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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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

[box style=”1″ close_btn=”true”] Last week I gave you some timesaving tips for collecting proposed revisions from multiple document reviewers. Hopefully everyone gave you a thoughtful review, used track changes, and turned in their edits on time.  Now it is time to consolidate and review every last one of those changes (even sneaky ones that can be…

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Consolidating Document Changes from Multiple Reviewers

consolidating document comments from multiple reviewers

[box style=”1″ close_btn=”true”] I set out to write a post today about tips for using Track Changes under the document review tab.  I’ll table that post for now because, honestly  the biggest timesaver on collaborative document review is to set ground rules for the review, establish the review process, and provide sufficient guidance for an adequate review cycle.…

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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…

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Want to Save Time Managing Email? Three Email Efficiency Tips

Clinops toolkit tips for email management

[box style=”1″ close_btn=”true”] When it comes to techie tips and time-savers, I’m a junkie.  Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Special thanks to Google, my colleagues, and the…

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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…

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Cheers – Launch Party a Success!

cheers San Francisco and the clinops toolkit

Dinner is served This week I held a networking event to officially launch the Clinical Operations Toolkit. I co-hosted a complimentary dinner at a restaurant in Burlingame, a lovely city in the San Francisco Bay Area peninsula.  Space was limited but the event was open to all blog subscribers, ClinOps Toolkit Facebook followers, Twitter followers,…

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A Want or a Need?

A want or a need? Just put it on the corporate American Express card

What do we spend our money on to conduct a clinical trial? [box style=”2″ close_btn=”true”] Money Matters: This week is payday!  Hope you have nice plans for Independence Day in the US, that you enjoyed Canada Day to our friends up North, and Happy Tuesday to everyone else.   Today’s topic falls under the theme…

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What is the conference call dial-in number?

What is the conference call dial-in number? Put the Dial-In Information in a Repeating ‘All-Day” Calendar Event

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie.  Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Thanks in advance to Google, my colleagues, and the exasperated…

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