Almac Diagnostic Services can provide access to our expertise and experience as a consultancy service to support your biomarker strategies.

We offer a comprehensive consultancy service for clients to help guide your precision medicine program, whatever stage of the drug development journey you are at.

These services can be provided as a standalone bespoke consultancy agreement.

Our consultancy service includes:

Bioinformatics

Bioinformatics is a critical component and often a primary bottleneck in biomarker discovery and validation. Almac Diagnostic Services offers a bespoke bioinformatics consultancy service which can guide your biomarker studies from study planning right through to final analysis and delivery of a validated biomarker. Find out more

Biostatistics

Our Biostatistics team offer a rare combination of statistical and genetic expertise, providing clients with optimal strategies and solutions in the molecular diagnostics field. Much more than a traditional group of analysts, our biostatistics team help ensure that the assay meets client’s exact customized needs, that studies are designed to ensure success while minimizing cost, and that the right analyzes will be chosen to facilitate appropriate characterization of the assay. Find out more

Software Development

Our software solutions team has expertise in automation of data processing, instrument integrations, analytical run validity verification, quality control assessments and facilitating patient test reporting. Working closely with clients to identify and refine key requirements at an early stage using a risk based approach to tailor robust solution to meet their exact needs, whether this is biomarker software for testing under CLIA lab regulations, CTA or CDx. All development and validation work is performed with strict adherence to latest regulatory standards.

Almac has extensive experience developing software solutions for RNA and DNA based qPCR and NGS assays. We also have considerable experience developing integrations with cloud platforms and other remote systems using APIs. Find out more

Regulatory Support

Almac Diagnostic Services regulatory affairs team has extensive experience in engaging with global regulatory authorities such as US (FDA), EU (MHRA). In addition, we can help you engage with China (NMPA) through our local Chinese agent. We can guide you throughout the Clinical Trial Assay (CTA) and Companion Diagnostic (CDx) lifecycle, drawing on an in-depth knowledge of molecular diagnostic product development. We provide invaluable support to our clients from the investigational clinical trial phase through to the post-market phase, resulting in successful regulatory submissions and ultimately a fast and efficient path to market. Find out more

IVDR – Almac can also give Pharma partners up to date guidance and support for your biomarker programs around IVDR and compliance with the new regulations for Europe.

Almac Diagnostic Services has updated all CTA and CDx processes to be compliant with the new IVDR. We have ensured any legacy devices CE marked under the IVDD are maintained in such a manner as to be available throughout the transition period to allow trials to continue seamlessly despite changes from the previous directive to the IVDR.