A common question many teams ask as they face the transition to digital study documents is, “What if I get audited?” Inspections evoke fear because negative audit findings significantly impact everyone. Areas of high risk include missing documents, accurate delegation of authority logs, reporting delays, and inadequate monitoring or PI oversight. Given these risks, some [...]
Research protocol complexity is increasing and trial volumes are growing. The result - sites are struggling to take on more with the same team. Physicians and research teams are overwhelmed with cumbersome documentation and oversight requirements spread out across multiple locations. Workload imbalance and audit risk anxiety has led to turnover – exacerbating the [...]
The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here. A substantial portion of the conference revolved [...]
Emerging technology company chosen as the most innovative in clinical research at Disruptive Innovations 2016. Atlanta, Ga- Florence Healthcare, a software platform company focused on improving clinical trial site and sponsor collaboration, won the 2016 DPharm Idol competition in Boston last week. Disruptive Innovations (DPharm) is an annual event that discusses solutions in clinical [...]
The transition to electronic clinical trial binders (eBinders or investigator site files) is underway across the clinical research industry. eBinders provide several advantages for your site. Well-understood benefits include: Improved compliance. Digital binders allow you to easily track and fix compliance issues so that your site is always audit-ready - no paper sticky notes [...]
What does a modern Clinical Research Coordinator do? Clinical research coordinators (CRCs) play a crucial role in ensuring the success of research sites. Managing a myriad of responsibilities throughout the day, the Clinical Research Coordinator is the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, [...]
Florence Healthcare snags cash to switch trial sites from paper to the cloud Florence Healthcare has picked up seed funding to help clinical trial sites switch from paper files to the cloud. The funding positions a team that cut its teeth at AirWatch and Microsoft ($MSFT) to build on its early successes, such as [...]
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 [...]
Shadow charts develop for various reasons in clinical research as discussed in a prior post on shadow charts. They emerge at trial sites because of disparate IT systems: for example an EHR record may be printed onto paper for editing, redacting and signing before being rescanned into a study portal. The remaining stub is [...]
The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization. Interviewer: Mike Kassin, MD, Florence Healthcare Learn more about paperless trials today. Speaker: John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center ___________ With increasing site workload and protocol [...]
EDC and eTMF applications streamline data capture for sponsors, but what is the rest of the digital story for sites? How close is the industry really to linking electronic source and moving beyond three-ring regulatory binders? Hear what lies in store for sites in 2016 and how digitization can affect investigator oversight, document processes, [...]
The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the [...]
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 [...]
