Dassault Systemes

Everything Clinical Trials

NEXT Hackathon 2018 Recap

This year’s NEXT NYC conference at Spring Studios was a resounding success—featuring speakers from Medidata, Amazon Web Services, Google Cloud, the Biden Cancer Initiative (with former Second Lady Jill Biden herself), and much more—catering to a diverse audience of over one thousand life sciences professionals during the two-day event. Read More

Medidata acquires SHYFT: Powering the Digital Transformation for Life Sciences

Digital transformation: this is one of the hottest topics in our industry today, creating both opportunities and challenges for our customers. For pharmaceutical, biotech, and medical device companies, the promise of making data-driven, insights-led decisions in real-time means getting the right treatments to the right patients at the right time. To truly realize this potential, they need to rely on combined insights from both clinical and commercial data. Read More

Taking the Risk Out of Clinical Trial Submissions using AI

So far Edge Trial Assurance has been used in 30 trials. It has detected 50-75 data anomalies in every single trial. Read More

Five Key Data Quality Issues To De-risk Your Trial

When it comes to submitting new drug applications to FDA, it’s safe to assume that the prospect of receiving a complete response letter keeps pharma executives up at night. The risks associated with regulatory submission can have a substantial impact on a business, and approval delays due to data issues can cost a company millions. As a former FDA reviewer, I’ve seen just about everything when it comes to data quality issues that can derail drug approvals. Luckily, today these kinds of risks can be mitigated using sophisticated data analytics. Read More

One Place: Transform Precision Medicine with Medidata Clinical Cloud

Nearly 20 years ago Medidata was built around modernizing data capture and management, which ultimately became Rave. Today, we can confidently say we’re so much more than that. Read More

The Top Three Mistakes In Monitoring Workflows

Once a problem is detected, we must ensure that it is documented, along with its associated actions and resolutions. Read More

Starting a Risk Assessment? Start Early

When it comes to risk assessment, it’s critical to look beyond what a CRA does. Read More

Cross-functional Perspectives Are Crucial For Risk Assessment

Risk assessment must go beyond the concerns of operations or monitoring teams and span the entire organization – because the conversation is no longer just about monitoring. Read More

KRI Trending Graphs and Ending the Groundhog Day Loop

The famous quote “Those who fail to learn from history are doomed to repeat it” seems appropriate when describing the pharmaceutical industry, at least according to our track record over the last few decades. It often feels like Groundhog Day, and we are Bill Murray hitting the alarm clock before realizing “Oh, here we go again!” Read More