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Clinical trial support
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Clinical trial support
Prior to the initiation of a clinical trial with cell and gene therapy products a lot of questions relating to the production of the trial medication need to be answered. These include:
- Is your starting material suitable for GMP production?
- Is GMP material needed for preclinical studies?
- Is the process of production GMP compliant or does an optimized process need to be developed?
- How long will it take from start of GMP production to the release of the product?
- When should GMP production start?
- Which documentation has to be established prior to and concomitant with GMP production?
We can help you to answer these questions.
Production of clinical trial medication
See our pages on GMP production of vectors, gene-modified cells and cellular therapeutics.
Molecular patient monitoring
Gene therapy trials allow/require a larger number and wider range of assays on patient samples than traditional drugs. We offer:
- Safety testing on samples from clinical trial subjects (e.g. test for replication competent retroviruses)
- Efficiency testing on samples from clinical trial subjects (e.g. quantification of gene-modified cells)
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