MEDIAN Technologies (ALMDT), a leading services provider for image interpretation and management in oncology clinical trials, and software provider for medical imaging, announced today the signature of a landmark contract with the top pharmaceutical company SANOFI for the interpretation and end-to-end management of medical images in a phase II study on small cells lung cancer.
For the purpose of the study, imaging data will be acquired in 65 investigator sites located in 15 countries. Anticipated total enrollment is 150-200 patients.
MEDIAN’s innovative imaging data management concept as proposed to SANOFI includes the deployment of the MEDIAN LMS platform at all 65 investigator and independent review sites.
Thereby, for the first time in a clinical trial, image interpretation tools will be harmonized and standardized among all the investigator sites and the independent reviewers involved in the study. The objective is to reduce reading variability and discordance issues in image interpretation; these are known to impact negatively the quality of clinical trials outcomes, leading, in some cases regulatory agencies, to reconsider clinical trials results.
Using MEDIAN LMS, all investigator sites will benefit from a software platform dedicated to the evaluation of patient’s response to cancer therapy providing automated and semi-automated image processing capabilities in a well-standardized workflow. The sites will be able to conduct RECIST 1.1 criteria-based evaluations in accordance with the existing international recommendations. The end-to-end image management will be carried out through MEDIAN CTIS. Notably, the real-time electronic imaging data transfer from investigator sites to independent review sites will allow the independent reviews to be processed faster and with a more efficient management of queries on missing or erroneous data.
“Thanks to this first collaboration with SANOFI, we are now supporting 4 of the 10 major pharmaceutical and Biotech companies. We are eager to start this new partnership with SANOFI, it is a very important contract and an excellent illustration of the emergence of a new paradigm in terms of clinical trial image management”, says Jerome Windsor, VP Business Development at MEDIAN Technologies. ”Until now, the optimal use of images has long been restrained due to the high interpretation variability. MEDIAN‘s solutions increase significantly the accuracy of data interpretation; they also create new perspectives for pathology follow up, and this is for the benefit of the patients”.
For the record, MEDIAN Technologies is ISO 13485 certified – ISO 13485 is the internationally recognized quality standard for the medical device industry. MEDIAN LMS applications received FDA approval in 2007 and are class IIa CE marked since 2010. LMS are used by key opinion leaders in over 100 centers in Europe, the USA and, most recently, Australia and New Zeeland. CTIS includes a set of services dedicated to image management during clinical trials and is based on MEDIAN LMS technology. MEDIAN CTIS was launched during ASCO 2011.