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Clinical Trial Supply

eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 2

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  • 01 Aug

As promised in my last blog, here is the re-cap about Electronic Source Data in Clinical Investigations: Regulatory Considerations, a session presented by the FDA during the DIA annual conference.

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Being Prepared: Alerts from Clinical Supply Pro, Buz Hillman

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  • 05 May

As clinical supply managers, we are not here for the times when things are going well. We are here because change happens and things go wrong that impact the supply chain.  We need to be able to see when change is coming and manage through that change.

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Reducing Excessive Oversupply and Costs Using Supply Chain Technology

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  • 14 Feb

Automated demand forecasting tools are transforming clinical supply management. They can be used during any phase of a trial to provide laser focus on every aspect of clinical supplies. When implemented early in the design phase, they bring additional opportunities to improve clinical trial processes. This blog provides an introductory look at state-of-the art advances in clinical supply management that are helping supply managers keep pace with change.

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Where in the World Are Your Controlled Substances? Meeting the Challenge of Inventory Management

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  • 20 Jun

Controlled substances present special supply challenges when conducting clinical trials. How can anyone stay on top of it all when a study has dozens or even hundreds of sites around the globe?

Inventory monitoring and management are even more complicated for international clinical trials as regulations vary among countries. While the FDA sets limits in the U.S. according to site storage capacity, regulatory limits in Germany are set according to maximum allowable quantity.

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Clinical Trial Supply Optimization: Direct Learning from Client Users

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  • 15 May

At this year’s BioClinica User Conference, several breakout sessions will be dedicated to exploring the ins and outs of BioClinica’s Optimizer product.  So what’s unique this year?  Several of these sessions will include presentations by actual Optimizer clients/users from companies that have faced the same challenges that you do.

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Sunny Skies for Resupplies

The Forecast? Sunny Skies for Clinical Trial Resupplies!

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  • 09 May

Note: This blog is part of a series highlighting presentations at the 2013 BioClinica User Conference, a free event for BioClinica customers May 14 – 15 in Philadelphia, PA.

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Four week supply (in 3 kits) simulation shown at day 365 of clinical trial

What Clinical Operations Need to Know About Clinical Trial Supply

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  • 10 Jun
My main responsibility at BioClinica is to show prospective customers how our software can help run clinical trials. One of my favorite products to show is BioClinica Optimizer because it can save tons of money and prevent headaches in the majority of the trials being run by optimizing the clinical supply. The interesting part about this clinical trial software is that most clinical research personnel don’t even consider looking at optimizing clinical supply. This is for many varied reasons, such as...
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Clinical Supply Simulation & Optimization: ClinPage.com Article

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  • 18 Oct
Following on several speaking engagements this year, I was recently interviewed by Mark Uehling of ClinPage to discuss some current developments in the field of clinical supply simulation and optimization. Because of Mark’s propensity to research and present (sometimes dry) information in unique and interesting ways, interviews with ClinPage are always fun - and this one was no exception! We covered topics ranging from the adoption of simulation tools in large pharmaceuticals (hint: > 50%) to the wide variety of benefits that companies realize from simulation beyond just dollar savings on clinical supply.
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Technology for Clinical Trial Supply Planning

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  • 25 Jun
The 2010 Optimizer User Conference recently ended and I am happy to report a surge in discussion around technology for clinical trial supply planning. I think this speaks well to the growth of the Optimizer product and greater acceptance of the application of more sophisticated tools to the clinical supply planning process in general. There were a number of roundtable discussions and open training sessions, which were as valuable for me as I believe they were for the attendees.
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Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices