By Amity Allman, VCT Project Manager

6 ways to set up your study for success

Are you launching a pilot study or a pivotal veterinary clinical trial? Important details can be easily overlooked in the mad rush of starting a new trial. This can ultimately lead to delays in regulatory submissions and drug approvals.

Our team helps clients in a variety of ways to ensure that your trial is running smoothly – from the start. To do this, one of the most critical aspects of an accurate and successful study is in the pre-study phase. The following are considerations for working collaboratively with your lab partner to get your study off on the right foot:

1. Select a central laboratory - Using a central laboratory for a veterinary clinical trial comes with many advantages: streamlined data, a single point of contact for all your study needs and access to depth of expertise.

2. Review protocol, pre-study – At IDEXX BioResearch, we ensure final study protocols are reviewed by a clinical pathologist, Quality Assurance personnel, laboratory staff, your Project Manager and Account Manager to ensure we understand the study flow and can support the desired outcomes. This is critical to allow time for any questions to be resolved before your study is underway.

3. Organize and customize to streamline collection – Every part of our sample collection kit is customized. By making it easier for sites to understand what samples should be collected, how they should be shipped and what results should be received during each phase of the trial, the study is more likely to run smoothly and on schedule.

4. Ensure timely results delivery – Some studies have critical timepoints for enrollment and dosing. As a laboratory we understand that timely results are critical for a study quickly reaching target enrollment. We also realize that a time machine doesn’t yet exist that can teleport samples from the investigator clinic to our sample processing team in less than two minutes. Therefore, we routinely work with clients to craft sample collection schedules so our lab staff and site investigators have clear expectations as to when results should be available.

5. Consider data management – The use of EDC (Electronic Data Capture) systems for veterinary clinical trials is growing in popularity. IDEXX BioResearch has invested in data connectivity to create an automatic, validated data flow into EDC systems.

6. Prioritize data integrity – Along with the flow of data, we work with study sponsors to create naming protocols that easily allow for samples to be identified throughout the study, resulting in fewer amended reports. This reduces the “Fluffy Johnson” vs. “Fluffie Johnston” conundrum.

By taking the time to focus on each aspect of study set-up, our clients find their trials run smoothly and efficiently, resulting in quicker regulatory submissions and drug approvals.

Questions? Ask our experts.

Talk with our team about partnering with IDEXX BioResearch for your next veterinary clinical trial. Fill out the form on this page, and we’ll be in touch soon to answer your questions.