Practical approach using an RBM framework to develop site risk profiles

While centralized monitoring is starting to be adopted within the bio-pharma industry, there remain questions about whether over reliance on data driven decisions, with less attention paid to the observations of the on-site monitors, will lead to erroneous risk assessment … Read More

Reflections from SCDM India – Risk Based Monitoring moves into the mainstream

Abby Abraham, Algorics VP of Clinical Solutions, reflects on his attendance at the SCDM event in India on 11th December, 2015. I’ve been fortunate to present at a number of global events recently where Risk Based Monitoring (RBM) has been … Read More

To Targeted SDV and Beyond…

Our Chief Commercial Officer, Rob Nichols, and I just returned from the CBI RBM (risk based monitoring) conference in Philadelphia. Although we have attended a number of conferences around the world this year, this was my first RBM focused event … Read More

Focus on what really matters

With the advent of Risk Based Monitoring (RBM) technologies, lot of organizations have developed large libraries of dashboards, scorecards, algorithms, alerts and other feedback mechanisms to provide signals on the data from a clinical trial. RBM however embraces the principles … Read More

Find yourself an entrepreneur

It has been nearly two years since I left a large global corporation and struck out on my own, firstly in consulting and then on to software products and services with Algorics, Inc. So am I an entrepreneur? Yes, to … Read More

Oh no!! It’s too late!!

Audits, be it internal, external or regulatory it is always a critical time for folks involved on the defending side. The below picture represents the list of major findings found by EMA in past clinical trials, it is interesting to … Read More

The top 4 things I took away from the eClinical Forum US spring risk based monitoring panel discussion

Last month finished up with a three day intensive eClinical Forum spring meeting at Philadelphia, hosted by ICON at their North Wales office. While there were many interesting topics ranging from EDC hosting to electronic source system readiness assessment, my … Read More

The Future’s so Bright

I am right in the middle of a 3-month consulting project to review data traceability through one function in a customer’s business. It’s a complex system of business processes involving multiple stakeholder groups across EU and US; we are only … Read More

5 startups that are doing more than just raising money

Algorithm, Inc. recently marked its first year. One year in a start up, coming up to two years since I left the (relative) security of corporate employment. There are a lot of things I pay attention to these days that … Read More

Prevention is better than the cure

Recently I have had discussions with different companies about situations where a software system failed to meet requirements, in some cases with serious consequences. When talking about how to stop the issue from reoccurring it is striking how hard it … Read More