IDDI Reports Successful Partnership with TiGenix for Approval of ChondroCelect®
Louvain-la-Neuve – IDDI (International Drug Development Institute), a corporation based in Belgium, reports that its collaboration with TiGenix resulted in the approval by European Medicines Agency for the Evaluation of Medicinal Products (EMEA) of ChondroCelect® for the treatment of full thickness cartilage defects in the knee. IDDI has partnered with TiGenix for their clinical development program, including a phase III clinical trial comparing ChondroCelect® to the present standard-of-care surgical intervention called micro-fracture. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine and awarded the Hughston Award, given for the most outstanding paper that appeared in the AJSM the year prior to the award.
IDDI's trial design and statitistics were instrumental in providing strong statistical results while IDDI's data management capabilities were key in accelerating the preparation and validation of efficacy and safety data for the analyses reviewed by the agency.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
