After successful completion of the preclinical stages for evaluation of your fluorescent tracer and the completion of the necessary documentation, such as a complete IMPD including animal toxicity data, we will enter the clinical evaluation phase, which TRACER™ is one of the leading centers in the world. Clinical evaluation is executed in a fully certified ICHP/GCP environment.
Prior to the design and execution of the clinical phase, together with our GMP unit and QP team, we will ensure to adhere to the standards of either synthesizing your GMP tracer or releasing your tracer for clinical use. Often this includes auditing of the site of synthesis in case you opt to GMP produce the compound outside of the UMCG GMP facility. Together with our clinical Chief Scientific Officer and clinical Operational Manager, we will design the most optimal format for execution of all phases in clinical evaluation, such as phase 0 to phase III. Our multidisciplinary team consists of pharmacists, QPs, biochemists, molecular biologists, clinicians (surgical oncology, gastroenterologists, medical oncology, pathologists), trial coordinators and biostatisticians. In all phases of clinical evaluation, we provide the necessary SOPs and ex vivo evaluation tools to build up the full documentation necessary for regulatory approval according to the international guidelines for GCP and imaging trials. A range of clinical systems are present for image-guided surgery or flexible endoscopy applications, dedicated for translational intraoperative, laproscopy and flexible endoscopy optical imaging studies (i.e. SurgVision, Olympus, Mauna Kea and Novadaq), which provide the necessary stepping-stones towards clinical evaluation.