Treating EDC Induced Dissociative Panic Disorder

There is considerable online discussion about real-world data in clinical trials, virtual trials, digital trials, medical IoT, wearables, AI, machine learning for finding best candidates for treatment and digital therapeutics.   From the EDC vendors’ web sites – everything is perfect in a perfect world. Medidata Rave – for example: Run Your Entire Study On A Unified, […]

Putting lipstick on the pig of electronic CRF?

Good online systems do not use paper paradigms. In this post – I will try and entertain you with historical perspective and quantitative tools for choosing an EDC system for your medical device study. Decades of common wisdom in clinical trials still hold to a paper-based data processing model. One of the popular EDC systems […]

Israel Biomed 2019-the high-social, low stress STEM conference

Impressions from Biomed 2019 in Tel Aviv This week was the annual 3 day Biomed/MIXiii (I have no idea what MIXiii means btw) conference in Tel Aviv.  The organizers also billed it as the “18th National Life Science and Technology Week” (which I also do not know what that means). This was a particular difficult […]

Patient compliance – the billion dollar question

The high failure rate of drug trials The high failure rate of drugs in clinical trials, especially in the later stages of development, is a significant contributor to the costs and time associated with bringing new molecular entities to market. These costs, estimated to be in excess of $1.5 billion when capitalized over the ten […]

Teetering on the precipice of medical device/digital health clinical trials

Danny teeters on the edge of the precipice of privacy and security. Step on the brakes not on the gas and don’t look down. Take a 500m leap of faith into the chasm of medical device clinical trials. Validate digital therapeutics. Venture into uncharted territory of medical cannabis trials. At some stage in my “let’s […]

Why EDC is essential for any medical device clinical trial

This is a post David wrote a while back and it still seems relevant.  If you would have asked me 2 years ago – I would have told you that in 2018, no one would be doing paper medical device clinical trials the same way that no one does paper accounting.   I would have thought […]

Important EDC features for medical device clinical trials

Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware. Electronic data capture software (EDC software) systems have demonstrated that […]

Why healthcare IoT devices need data monitoring

Use of healthcare IoT devices for sensing patient vital signs  enables fast and cost-effective remote monitoring of patient safety and data quality – however the challenges start after collecting the data. Healthcare IoT for sensing patient state is not a panacea. Monitoring of data you collect in your clinical trial using healthcare IoT requires up-front […]

The 2 most common mistakes in Clinical Research Data Management

Another survey piece that David wrote about common mistakes in clinical data management and some basic controls to stay from the common issues. Use automated monitoring to empower people We are all human. As much as we would like to rely on technology to automate every sector of clinical trial research, we still need the […]

The best alternative to paper in medical device clinical trials

There is an urban legend that paper is cheaper than EDC $1000/subject for paper-based data management (the going rate in Israel)  is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO. The TCO of doing a clinical trial for an […]