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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Landmark Phase III Trial Shows Keytruda Significantly Improves Event-Free Survival in LA-HNSCC
April 28th 2025Interim KEYNOTE-689 trial data show that perioperative Keytruda significantly lowers the risk of disease progression or recurrence in resectable, locally advanced head and neck squamous cell carcinoma, marking the first major clinical advance for this patient population in more than two decades.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.