CEL-SCI Corporation (CVM) Hires Two CROs; Multikine Phase III Trial Being Expanded
On April 23, 2013, CEL-SCI Corporation announced that the company hired two clinical research organizations, Aptiv Solutions and Ergomed, to manage the Multikine phase III study. Both CROs will help CEL-SCI expand the trial by 60 to 80 clinical sites globally. Aptiv Solutions and Ergomed have replaced the CRO currently managing the study.
Under a co-development agreement, Ergomed, which will be responsible for most of the new patient enrollment, will contribute up to $10 million towards the study. Ergomed will perform clinical services in exchange for milestone and royalty payments (single digit %) up to a specified maximum amount.
To date, the phase III trial has enrolled 117 patients at 39 centers in eight countries, including three centers in Israel, and nine centers in Taiwan.
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.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
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.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
