Clinical Trial Assay Development

Almac have extensive expertise in the development of CLIA validated clinical trial assays. We have developed RNA, DNA and protein based clinical assays on a wide range of platforms and we are currently supporting a large number of biomarker-driven clinical trials globally.

Whether we carry out the biomarker discovery ourselves, or you come to us with biomarkers of your own, we can develop them into clinical assays.

The process of developing a discovered biomarker into a test for clinical delivery is complex, but it is an area in which we have significant experience.

Our key area of expertise is in the development and delivery of multiplex RNA and DNA based tests however our assay development and delivery services are not limited to multiplex assays and we offer a wide range of platforms for delivery of DNA, RNA and protein assays.

Clinical Trial Assay Development Services 

  • Determining the optimal platform for delivery of the assay
  • Platform migration
  • Tissue migration studies
  • Assay transfer and appropriate analytical or method validation for clinical delivery
  • Proprietary panel of qPCR reference genes
  • Developing the assay instructions for use (IFU) and generating appropriate reference samples for use in validation studies or clinical delivery
  • Verified and tested software to automate the production of test reports from raw test data (including algorithm analysis and QC)
  • Test interface and report
  • Analytical validation of the assay to CLIA standards, establishing assay threshold, analytical precision, reference

Early Phase Trial Enrichment Strategies

Once the biomarker has been developed into a clinical test, we offer centralised clinical testing for trial enrichment in early stage trials (under CLIA for US based trials and GCP for the rest of the world). We also offer testing on multiple platforms, with the rapid turnaround time required to support the decision making process in trial recruitment.

The key components of our clinical testing service include:

  • Distribution of sample collection kits to clinical sites
  • Production and control of trial-specific documentation (including test requisition and an operations manual)
  • 24/7 sample receipt
  • Pathology review (if required)
  • Independent diagnostic confirmation (if required)
  • Multiple testing platforms
  • Patient test reporting to clinical sites
  • Regular clinical trial data delivery to sponsors

Trial Setup and Management Services

In addition to the clinical trial assay development and delivery, we can support the biomarker component of the clinical trial. Our trial setup and management service includes:

  • Requirements gathering and SOP development
  • Operational manual development
  • Site training
  • Site audit
  • Sample shipping
  • Sample logistics
  • Central admin
  • Project management support

We offer dedicated project management support. All of our project managers are experienced in managing clinical biomarker studies and have extensive experience working directly with clinical sites. There is a 24-hour helpline and we can receive clinical samples 24 hours a day, 365 days a year.

8 years developing custom client assays

Extensive experience with RNA and DNA based multiplex tests

Over 60 assays developed on a range of platforms

Over 100 clinical trials analysed

 

Related resources