spacer
home > ict > spring 2008 > expect the unexpected
PUBLICATIONS
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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

spacer
Oliver Bohnsack
spacer
spacer
spacer
Manuela Lesch
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Cerevance Establishes Strategic Research Collaboration with Merck for the Discovery of Novel Targets in Alzheimer’s Disease

Boston, MA and Cambridge, UK – AUGUST 9, 2022: Cerevance, a private, clinical-stage drug discovery and development company focused on central nervous system (CNS) diseases, today announced a multi-year strategic research collaboration with Merck, known as MSD outside the United States and Canada, to identify novel targets for Alzheimer’s disease utilizing Cerevance’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform. Cerevance will concurrently out-license one discovery-stage program to Merck as part of the collaboration.
More info >>

White Papers

Quality of Steel

Natoli Engineering Company, Inc.

Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement