Lead CRA Q&A: Investigative Site Recruitment Plan

Have patients lining up to be in your trials

Mumbabe said… I am a CRA stationed in the Netherlands. I have done a lot of Pre study site visits and I was wondering how do you ask potential investigators about the number of patients they are able to recruit? Which open ended phrases do you use? Here in NL it is really a big…

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3.1 oz Liquids and Gels

As a frequent traveler I have often bought 2 sets of cosmetics and toiletries so I can leave one at home and keep one group packed in my travel bag.  Lately I have been downsizing my liquids and gels even further by just carrying a 2 to 3 day portion in a pill case —…

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Rental Car Battery Died

This week Hertz rented me a Nissan Maxima.  Like so many of the new rental cars, the key is just a fob and the ignition is just a push button (you hold down the brake and you push a button on the dash that says ‘start’).  When they handed me the key they asked “Do…

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Blogroll! Plus a Sampling of Podcasts

I spend a lot of time hanging around in airports, bored in different hotels, and riding in airplanes since I do travel to work.  My favorite ways to pass the time are to catch up on email, read the news, read books or wikipedia, or dart through online blogs that interest me.  When I am…

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Investigational Product Accountability

properly consent subjects before dispensing investigational new drug

Clinical trials are conducted for new investigational products and also to explore additional endpoints/indications for marketed products or combinations.  The medication dispensed in the clinical trial is governed by country/local requirements and strict regulations dictating that it must be tracked and accounted for throughout conduct of the trial.  There are also regulations regarding how the…

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Selecting Qualified Investigators

The focus of this post will be selecting adequately performing US clinical trial sites for Investigational New Drug studies.  Depending on the nature and size of your clinical trial, you may be targeting private practices, specialists, academic centers, purpose-built dedicated clinical research facilities, or a combination of any of these to find your principal investigator(s)…

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New Year, New Destinations, New Perks?

a new year of travel and perks for The Lead CRA

I’m out on my first work trip of the year performing a few Site Initiation Visits for a new drug study in Southern California.  I’ve definitely logged some serious miles flying SFO->LAX in my time monitoring but hopefully I’ll have more sites soon in some locations that are new to me (but not anywhere it…

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ICON Warning Letter from the FDA

keep the investigational medicinal product secure in a clinical trial

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials. Routine Inspections Triggered Serious Findings My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings. …

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CRA Orientation and Training

I have been a Clinical Research Associate (CRA) for three years, but I recently accepted a new CRA position and thought it would be helpful for me to explain the on-boarding process. Whether you are working for a CRO, pharma/biotech, or as a consultant, there is always new hire orientation and training to complete. The…

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Travel Safety Refresher

travel safely as a clinical research professional

A Travel Safety Refresher So I’ve blogged before about travel safety but today we are all getting a refresher as a result of my monitoring trip yesterday. I’ve easily been to Denver 20+ times in the last 2 years for business so I’m very comfortable getting around in the airport, on the highways, and to…

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