Resources

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 [...]

Florence Trial Site eBinder Usage Grows Over 560% in March 2017-06-11T17:36:53+00:00

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, [...]

Interview Series: Paperless Clinical Trials 2016-04-28T15:29:04+00:00

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 [...]

The Other Side of EDC and eTMF: A Webinar with SCRS 2017-06-11T17:36:53+00:00

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 [...]

Be Audit Ready Now 2017-06-11T17:36:53+00:00

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 [...]

Secure Your Records. Protect Your Research. 2017-06-11T17:36:53+00:00

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?

2016-05-09T12:40:47+00:00

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016).  Each of these pulls the tide towards further electronic management of clinical trials. With R2, [...]

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines? 2016-05-09T12:40:47+00:00

Making Risk Based Monitoring Real for the Other 50% of Sponsors

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

This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved to targeted monitoring based on [...]

Making Risk Based Monitoring Real for the Other 50% of Sponsors 2017-06-11T17:36:53+00:00

Opposing Views on FDA Complete Response Letters

2016-05-09T17:24:12+00:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved applications. [...]

Opposing Views on FDA Complete Response Letters 2016-05-09T17:24:12+00:00

Risk Based, Remote, and Centralized Monitoring in Clinical Trials

2017-10-19T08:42:35+00:00

The Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring in clinical trials? Free White Paper - How Centralized Monitoring is Impacting Clinical [...]

Risk Based, Remote, and Centralized Monitoring in Clinical Trials 2017-10-19T08:42:35+00:00

Paper Shadow Charts: The Hidden Barrier to eSource

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

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 data [...]

Paper Shadow Charts: The Hidden Barrier to eSource 2017-06-11T17:36:53+00:00