PharmaVigilant, a clinical trial technology provider, has been selected by Supernus Pharmaceuticals to support two studies focused on the development of new drugs to treat central nervous system diseases. Supernus will implement PharmaVigilant's InSpire EDC solution, I-Vault, I-Warehouse and Remote Source Document Verification (rSDV) to support the preparation, conduct and closeout of two trials that are currently in progress.
According to Paolo Baroldi, M.D., Ph.D., Chief Medical Officer at Supernus Pharmaceuticals. Inc., "We were attracted to PharmaVigilant because it offers a cost effective solution that will benefit us in terms of speed, integration and efficiency. PharmaVigilant's integration with CROs will also allow us greater flexibility and accessibility to our data, making the entire process easier to manage at every level."
PharmaVigilant's technology offers sponsors flexibility and transparency of their data. With this technology, Supernus gains control of all data and documents including source documents across continents and across clinical services providers. PharmaVigilant offers a full suite of clinical trial technology offerings including Electronic Data Capture (EDC), data warehousing, study building (I-Builder 2.0), Electronic Trial Master File System (eTMF), Remote Source Document Verification (rSDV), study administration and an automated site payment system. PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies.
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.
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.