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International Clinical Trials

Expect the Unexpected

The centralised independent reviewing process improves the skills and knowledge of the reviewers – providing important benefits for the healthcare community, the pharmaceutical industry and patients, explains Oliver Bohnsack and Manuela Lesch of Perceptive Informatics, a PAREXEL International company

Advanced medical imaging technologies play a vital role in many pivotal clinical trials today, providing primary and surrogate endpoints to support the safety and efficacy of a wide variety of biopharmaceutical products. With the dramatic improvements in these technologies in recent years, clinical study sponsors increasingly rely on imaging modalities such as magnetic resonance imaging (MRI), computed tomography (CT), ultrasound, and positron emission tomography (PET) to validate novel therapies and decrease the time and cost of clinical development.

An essential adjunct to the growing importance of medical imaging technology in clinical trials is the need for independent reviews of the study images. The initial reviews of medical imaging are performed by site-based radiologists who are directly involved in the study, therefore regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) require additional reviews by independent radiologists to validate the results.


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Oliver Bohnsack is a Medical Director based in the Berlin office of Perceptive Informatics, the technology business of PAREXEL. In this role, he has led the imaging component of multiple studies, from both a medical and a scientific approach. Oliver is a Board Certified Radiologist and has broad clinical radiology experience in Germany and the US, as well as at various companies in the biopharmaceutical industry. He holds a PhD in Radiology from the University of Munich and a Masters in Business Administration in Health Care Management from the University of California, Irvine. Oliver has presented at several international conferences on the topic of medical imaging in clinical trials, and particularly regarding the utilisation of standardised review criteria.

Manuela Lesch is a Medical Research Scientist based in the Berlin office of Perceptive Informatics. Manuela develops study-specific documents and guidelines, and assists in reviewer management. She supports companies with charter development, including presenting at investigator meetings and conferences. Manuela also has expertise in overseeing imaging operations of a range of therapeutic studies, including central nervous system (CNS) studies. A Radiologic Technologist by training, Manuela has several years of experience in multiple imaging modalities, including conventional radiology, CT, MRI, nuclear medicine and radiation therapy, and has also specialised in neuroradiology imaging.

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Oliver Bohnsack
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Manuela Lesch
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