London, UK, 25 March, 2015: MyMeds&Me, a leading SaaS provider of web-based adverse event and product quality capture solutions for life sciences, today announced their collaboration with Oracle Health Sciences to provide the Reportum® solution to Oracle Argus safety customers.
This collaboration allows access to the innovative Reportum® solution providing a standardised method of capturing complete Adverse Event data at source, from all reporter types. The Reportum® solution provides simple, web-based, user-friendly safety data capture at initial reporter interaction and supports direct reporting by consumers - streamlining what is often a paper-based activity that generates duplicate data entry processes, call centres - often dealing with high volumes of contacts with varying levels of experience and healthcare professionals.
For Oracle customers, the Oracle Argus pharmacovigilance platform will provide the hub for all safety and product quality data captured via the Reportum® solution. They will be able to review, manage, analyse and report all safety and product quality data consistently, irrespective of reporting route.
This combined solution will enable life science companies with Adverse Event obligations to: o Increase pharmacovigilance efficiency and reduce cost
o Deliver complete, cleaner data to regulators, faster
o Improve understanding of benefit risk profiles for pharmaceutical products
Dr. Andrew Rut, CEO at MyMeds&Me comments, “The recent ISMP report1 highlighted the scale of the issue of non-complete AE data submitted to the FDA. We believe the collaboration with Oracle Health Sciences delivers innovation to Oracle Argus Safety customers who will benefit from rapid access to complete and cleaner safety data, irrespective of reporter route, by implementing the Reportum® solution”.
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.