ACCURACY. CAPACITY. YOUR RESULTS, DELIVERED.
CLINICAL TRIAL TESTING SERVIECS
Our mission is to create clinical trials that are accurate, well recorded, and from our client’s perspective, turnkey. To that end, our testing process contains a number of steps, all designed to ensure your data is beyond reproach, including:
• Assay Validation– Before the testing process begins, we test your vector to ensure it will remain viable within the confines of the testing procedures. We use analytical and cell based methods to test for identity, purity and potency.
• Vector and Plasmid Production – Genezen works with you to produce the vector to your specifications, creating quantities sufficient for your clinical trial needs.
• Cell Banking – We store the plasmids and vectors needed for your study in our secure cell bank room with fully validated and monitored vapor phase LN2 storage.
• Shipping to test locations – If your study is being conducted in multiple locations, Genezen can ensure that the vector gets sent according to cGMP distribution standards to every location.
For more information about Genezen’s clinical trial testing services, contact us for a consultation.
• Master Service Agreements that Fast Track Your Trial – One of the most difficult parts of getting a clinical trial organized is procuring a contract with your production/testing labs. Genezen can save you time and money through out master service agreements with some of the most well-recognized and experienced production and vector testing labs in the nation.
• Documentation for Regulatory Compliance – Genezen will supply you with letters of cross-reference to our FDA drug master filer, as an automatic part of our engagement.
• HIPPA compliant data – All of the technicians working on your trial have been fully trained on HIPPA compliance procedures, so you can be assured the trial sample and data are handled appropriately.
• cGMP manufacturing processes – Because all our facilities follow cGMP processing regulations, you’ll never have to worry about your results being invalidated due to a procedural violation. We can even provide documentation of our procedures, should they be needed during the approval process.
• Reporting to keep you in the loop – We can put together a system of reporting results and status updates so your team is fully informed of your trial’s progress. We’ll provide reports in writing, and can arrange for on-site audit at any time.
• Cell and Virus Bank Characterization – During the production process we also test your cell and virus banks to make sure the production process will produce enough needed materials to ensure the smooth and accurate running of your trial’s next stages. We offer stability testing and product release testing to ensure your vector’s viability. The results of this testing, reported in certificate analysis, will get written into a vetted process that will be sufficient to take your company into a Phase III trial, upon regulatory approval.
For more information on our clinical trial support services, contact us for a free consultation.