Overview

Home-WelcomeWe combine meticulous detail with deep experience to enable successful clinical trial biomarker testing. Experience our quality practices through our documentation, contingency planning, project manager appointments and operating procedures.

HistoGeneX has performed over a thousand clinical trials, many of which are global. This experience is rigorously shared through the organization to ensure that our experience translates to smoother operations and that we can anticipate trouble spots and proactively mitigate against them.

 

 

What experience does HistoGeneX have with early and late phase trials?

HistoGeneX offers comprehensive pathology and biomarker assessment services for Phase I-III clinical trials. This includes time-sensitive patient selection and stratification in addition to exploratory projects in batch testing mode. We design our assay validation and development services to transition seamlessly to clinical trial work.

What is your experience with multi-site global clinical trials?

Our laboratory has worked with global multi-site trials for over 10 years. Our experience with tissue biomarker assessments in clinical trials is extensive, and we have carefully captured the best practices for our operations. Our team will gladly provide input for clinical development plans and offer guidance on appropriate specimen collection.

What is your capacity?

We routinely manage Phase I-III multi-site global projects. We combine well-defined processes with rigorous planning to manage capacity.

What is your turnaround time?

HistoGeneX monitors and adheres turnaround time requirements with specific diligence. We will establish this metric with you which depends on the specimen type as well as the technology that is utilized.

Are your pathologists board-certified?

Yes. Our board-certified pathologists are located on site with us and review your slides. Their diverse backgrounds cover various subspecialties in both research and clinical settings. Our close association with the Middleheim Hospital, Antwerp allows us to access important resources and knowledge.

Will you be able to send reports to clinical sites?

Yes. We will customize report forms for your clinical sites. We will also deliver compiled data to you through your defined portals and secure formats.

What type of testing do you offer?

We offer a wide variety of testing and assay development that are described here