Summary of Day 2 Part 2 #SCOPE2014

Recap of Wednesday Afternoon at SCOPE – February 5th, 2014 Thank you for reading part 2 of the day 2 summary of sessions for Summit for Clinical Operations Executives (SCOPE) conference. Previously Posted Re-caps Day 1, February 4th, 2014 Day 2, AM sessions Couldn’t make it to #SCOPE2014? Check out recap of @Amgen & Quintiles’ talk…

Continue Reading →

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…

Continue Reading →

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,…

Continue Reading →

Another ClinOps New Year

Happy ClinOps New Year! Last year I migrated over the Lead CRA blog into a new home here at ClinOps Toolkit.  I appreciate your support and for filling 2013 with such wonderful conversation.  Many of you have already subscribed for regular updates – thank you! Here is a link to the recap of one of my…

Continue Reading →

Clinical Research Careers – a November Networking Event for ClinOps Toolkit

Let the networking event begin

The ClinOps Toolkit Networking Group met again on 11/14/13 for Clinical Research Careers Last week I co-hosted the ‘Careers in Clinical Research‘ event with ClinOps Toolkit partner, Edge Alliance.  Thank you again to our sponsor and all the attendees for an evening filled with valuable clinical research career advice and great networking and conversation.  I…

Continue Reading →

Join us 11/14 in Los Gatos for ClinOps Career Chat #opscareer

I’m looking forward to the ClinOps Toolkit meetup this Thursday, November 14th. Edge Alliance is hosting the ‘Careers in Clinical Research’ for us in Los Gatos, California. Networking starts at 6 and then my buddy, Maurice Little will give a 3-part talk at 6:45 with advice for excelling in your current career, tips for those…

Continue Reading →

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…

Continue Reading →

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 →

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 →

Page 3 of 6