Webinar: eCOA Best Practices: A Framework for BYOD Success

MALVERN, P.A. – May 16, 2019 – Bring-your-own-device (BYOD) approaches for electronic clinical outcome assessment (eCOA) implementation generates considerable industry discussion and debate. BYOD models offer significant convenience to patients but uncertainty about logistics, technical performance, end user support and regulatory acceptance still guides industry decision-making. Join Donna Mongiello, Vice President of Strategic Solutions at…

Practical Considerations for Patient-Focused Data Collection in Oncology Trials

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…

SCOPE 2019 Summary – Beyond the Pilot, Moving Towards Implementation

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…

Demystifying IRT Terminology

Bryan Clayton, Vice President, Strategic Solutions   On October 25, I presented a webinar to discuss IRT terminology, SDLC methodologies and how different approaches can save time, risk and cost. Though they may seem similar, customized and configurable systems are quite different. Each approach presents its own set of challenges.  Before I started my main…

CBI’s Annual eCOA Conference Highlights

Donna M. Mongiello, RN, BSN, Vice President, Strategic Solutions CBI’s annual eCOA event took place on Oct 23 in Philadelphia. As co-chair with Ken Grice of Bayer, we presided over a range of eCOA subject matter experts who presented a diverse mix of topics covering technology, operations, translations, wearables, BYOD, quality management and regulatory considerations.…

CBI’s Annual IRT Conference Highlights

Bryan Clayton, Vice President, Strategic Solutions CBI’s Annual IRT Conference opened to a packed house on Monday, Oct 22. Conference Chairman Craig Mooney kicked off the two-day event with a summary of emerging trends, as well as calls to action for sponsors and vendors. Hot topics and themes at this year’s conference included: New approaches…

Industry Insider Interview Series: Dan Hilby, Principal Technical Services Manager

Dan Hilby, Principal Technical Services Manager, PRA Health Sciences This post is the fourth in our larger series, Industry Insider Interviews. Read our previous posts, featuring Ed Potero of Biogen, Dagmara Kulis of EORTC and Alexandra Crane and Jessica Millman of TransPerfect   Oversight of Takeda Pharmaceuticals IRT YPrime: Tell us about your background in IRT DH:…

YPrime Announces Executive Appointments

MALVERN, P.A. – August 21, 2018 – YPrime announces two key appointments to its executive management team. These appointments bring industry-leading expertise to help YPrime navigate burgeoning demand for eClinical solutions and a rapidly changing regulatory environment. Mark Maietta will serve as President, in addition to his current role as Chief Commercial Officer. Steve Begley…