Bioinformatics, Biostatistics & Software Development
Data Sciences team overview:
Our Bioinformatics, Biostatistics & Software Development team capabilities complement our wet lab operations in every aspect of supporting biomarker-driven clinical trials, as well as providing stand-alone technical services.
At each stage of development or delivery of a biomarker-driven clinical trial, we have established dry lab processes in place to maximise the successful development & delivery of the clinical trial assay. Analysis is standardised and repeatable, and rigorously tested & validated in accordance with regulatory standards.
The team spans three regions (UK, EU and USA) and is comprised of highly experienced scientific experts.
Click on each individual service below to find out more:
- Bespoke NGS pipeline development
- Biomarker/Signature discovery
- Translational signature development
- Assay migration
- Clinical validation
- Support patient lifecycle
- Support clinical assay delivery
- Clinical validation studies
- Analytical validation
- Experimental design
- Software systems development
- Clinical assay software
- Regulatory advice on software
- Protocol establishment
- Software development lifecycle
The bioinformatics team has extensive experience of biomarker discovery from multiple platforms including NGS and microarray for subsequent clinical trial use. Our analysis pipelines are designed to discover, develop and validate biologically / clinically relevant biomarkers with characteristics that enable direct transition to a clinical setting.
The bioinformatics team supports the development of RNA & DNA biomarkers into clinical trial assays by generating bespoke validated pipelines, from raw data processing through to subsequent analytical validation of the biomarkers.
Our biostatistics team offers numerous services, with a specific expertise in using genomics-focused statistical techniques. In addition to data exploration and advanced predictive modelling knowledge, they offer experimental design and analysis support for transition of biomarkers into regulatory environments.
Studies are designed to balance customer and regulatory requirements, while ensuring a high probability of success. The biostatistics team has a wealth of experience progressing clinical tests and are available to advise on many aspects of development & validation activities.
The software development team is a multidisciplinary team of developers and bioinformaticians with the unique skill set required to develop clinical trial-ready reporting software across a wide range of genomic platforms.
Clinical testing reporting software is developed, reported, released and maintained under Almac Diagnostic Services’ Software Development Life Cycle (SDLC), which is certified to IEC62304 Medical device software: Software life-cycle processes standards.
Benefits of Almac data sciences approach:
Having these capabilities available all in one location, through an experienced service provider means a more efficient and streamlined service for clients transitioning a clinical assay from the initial discovery phase through to clinical delivery.
Each stage of the process is designed to ensure subsequent stages are entered into with minimal risks and obstacles.
Data sciences supporting diagnostic development:
Examples of our proprietary products:
Almac Diagnostic Services also invests R&D time into proprietary bioinformatics products to enhance the data output of both DNA and RNA sequencing and analysis. Two such examples are:
- Almac FFPE Artefact Filter: Enhances the accuracy of variant calls from poor quality FFPE samples by removing false-positive variant artefacts and enriching for clinically relevant mutations. Providing clients with a more accurate data readout by effectively removing artefact ‘noise.’
- Almac claraT: A unique software driven solution that classifies biologically relevant gene expression signatures into a comprehensive, easy-to-interpret, interactive report. Featuring all 10 Hallmarks of Cancer.