Supporting Services
Supporting Services Overview
Almac has a range of complementary supporting services linked to our laboratory operations. Clients’ biomarker programmes can benefit from our specialist expertise across a number of key areas including data sciences, regulatory affairs and overall project management of programmes from early biomarker discovery through to clinical trial assay development and commercialisation of companion diagnostics (CDx).
An overview of each key area is provided below, with links to a greater depth of information should you want to explore these supporting services further:
Data Sciences
Our Data Sciences team partner with clients throughout their biomarker programmes, fully supporting the discovery, development and delivery of biomarkers. Almac’s Data Sciences team has developed novel and proprietary software pipelines for comprehensive DNA and RNA analysis. Our highly experienced scientific experts have a substantial understanding of bioinformatics, biostatistics, data management and machine learning, software development and diagnostic product development.
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Regulatory Support
Our regulatory team has experience in working with various global regulatory agencies. We have significant expertise, built up over many years, to help pharma and biotech clients navigate the regulatory landscape in key global territories. Almac currently manage regulatory plans for companion diagnostic tests in multiple global regions including USA, Canada, Europe, Japan and China. We provide regulatory support solutions including: Global regulatory strategies for CDx development, CDx and IVD pre-submissions, IDE submissions, EU device & performance evaluation registration, Device classification assistance, Analytical and clinical protocol design, Regulatory submissions, Regulatory agency liaison, Medical device reporting and Post-market support.
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Project Management
Our experienced Project Management team work with clients throughout the lifecycle of their project to provide a comprehensive service from initial study design and planning, all the way through to the commercialisation of a diagnostic test. We recognise that each biomarker project is unique and has its own challenges. Almac establish a dedicated Project Manager as a client’s single point of contact to ensure that all key deliverables and timelines are met and that regular communication updates are provided. We foster a collaborative working partnership with our clients through transparency & flexibility to achieve shared goals. Our project managers often become a trusted & valued extension to our client’s team.
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Clinical Support
Our dedicated clinical support team is headed up by Almac’s experienced lab directors who are qualified to deliver assays internationally. The team provide medical support for the design, set up and delivery phases of clinical trials. We also offer commercialisation support activities for CDx Programmes including medical affairs planning for commercial launch. Almac’s Medical Team has appointed and managed several Scientific Advisory Boards with Key Opinion Leaders and have engaged with Patient Advocacy Groups and Co-Operative Groups to inform product development and meet market requirements.
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