5 critical factors in choosing software for clinical data management
Here are some practical guidelines to selecting an EDC system. Some basic blocking and tackling. Always good. EDC not paper Electronic data capture (EDC) systems are basically the standard for clinical trial data management. To put it simply, the old-school process of using a paper case report form (CRF) and then uploading it into an […]
5 key questions for choosing clinical data management software
Pricing from the big EDC vendors is complex and confusing and the overlap between CRO clinical data management services and their EDC solutions locks you into a proprietary system of high-costs and expensive professional services. The non-transparency of the clinical data management market As the CEO of an innovative biomed or biotech company doing clinical trials, […]
3 critical success factors for patient compliance automation
Even if you are new in pharmaceutical or medical device clinical trial industry, it is more probable than not that you recognise the value of accurate and secure data capture. After all, whether Phase I or Phase IV, the essential purpose of conducting clinical studies is to collect and manage quality data at the behest […]
3 practical tips for cost-effective clinical monitoring
Originally posted by Jenya Konikov-Rozenman on May 31, 2016 in Clinical Trial Monitoring Can you use technology to reduce the costs of your clinical trial and shorten your time from study data lock to regulatory submission? Jenya talks about how medtech developers can save money and reduce their time to market. If you are a medtech company […]
WannaCrypt attacks
For your IMMEDIATE notice: If you run medical device Windows management consoles, run Windows Update and update your machine NOW. This is my professional advice considering the new ransomware worm out there attacking machines MS17-010 has been out more than a month, but we have to assume that that the majority of Windows-based medical devices […]
What is more important – patient safety or hospital IT?
What is more important – patient safety or the health of the enterprise hospital Windows network? What is more important – writing secure code or installing an anti-virus? A threat analysis was performed on a medical device used in intensive care units. The threat analysis used the PTA (Practical threat analysis) methodology. Our analysis considered […]
Why HIPAA Policies and Procedures are not copy and paste
Compliance from Dr. Google is a very bad idea. Searching for HIPAA Security Rule compliance yields about 1.8Million hits on Google. Some of the information is outdated and does not relate to the Final Rule and a good deal of other information is sponsored by service providers and technology companies selling silver bullets for HIPAA compliance. The […]
Encryption and medical device cyber security
I have written pieces here, here, here and here on why encryption should be a required security countermeasure for network medical devices – but curiously, the HIPAA Security rule – Appendix A does not specifically require encryption. The final FDA guidance on cyber security for medical devices takes a similar position that we’ve adopted over the years – […]
Procedures are not a substitute for ethical behavior
Are procedures a substitute for responsible and ethical behavior? The behavior of former secretary of State (and Presidential race loser) Hilary Clinton is an important example of how feeling entitled is not the exclusive domain of under 20-somethings. When we do a threat analysis of medical devices, we try to look beyond the technical security […]
The chasm between FDA regulatory and cyber security
When a Risk Analysis is not a Risk analysis Superficially at least, there is not a lot of difference between a threat analysis that is part of a software/hardware security assessment and a risk analysis (or hazard analysis) that is performed by a medical device company as part of their submission to the FDA. […]
