Resources

Before and After the Cloud — A Day in the Life of a Research Coordinator

2017-06-11T17:36:51+00:00

Clinical research coordinators (CRCs) play a crucial role in ensuring the success of research sites. Managing a myriad of responsibilities throughout the day, the CRC is the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, the taskmaster of the research team. CRCs are charged with ensuring high [...]

Defining eSource for Clinical Trials: Three Practical Categories

2017-06-11T17:36:51+00:00

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 set [...]

Leading Prostate Cancer Research Organization Partners with Florence

2017-06-11T17:36:51+00:00

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 in [...]

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?

2016-06-23T10:57:29+00:00

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 a [...]

Florence Trial Site eBinder Usage Grows Over 560% in March

2017-06-11T17:36:53+00:00

Florence becomes industry’s fastest-growing eBinder tool with 6x usage growth in one month; welcomes major centers as customers. Association for Clinical Research Professionals (ACRP) Conference—The pharmaceutical industry spends roughly $35 billion a year on clinical drug trials to test new therapies. About a third of that amount — $10 billion — is spent on monitoring [...]

Interview Series: Paperless Clinical Trials

2016-04-28T15:29:04+00:00

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 complexities, [...]

The Other Side of EDC and eTMF: A Webinar with SCRS

2017-06-11T17:36:53+00:00

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, monitoring [...]

Be Audit Ready Now

2017-06-11T17:36:53+00:00

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 product [...]

Secure Your Records. Protect Your Research.

2017-06-11T17:36:53+00:00

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 [...]