Donna Mongiello, RN, BSN, Vice President, Strategic Solutions 50+ years of progress? Who knew? Most of us industry insiders talk about eCOA/ePRO as a relatively recent phenomena – of the past 20 years. During the opening presentation of CBI’s annual eCOA/ePRO conference, we learned that Dr. Warner Slack, the father of what’s now known as…
Bryan Clayton, Vice President, Strategic Solutions Last week was my seventh consecutive year of attending CBI’s IRT conference. It’s great to reconnect with colleagues and see familiar faces at each event. While accustomed to hearing common themes each year, which have recently focused on data standards, inspection readiness, new technology and protocol complexity, I’m always…
The 2019 Clinical Data Interchange Standards Consortium (CDISC) Interchange took place on October 14 – 18th in sunny San Diego at the Marriott Waterfront – quite an inspiring place to discuss standards and innovation. The President and CEO of CDISC, David R. Bobbitt, reminded us that CDISC continues a journey of change that will…
Terek Peterson, Vice President, Clinical Analytics and Data Strategies What’s the Issue? Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Global regulatory agencies have clearly embraced data standards for the submission of data, laying the groundwork for expanded adoption, to data collection,…
Justin Jaeschke, Vice President, Technology Solutions Bryan Clayton, Vice President, Strategic Solutions Next generation IRT continues to evolve from work horse to racehorse – with the power to keep pace with rising clinical trial complexity and efficiency demands. Configuration, dynamic management and advanced supply management capabilities of IRT systems help clinical teams and clinical…
Celeste Elash, Director, eCOA Sciences With acceptance of personal electronic devices (e.g., smartphones and tablets) by the public, the use of computerized systems to collect clinical outcomes assessment (COA) data in clinical trials is commonplace and becoming the preferred and recommended method.1-3 The advantages of electronic data collection over paper are numerous and well documented…
Celeste Elash, Director, eCOA Sciences When people with cancer participate in clinical trials, clinicians typically assess and record the treatment side effects that patients experience. Many key endpoints in oncology trials are not patient-reported outcomes (PROs), but rather pertain to survival, which is essentially a measure of ‘treatment activity’, and do not provide information about…
Mark Maietta, President YPrime’s Expert Community is a forum for education, ideation and collaboration. Our (plus clients and partners) point of view, best practices, lessons learned, and other advice are expressed through many formats. These include webinars, white papers, ebooks, and most recently, live events. Last week, YPrime hosted its first Expert Community event at…
Mark Maietta, President YPrime’s Expert Community is a forum for education, ideation and collaboration. Our (plus clients and partners) point of view, best practices, lessons learned, and other advice are expressed through many formats. These include webinars, white papers, ebooks, and most recently, live events. Last week, YPrime hosted its first Expert Community event at…
Donna Mongiello, RN, BSN, Vice President Strategic Solutions Last week, YPrime was among nearly 2000 participants who descended upon sunny Orlando for the 10th Annual SCOPE meeting. Expert perspectives, insights gained from lessons learned and forward-looking predictions across 10 parallel tracks focused on functional areas and emerging disciplines within clinical development. The Sensors, Wearables and…
