Clinical Trials Articles

Standalone software supports popular content management systems

Like all technologies, the traditional Roger's curve of technology adoption applies to the electronic Common Technical Document (eCTD) in the pharmaceutical industry. The eCTD is, as of January 2008, FDA, CDER division's specified format for submitting an electronic application for new NDA, IND, ANDA, BLA, Annual Report, and DMF submissions.

A European initiative designed to increase the participation of the elderly in clinical trials is starting to gather momentum.

To discuss current issues in subject recruitment, solutions and options in these challenging times, a roundtable of recruitment and clinical research professionals was convened by Acurian, a patient recruitment solutions provider.

Current issues

In last month's editorial, I wrote: "As the lines continue to blend between what is a biotech and what is a pharma, and even what is a CRO." I was alluding to future business models and a potential for CROs to become true partners in the development of a drug through financial risk.

What's worse than spending millions of dollars on a clinical trial only to discover your findings are wrong? Learning too late that those errors could have been prevented. Health survey administration errors, data entry mistakes, and mathematical miscues are just a few of the common missteps during clinical trials that have cost companies millions and delayed the introduction of new drugs.

Melynda Geurts
People

Roy Fleischmann
• Melynda Geurts, chief operating officer of D.L. Anderson (Dallas, TX), and Roy Fleischmann, MD, medical director of Metroplex Clinical Research Center (Dallas, TX), have both been elected as the newest members of D.L. Anderson's Board of Directors.

(Manchan, Getty Images)
It would seem senseless to start the construction of a house without a blueprint, prepare an unfamiliar dinner without using a recipe or start a season aiming for a championship without a play book. Unfortunately in the biopharm industry, far too often such conventional wisdom is lost in the haste to deliver now, and the consequences can be disastrous.

1.) Health Reform Targets Cost and Coverage

2.) Transparency Shapes Pharmaceutical R&D

3.) Designing Clinical Research for Better Patient Care

Kenneth A. Getz