Forging partnerships for high patient compliance
Clarifying ownership of patient compliance in medical device clinical trials requires building risk management into the operation and forging a good partnership between clinical operations, biostatistics and the clinical data management provider who can provide the technical infrastructure for calculating compliance indicators from the EDC, ePRO and connected medical devices in the study. Although this […]
Serious fun at the Jordan River Village
Working in a startup like FlaskData.io is a combination of riding a roller-coaster and doing a 100K bike ride. There are downs (losing deals) and ups (winning deals), and adrenaline rushes(releasing great software) plus you need the stamina to ride strong on the hills and fast after the crest. I am a serious amateur musician and everyday bike rider so I […]
Invisible gorillas and clinical trial monitoring
Danny Lieberman Invisible gorillas and detection of severe adverse events. This weekly episode considers human frailty and strengths. We recently performed a retrospective study of the efficacy of the FlaskData.io tools for remote study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on a […]
Airport security versus clinical trial monitoring
Airport security versus clinical trial risk management What does taking off your shoes and belt in the airport have in common with risk assessment in COVID-19 clinical trials? Today we talk about the drawbacks of traditional clinical trials risk assessment for COVID-19. The notion of fixed risks determined at the beginning of the project is […]
Privacy, Security, HIPAA and you.
Medical devices, mobile apps, Web applications – storing data in the cloud, sharing with hospitals and doctors. How do I comply with HIPAA? What applies to me – the Security Rule, the Privacy Rule or both? Consider a common use case these days – you’re a medical device vendor and your device stores health information in the cloud. […]
Why the CRO model for drug and device trials is broken and how to fix it
Who said: ‘If you are not part of the solution, you must be part of the problem’? This appears to be a misquotation of Eldridge Cleaver author of the 1968 book “Soul on Ice” and early leader of the Black Panthers. The correct (full) quote is: ‘There is no more neutrality in the world. You either […]
5 things that make mHealth apps successful
In case you were thinking about scanning this post before scooting over to sign up to get 30 days free on our new managed Cloud clinical data collection and monitoring service – I will give you the bottom line before we start. Less technology and less information and more people. Patient monitoring is successful when it […]
What makes mHealth apps flavorgasmic?
When eating food so good that you let out an involuntary moan, usually the first bite; also as an adjective – flavorgasmic. November 30, 2008 Urban Word of the Day I downloaded this unbelievable healthcare app yesterday for my iPhone that helps me monitor my father’s health remotely. I swear when I clicked the first page […]
Crossing the valley of death of clinical trial monitoring
When hype exceeds adoption As a matter of fact, hype always succeeds adoption and rightly so – because hype is a way of getting our attention and getting us to try out a new product or service. But how can we discern substance from online marketing content? As a new hire at Intel, I wrote weekly progress […]
ICH GCP and EU Regulations impact on clinical trial monitoring
October 2015: EU standards bodies are so far behind the curve that they now emphasize CSV (which been around since 1995 or so and formally documented in 2005 see Common Format and MIME Type for Comma-Separated Values (CSV) Files) as an indication of increasing computerization of studies: New emphasis on CSV expectations, as aspects of medical device […]
