June 26, 2019dia

One Database

Merge’s Unified Trial System

July 12, 2012

As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time. Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring reports? Separate database. Drug safety information? Separate database. The multiple-database approach gave birth to a problem. Suppose a clinical trial manager asked, Is there something that our clinical sites don’t understand about our adverse events? No Answers Such an ostensibly simple question might require heretofore isolated systems to communicate. Which is easier said than done. That apparently simple question could flummox the IT department of a clinical development organization with more revenue than a moderately large Latin American country. Indeed, when the companies paying for clinical trials asked for small databases to communicate, formerly…more...

Temple, O'Neill At DIA

Global Doubts

July 12, 2010

As the industry scrambles to find the patients it needs outside the U.S., the organizers of the 2010 annual Drug Information Association (DIA) in Washington, D.C. decided to assemble the sort…more...

2010 Keynote Address

Hamburg At DIA Annual

June 17, 2010

The 2010 annual Drug Information Association meeting began with a new dual-element musical interlude. The first composition amounted to elevator music, by an anonymous band inspired by the hard rock of…more...

Searching For Sticky Notes

Auditing Technology At Trial Sites

August 10, 2007

We’re digesting our DIA notes from this year’s annual meeting in Atlanta. Still. One of memorable presentations was from Susan Flynn, chief quality officer at Clinsys Clinical Research, a contract research…more...

Who Should Not Recruit?

Clarification: Pfizer Site Strategy

July 11, 2007

After a complaint from Pfizer, we’ve updated a recent story about DIA. There’s a link to our first story at the bottom of this article. It’s clear ClinPage accurately quoted Andy Lee, Pfizer’s vice president of clinical study and data management. He and the company do have concerns about sites working for too many sponsors, using too…more...

BBK’s Freebie Generates Buzz

DIA Swag of Choice

June 25, 2007

“A major manufacturer is interested in funding your Phase II study. Collect $150.” “Investors are impressed with your Phase I results. Collect $50.” “Discover new reptile saliva extract that offers a potential cancer treatment. Collect $150.” It’s all part of “Monopoly: The Clinical Research and Development Edition,” a creative (and bulky) bit of swag that had folks…more...

Siege Mentality? Not Helpful.

Advice for A Media Crisis

November 22, 2006

There’s a new article in the Outsourcing-Pharma website that is pretty interesting. Most organizations in the industry are not ready for a full-blown media circus, the publication says. The story extensively quotes a public relations professional who advises anyone listening ... not to use a public relations professional. Aafke Huininga of Burson-Marsteller was a speaker at the…more...

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