Data capture by sites is activity, not achievement

Never mistake data collection activity for an achievement Recruiting and caring for patients (whether at home or on site) is a research site responsibility. Capturing pages (note the paper paradigm!) is one of the key billable metrics for a site. While data collection, detection of exceptions and action to close issues are all activities essential […]

Preventing patient data leaks

patient data leaks

6 ways to protect patient data in your eClinical and digital health applications Patient data leaks is much more than patient privacy.  Patient data leaks require a more complete approach to threat mitigation of patient data leakage, availability and data integrity attacks. Since 2019, we see rapidly increased use of decentralized clinical trials, hybrid trials, […]

How to meet the 10 top challenges in Phase 1 clinical trials

Phase 1 clinical trial challenges

Phase 1 challenges are unlike larger Phase 2, Phase 3 studies. The science is still unsure. The the clinical operations team at a startup may still be under construction. In this post, I’ll share our experiences at flaskdata.io with early stage drug and device vendors doing their first Phase 1 safety study.  You’ll see a […]

SDV sucks

Why SDV sucks

How professional services delay cures for patients. Why SDV Sucks In the early 50s of the previous century, nobody knew that 70 years later clinical trials could be run using a phone. Clinical trials that were performed 70 years ago used paper forms. By the late 70s, batch-driven data processing systems were introduced. Paper forms […]

Clinical data management, payment for outcomes

Risk assessment

Payment for outcomes using GCP metrics is a way to significantly reduce clinical operations costs and increase value-for-money from your CRO or DCT vendor. Payment for outcomes using GCP metrics shifts study costs from billable activities to measurable results. Professional service activities are hard to control. GCP metrics are hard to contest. In this post, […]

Career development for clinical data managers

case-studies-mondrian

A good clinical data manager is an essential piece of running a clinical trial.  A well-trained and responsibility clinical data manager is a an important part in study execution. A good clinical data manager will want to have a career development plan.    A clinical data manager on an individual contributor track, needs to develop […]

Are you neglecting security incident response in your DCT?

Let me ask you 3 questions.   If you answer Yes to all 3 – read this post, if not, then move on. Do you assume that your DCT  vendor has a security incident policy – based on the Web site? Are you VP R&D or CEO or regulatory and compliance officer at a drug company. […]

The last mile in clinical trials

First mover advantage for clinical trials Although the notion of same day delivery seems to be recent, in fact, competitive advantage always went to those who can move quicker. Even if they are not the first. With fast communications, there is now a relentless trend towards increasing speed. We witness this trend in almost every […]

Flask API

Open up your data. Flask API for clinical data. The most complete cloud API platform for clinical trials in the industry. Request Demo Download Fact Sheet Correct Me If I’m Wrong, 1999 Amy Sillman, The Art Institute of Chicago Interoperability is key The key to speed of implementation and data integration for your clinical trials  […]

3 ways that assure protocol compliance and data integrity in your clinical trials

In this short essay,   I’ll take a closer look at how the clinical trial supply chain is evolving.  There is now rapid change from traditional site-centric trials to patient-centric operations that assure data integrity and safety monitoring We’ll see how the pandemic, innovation in clinical operations models and consumer technology drive the change to patient-centric research. […]