Summit for Clinical Ops Executives (SCOPE) Day 2

Metrics and Magic Bullets Day 1 #SCOPE2014 a recap on ClinOps Toolkit – check it out and comment to let me know you stopped by Read Day 1 SCOPE recap (04-Feb-2014) — Nadia (@clinopstk) February 5, 2014 Enrollment Planning and Patient Recruitment InVentiv Health chaired the AM session in this track and set the stage…

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Day 1 of SCOPE

A ClinOps Toolkit blog report from the Summit for Clinical Operations Executives (SCOPE) conference Day One: The AM Keynotes Ken Getz of Tufts and CISCRP kicked off the day reviewing the current climate for operations of clinical trials.  He discussed challenges like the competition we face during feasibility of our potential sites, barriers to communications,…

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What was the ClinOps Toolkit Meet the Authors Event Like?

YouTube Capture Meet the Authors of ClinOps Toolkit4

Did you attend our live streaming ClinOps Toolkit Meet the Authors meetup this week? If you missed all or part of the live event this week (or once was not enough!), re-play it anytime you like here on the ClinOps Toolkit YouTube Channel (link). Thank you to the blog readers, our viewers, and the support…

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Virtual CRA Meetings: Promoting Discussion rather than Radio Silence

Be a fly on the wall during a very productive meeting

Have you ever attended a CRA call where the Lead CRA or Project Manager talks and the CRAs just listen? Following each meeting topic, there may be a general “any questions?” inserted but the question is often followed by silence. Ineffective meetings are frustrating for all parties. The Lead CRA cannot control distractions that may…

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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…

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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…

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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…

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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…

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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…

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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…

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