Explore variability in drug response with IMGM's Pharmacogenetics Services

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Contracting and Audit

By selecting IMGM as outsourcing partner for your clinical study, you can count on a professional business relationship. We negotiate Confidentiality Disclosure Agreements (CDAs), Non-Disclosure Agreements (NDAs), Frame Service Agreements (FSAs) and Quality Agreements with you as necessary. In addition, we are regularly audited by customers from the pharmaceutical industry and invite you dearly to get to know us in more detail as well. It's important that you can fully trust your service provider, as the accuracy and reproducibility of your data as well as their complete documentation and GC(L)P conformity are crucial to your overall project success. For more information on our Quality Management, click here.

Your benefits are:

  • Professional business relationship ensured by contracts
  • Possibility to audit IMGM
  • A reliable quality management system

Project Discussion

At the beginning, we'll make sure to understand the exact goal of the planned analysis and how it fits into the context of your clinical studies. Our discussion might address e.g. whether the pharmacogenetic data are to be used as inclusion/exclusion criteria or for a post-hoc analysis. Depending on your scientific question, we will then use our long-standing knowledge in pharmacogenetic analysis and biomarker discovery as well as a broad range of available technologies to advise you on the best combination of methods to use. Agreements on turn- around times (TAT), interim report(s) and data format/transfer specifications (DFS/DTS) will also take place at this point. You will then receive a project-specific quotation including all suitable options and further details. We also recommend signing a Quality Agreement with us, which covers all important aspects of GC(L)P.

Your benefits are: 

  • Free of charge and in-depth consulting
  • Flexibility due to a broad spectrum of up-to-date technologies
  • Detailed and comprehensive quotations including background information

Start of the Project

After placing your pharmacogenetic order with IMGM, a personal project manager is assigned to take care of your project from start to finish. He or she will be your direct contact person and keep you up to date regularly. Once your samples have arrived at IMGM, they will be quality checked and stored for later use.

Analytical Plan

IMGM's analytical plans are very detailed and offer you a complete and comprehensive overview of your project. At the same time, they are QA-reviewed and ensure compliance with GC(L)P guidelines and regulations. The analytical plan contains contact details of all relevant people, includes references to the clinical trial protocol and gives detailed information on the scope and methodology of the study (objective, materials & methods, reporting). Furthermore, details about retention of documentation, quality assurance and relevant SOPs are listed. 

Your benefits are:

  • Personal project manager
  • Detailed overview on responsibilities, methods, reporting and documentation
  • Compliance with GCP guidelines and regulations

Analysis and Bioinformatics

At IMGM, you can order customized or standard solutions. Our profound knowledge of biomarker discovery enables us to offer not only pharmacogenetic testing of standard ADME genes, like CYPs, UGTs or NATs. Additionally, we offer large scale analyses, like microarray solutions including predesigned microarrays (e.g. DMET Plus) or custom designs (e.g. Infinium HD technology). Further, we have the expertise to design and analyze NGS and companion diagnostic panels.

Based on our long lasting expertise, we set up bioinformatics pipelines and do extensive literature research to fulfill customer’s demands.

Your benefits are:

  • Genotyping of single markers as well as broad screening approaches
  • Custom assay design and validation
  • Comprehensive bioinformatics

Analytical Report and Data Transmission

Data and results will be reported within the Analytical Report in accordance with your data format specifications (DFS) to make integration into your databases as easy as possible. Data transmission via our https server ensures that your data remains secure and protected from unauthorized access.

Your benefits are:

  • Detailed reports including informative graphs and tables
  • Adjustable data format specifications
  • Secure data delivery