Our services are provided by a team of physicians, scientists and pharmaceutical industry professionals with an in-depth knowledge of the practicalities of clinical studies, the realities of clinical practice and the specific expertise to integrate medical imaging into clinical study programs. Our collective skills include not only trial design, regulatory (FDA and EMEA) and health economic strategies but also practical aspects such as CMC, statistical analysis and reporting.
In addition to our unique combination of medical imaging, diagnostics and drug development expertise our approach to trial design and management differentiates us from other suppliers. Our starting point for all assignments is the science, the patient and applicable clinical management practices. We design and manage trials incorporating medical imaging and biomarkers to not only demonstrate the safety, efficacy and non-inferiority of a drug but also to substantiate its medical need and superior clinical utility.
We provide and manage the full range of services required for clinical trials and to efficiently integrate medical imaging and biomarkers into drug development programmes from consultancy, study design, implementation, management, monitoring, evaluation, and statistics through to reporting. Our Project and Data Managers and statistician have the specific specialist knowledge about the practicalities and limitations of medical imaging to provide customized GCP compliant solutions. We have good relationships with the wider imaging community and selected partners work to pharmtrace SOPs.
Our structure reflects our focus on the quality, integrity and value of medical images that can be generated in clinical trials with seamless evaluation and reporting.
