Are we being compliant with the regulatory expectations regarding the monitoring of our trials?
- Written by SHAFI CONSULTANCY on 30 October 2018
The RBM (Risk Based Monitoring) approach is now widely adopted in the industry. At Shafi Consultancy we have developed a web-based application, RiskView, which streamlines all aspects of RBM as well as giving you a unique graphical oversight. We have more than 7 years of experience in providing RBM solutions to trials with up to 16,000 patients across more than 70 countries. To help summarise the regulatory guidance, here are a few papers from FDA, EMA and TransCelerate addressing Risk Based Monitoring, as well as the topic of trial quality and fraud/misconduct:
There are some great papers being presented on RBM at the PhUSE conference in Frankfurt on the 5th November. If you have time there are still afew places available.
P.S. Please also find attached a link to papers we have presented on RBM at conferences over the past few years.
Is Artificial Intelligence in programming a gimmick?
- Written by SHAFI CONSULTANCY on 30 October 2018
Programmers write programs to perform a task that has been requested, but there is minimal (if any) impact AI can have on this. Automation on the other hand, can re-produce programs for similar tasks with speed and consistency that manual programming just cannot match.
What does this mean?
As a programmer, I see automation releasing programmers from the routine programming to spend more time on new and pivotal analyses. They also have more time for complex programming, analyses and techniques to enhance the data, improvements in quality and ultimately speeding up drug delivery.
The decision on what should be programmed however is open to AI. This decision is determined by Statisticians based on the type of data, prior knowledge, aim of the study, and many other factors that can be added to the knowledge base over time.
We now auto-generate most of the reporting programs using applications like Metalytics to report trials quickly and consistently, but how long is it before AI tells us which programs to generate?
PhUSE EU CONNECT 2018
- Updated by SHAFI CONSULTANCY on 20 November 2018
A big thanks to PhUSE, all the attendees and all those involved in making it a conference to remember!
We had a great conference in Frankfurt where we saw a wide range of presentations and met lots of clients, friends and interesting people.
Our reporting application "Metalytics" and our Risk-based monitoring application "RiskView" were very well received and lots of people attended the different demonstrations.
If you would like to find out more details about these or our other services like CDISC data generation and validation then please get in touch.
Shafi Chowdhury presented:
Software Demonstration 04: "Generating Tables, Figures and Listings Without Any Programs"
at the Phuse EU Connect conference on Monday, 5th Nov, 13:30-14:00.
Are you tired of asking "What's our validation/QC status?" or "Are the programs complete?"
Metalytics not only gives you instant oversight across all studies, the auto generated analysis programs and output it produces are easy to follow and review by all programmers, statisticians and regulatory. In addition, this automation integrates well with CDISC data and can speed up the delivery of SDTM and ADaM. The end result is that programmers have more time to spend on pivotal analyses and complex programs.
For more details visit our Metalytics page.
PhUSE US CONNECT 2019
- Written by SHAFI CONSULTANCY on 20 November 2018
Meet us in Baltimore for the PhUSE US Connect conference
24th-27th February, Baltimore, USA
Shafi Chowdhury will be presenting: "How to take the Risk out of Risk Based Monitoring"
With over 7 years of experience in providing Risk based monitoring application and services to clinical trials with up to 16,000 patients from hundreds of sites across more than 70 countries, Shafi will present what programmers can expect, what they should think about, and how they can contribute to raise the quality of the data and reduce workload by helping Clinical Operations implement an effective RBM plan.
Risk-based monitoring has been an increasing part of a programmer’s role since FDA and EMA released their reflection paper and guidance on this in 2011. However, the role and requirement is very different in different organisations, and this presentation will look at what analyses are typically performed and what programmers can do to take the risk out of risk-based monitoring.
Risk is typically calculated using data from many different sources, including fraud detection, screening failure rate, CRA feedback, EDC metadata and data quality. In addition, checks on the data that change during the different phases of trials need to be programmed, maintained and submitted by programmers. All these results not only impact how much data is monitored by CRAs at the site, but also what is monitored and how often. Hence the role of programmers in risk-based monitoring is key and growing, for which we must be prepared.
Hope to see you at the presentation! Drop by our stand to find out more or just to say hello.