clinical data management

The 2 big data disconnects in clinical data management

Why data is important There are 2 reasons: Determining the results of your clinical trials depends on the data Governance of the clinical trial depends on the data – but not necessarily the same data. Data-driven management is an approach that values decisions based on verifiable empirical data. The data-driven approach is crucial to success of modern, …

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Connecting with serious ill children at the Jordan River Village

Working in a startup like FlaskData.io developing cloud-based clinical data management software is like a triathlon ( I did the Eilat triathlon in 2013 so I can compare). There is a long swim of developing software where you are on your own (and maybe get kicked in the head) and then the adrenaline rush of launch when …

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2 mistakes you do not want to make in your medical device clinical trial

Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children – …

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esource for people in clinical trials

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 …

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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 …

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mhealth

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 …

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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 …

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medical device clinical trials - remote monitoring

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 …

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