CLINICAL TRIALS

Pinpoint answers with better data

In the clinical trial industry, countless decisions are based upon laboratory data. Without proper systems in place to ensure the accuracy of that data, it becomes incredibly challenging to draw quick and meaningful conclusions.

CEQAL provides a host of services to assist clinical trial groups and their partner labs deliver a more accurate and more efficient drug approval process from start to finish. By identifying potential sources of laboratory error along the way and implementing solutions to correct it, CEQAL can help you find the right answers sooner, saving valuable time and money.

LABORATORY AND PATIENT QUALIFICATION SERVICES

We can help set you up for success by auditing the testing accuracy of your labs and ensuring the right participants are enrolled. This helps eliminate problems downstream by minimizing the sources of error that can contribute to variability in testing throughout your trial. It also reduces the chances of false positives and false negatives in patient selection, leading to faster recruitment and better relationships with doctors and patients. When quality of data is emphasized over quantity, it is also possible to make quicker decisions with fewer participants, effectively streamlining your trial process.

HARMONIZATION OF TESTING WITHIN LAB NETWORKS

From our experience, there is often a tremendous amount of ‘noise’ or variation in data from lab-to-lab within a global clinical trial effort. Compounding this problem is the sheer volume of tests required every day. This makes it extremely challenging to draw meaningful conclusions from the data and make good decisions quickly. CEQAL can provide quality controls and accuracy audits to help pinpoint problems and correct them. We can also assist in harmonizing data and reducing ‘noise’ through post-analytical normalization. Or in simple terms: we can make your data make sense.

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ACCURACY ASSESSMENT OF CRITICAL ANALYTES AND SAFETY TESTS

Nothing is more important than accurately monitoring the analytes most critical to your study. This data ultimately answers the question: is the drug or therapy working? Or equally as vital: is it safe for the patients involved? CEQAL has a wide range of accuracy-based samples that can help you answer these questions quickly and decisively. See our samples table for a list of analytes within our current catalogue. Note: We can also design customized sample sets depending on the nature of your trial.

COMPLETE STANDARDIZATION

For those seeking the most comprehensive solution, CEQAL can serve as a partner in the design and implementation of your entire study. We can work together from the outset to create a customized solution completely tailored to the objectives of your trial. We can help define clinically relevant performance standards for your trial and monitor the quality of biomarker testing over time. We can help standardize the tests within your lab network by tying them to target values set by internationally credentialed reference methods. And, upon completion, we can provide you with detailed performance reports verifying the quality and accuracy of your trial.