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
Closing the Diversity Gap in Clinical Trials
Last month Medidata celebrated Black History Month, and we took time to come together for our speaker series MediTalk to discuss how our industry can close the diversity gap in clinical trials. Read More
International Women’s Day at Medidata
Join us next week in Frankfurt to hear from Bayer Head of Data Sciences & Analytics Benedikt Egersdoerfer and others to exchange best practices in transforming clinical development. 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
The First Large-Scale Precision Medicine Trial?
The Pancreatic Cancer Action Network has launched Precision Promise, which it calls, "the first large-scale precision medicine trial that will put the patient at the center of every decision." Read More
Get The Return You Need On Your mHealth Investment
You just decided to invest a significant portion of your innovation budget to power your clinical trial with new mobile health technology. Now what? Read More
