The 3 tenets for designing a clinical data management system

Abstract: This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t). Enjoy! The trend of DIY: good for […]

Risk based monitoring. It’s about the people.

It will come as no surprise to anyone who is actively involved in clinical trial operations that the heart of the matter in clinical trial monitoring is people. I have written here, here and here about how people are the key assets and vulnerabilities in medical device clinical trials. Understanding people and providing timely and high-quality communications rests is a key to […]

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 […]

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 […]

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, […]

ניהול אבטחת מידע בענן – על תבונה ורגישות

ניהול אבטחת מידע בענן – על תבונה ורגישות ,ממשל נתונים הוא דרישה הכרחית להגנה על נתונים כשעוברים למחשוב בענן. קביעת מדיניות ממשל נתונים היא בעלת חשיבות מיוחדת במודל העבודה של מחשוב ענן שמבוסס על אספקת שירותים בתשלום ליחידת צריכה, בניגוד למודל המסורתי של מערכות מידע המבוסס על התקנה, שילוב מערכות ותפעול מוצרים. יחד עם ההיצע […]

Moving your data to the cloud – sense and sensibility

Data governance  is a sine qua non to protect your data in the cloud. Data governance is of particular importance for the cloud service delivery model which is philosophically different from the traditional IT product delivery model. In a product delivery model, it is difficult for a corporate IT group to quantify asset value and data […]

The effectiveness of access controls

With all due respect to Varonis and access controls in general (Just the area of Sharepoint is a fertile market for data security), the problem of internally-launched attacks is that they are all done by the “right” people and / or by software agents who have the “right” access rights. There are 3 general classes […]