Ergomed has unparalleled experience in delivering cell and gene therapy trials in oncology and rare diseases.
Gene and cell therapy is most commonly deployed in oncology and rare diseases and brings with it specific regulatory requirements, submission and processes, as well as operational challenges.
Regulatory agencies require an assessment on the release of the product into the environment (deliberate release) ahead of the clinical trial applications, while the products require a highly controlled supply chain. With cell therapy, treatments are often forms of personalized medicine.
Ergomed has the experience and expertise in cell and gene therapy trials to deliver a study set up that is adaptable enough to meet the flexibility required for collecting patients’ body materials and closely oversee shipments, IMP work up and return to the patient in the shortest possible time.
Our patient toolkit and site management team come into their own with the collection of body materials from the patient for analysis at specialty laboratories, always going the extra mile to keep samples safe and ensuring patient safety is at the forefront.
For the additional regulatory processes for advanced medical therapeutic products (AMTPs) our internal processes and agile teams will set up the logistics to meet the needs for your unique trial and to support patient care.
Ergomed’s patient-centric, flexible and highly effective site management model allows our project teams to support patients and their families, the clinical site and the sponsor.