Preclinical & Pharmacy
Our preclinical department provides scientific consultancy for study design, coordination and conduct for proof-of-principle for radioactive and non-radioactive medicinal products and devices at any stage of development.
With our seasoned scientific, clinical, and regulatory specialists and our extensive international network of expert centres, we are able to plan and conduct even most complex clinical studies from Phase 0 microdosing to multicentre Phase 3 and investigator-initiated trials.
We support you with consultancy and clinical trials in medical devices according to current legislation, including implantable and radiolabelled devices, as well as drug-device combinations.
ABX-CRO’s experienced Medical Monitors cover all phases of clinical programs according to ICH E6, ensuring subjects safety, rights and data integrity.
We understand the importance of patient safety, and have profound knowledge of the specific safety requirements associated with the use of radionuclides and imaging technologies.
Our Sybase server-based data management system, interfaces with SAS specifically designed for the clinical research industry, in compliance with FDA regulations, and designed to ensure the highest level of security.
Our biostatisticians rely on more than 30 years of experience, and are able to provide statistical simulations and analysis plans as well as bespoke evaluations for radio-oncology and imaging studies.