This year’s SCRS Site Solutions Summit was the biggest ever, and for good reason—sites are coming into their own in the clinical trial value chain. Not only are sites maturing their operations and sending more staff to events like SCRS to learn, but sponsors have also realized that connections with sites are more important [...]
When discussing eSource there is as much detail to explore as any other segment of clinical trial operations. But from small biotechs to top 20 pharma, the starting point for discussions is more simple: how do we define eSource? After numerous deployments of eBinders and eBinders eSource, we've come to understand that eSource is three things. First, let's [...]
PCCTC Collaborates with Florence Healthcare to Enhance Regulatory Document Management Capabilities ATLANTA, GA and NEW YORK, June 10, 2016 – Florence Healthcare, developer of the innovative trial site-focused electronic trial site and master file (eTMF) platform, eBinder Suite™, and the Prostate Cancer Clinical Trials Consortium (PCCTC), the nation’s leading multicenter clinical research organization specializing [...]
With banking, stock trading, and now health records becoming electronic, what’s stopping someone from obtaining every detail about our lives? In clinical research, keeping Protected Health Information (PHI) – patients’ personal and identifiable information — secure is the key concern. Losing this means potentially harming the patient, running afoul of laws like HIPAA, and [...]
The benefits of eSource - where trial data remains electronic from start through data lock - are well understood. They include the elimination of transcription errors (shown by Nham et al to be 10x more accurate), reduction in duplicitous effort and monitoring requirements, and easier query resolution. With clinical EHR adoption nearing 90%, digital [...]
HL7, CDA, FHIR, CDISC, CDASH. The word jumble surfaces when researchers attempt to integrate clinical data with trial data. It also illustrates a trend where technologists, not clinicians, have control of patents' information. We propose there’s another way — an approach that puts the clinician in control of data movement. First let’s look at [...]
Payers are changing how providers get paid — from fee for service to paying for performance. This transition will be at the center of healthcare change for the foreseeable future– not only for practitioners, but surprisingly, also for therapy development. First, a little background. Pay-for-performance incentivizes providers with bonus payments as well as with [...]
Pairing remote monitoring devices with event driven medicine algorithms has the potential to address home health care’s current reliability and usability limitations. Studies have shown that home devices in this setting are fit to address the needs of chronic illnesses. Why are chronic diseases fit for this purpose? The non-intensive nature of chronic disease. Chronic [...]
Today electronic health records are now entrenched in the care experience after a painful adoption cycle. In fact, the last ten years were the decade of EHR adoption, with penetration growing from 17% to nearly 80% over the period, according to the CDC. EHR Adoption Affordable Care Act mandates drove this growth more recently [...]
