It seems like you no longer have to look for drug safety gossip…it finds you! Any website you browse, newspaper you open, or evening news you tune into, there is talk about Avandia, diabetes safety, and cardiovascular risk. In a previous blog – Battle of the Brains - Orlando – we asked the question of what measures and steps the FDA would take to prevent this in other therapeutic areas. Well the increased reports of MI due to glucose lowering Avandia has finally found a mate in an anti-obesity drug, Qnexa.
Hitting the press yesterday, the FDA said “reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others.” Ring the bells; we’ve got a match.
But besides the high pressures these pharmaceutical companies are facing by the regs, feds, and industry, what can be learned? Medpace knows adjudication is the answer. Better articulation of final reports, real time platforms for adjudicators, and easily customized, study specific portals allow the adjudication committee to reach a unanimous diagnosis for each case identified and presented.
Medpace’s ClinTrak® Adjudication Module is a component of our proprietary project management software program housing EDC and Adjudication capabilities. To learn more about Medpace, ClinTrak®, or our Adjudication excellence, check out http://bit.ly/aWVjkL.
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