Preparation For Biotech Testing Or Clinical Trials

By Alexander Watt, Global Head, Q2 Solutions Biotech

Your clinical trial may involve samples from multiple sites to be tested by multiple laboratories. The data that flows from those tests may travel to multiple end users as well. Proper planning of sample, testing and data timelines helps ensure that everything can happen on schedule. Here are some considerations to make your trial run smoothly.

Analytical testing requirements

Understanding the analytical landscape for the protocol is essential. What services, e.g., safety testing, diagnostic or exploratory biomarker analysis, pharmacokinetics or pharmacodynamics, etc., are required from your laboratory vendor to support the needs of the protocol?

Knowing which labs will be doing the analysis and what the data will be used for and when is also important. How the data will be used defines the validation requirements for the assays as well as the qualification and certification levels for the labs that are involved in the research. Are there any custom requirements that need to be discussed in advance?

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