I got a job offer – two in fact!

Just Kidding – sorry, bad joke If my boss is reading this, calm down. I just wanted a catchy title for this post, I love my current job and actually like everyone I work with – don’t worry – I’m not jumping ship today. In 2007, on this day, I started The Lead CRA blog…

Continue Reading →

CDISC for Medical Device Companies: 4 Take-Away Tips

Last night I attended the 7th in a series of Silicon Valley BioTalks Events hosted by Clinovo. The panel in South San Francisco included three CDISC experts from leading pharmaceutical and medical device companies: Dan Diprimeo – BioMarin Pharmaceutical, Director of Statistical Programming Carey Smoak – Roche Molecular Diagnostics, Senior Manager of SAS Programming, CDISC Device…

Continue Reading →

Improving Communication in Clinical Trials

Heidi Thaw

A little bit of background on our guest contributor Heidi Thaw is a CRA based in Wichita, Kansas. Heidi has extensive experience in the conduct and monitoring of clinical drug trials having performed hundreds of monitoring visits for dozens of sponsors in her 15+ year career. Heidi received her Bachelor of Arts in history from…

Continue Reading →

Virtual Meetings with Your Remote CRAs

Luizinha Monteiro

Luizinha Monteiro is a Sr. Clinical Research Associate living in Oakland, California.  Luizinha has nearly 10 years experience monitoring clinical drug trials. Prior to her transition to a CRA, Luizinha worked as a clinical research study coordinator for more than 5 years. Her valuable perspective as a coordinator and broad therapeutic experience make her uniquely…

Continue Reading →

Risk-Based Monitoring Guidance

Risk-Based Monitoring Are we having a fight

Risk-Based Monitoring Guidance August 2013 The FDA recently issued risk-based monitoring guidance in August 2013.  This guidance for sponsors of investigational new drug/device trials details a risk-based monitoring approach to monitoring safety and efficacy in studies. As with all guidances, it isn’t a flat out endorsement, recommended procedure document, or enforceable requirement list; “sponsors can…

Continue Reading →

One Document, Many Revisions, Different Versions

combining tracker changes and comments

Multiple Versions, Lots of Overlap Let’s assume that you received a marked up document from a group of interested reviewers.  For example, if you had drafted an Informed Consent Template and then circulated it to your team you might have one set of comments from legal, regulatory would weigh in, maybe your medical monitor has…

Continue Reading →

Consolidating Document Changes from Multiple Reviewers

consolidating document comments from multiple reviewers

When you Send a Word Document Out for Comments and Edits to Your Group This month I’ve been doing a lot of document review.  Just to make the projects more fun, I solicited comments from multiple reviewers.  What’s fun about that?  Merging all the feedback into a final document, who doesn’t love a good puzzle?…

Continue Reading →

Digital Informed Consent

Clinops toolkit econsent for clinical trials

eConsent Webinar by Quorum I attended a webinar last month about including eConsents (for example on tablets, iphones, or other electronic devices) in the operations of your trial for consenting subjects.  It was a case study presented by Quorum Central Institutional Review Board (IRB) and an eConsent provider. Obviously, everything we are sharing with our…

Continue Reading →

Want to Save Time Managing Email? Three Email Efficiency Tips

Clinops toolkit tips for email management

“I Feel Like I Spent My Entire Day on Email” We’re all getting a lot of email, too much, right?  I have at least eight separate email accounts. I log into most of them several times a day, from various different types of devices. It is more than a little out of control. Not one…

Continue Reading →

Nail in the Tire

Just As I was Getting Started Last week when I set out for work I realized there was a nail in my car’s tire. I discovered this first thing Monday morning; what a terrible way to start the week.  My car doesn’t actually come with a spare tire so, late to work and unable to…

Continue Reading →