TrialScope announced the latest release of its PharmaCM platform (v.2.2)
TrialScope, a provider of clinical trial transparency and compliance solutions, announced the latest release of its PharmaCM platform (v.2.2) that automates and manages clinical trial results reporting via the European Medicines Agency’s European Clinical Trials Database (EudraCT).
The new EudraCT results reporting functionality is a first-to-market solution that enables clinical trial sponsors to convert results data formatted for US National Institutes of Health registry (www.clinicaltrials.gov) to the format required for EudraCT. This approach reduces the data entry effort for EudraCT results by up to 85% and applies preconfigured workflows and audit trails to the complex process of disclosing clinical trial results to the European registry. The requirement to report trial summary results became mandatory for sponsors as of July 21, 2014.
Read the full release here.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
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.