explains how to apply a proven and practical step-by-step process to make it easier for you to identify and implement ancillary supplies and equipment needs for your trials.

Our ebook is free via this link. I hope you will get your copy and apply our practical processes to your trial.