Clinical Trials Articles

1. EUs Pediatric Regulation Sees First Approval:

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/...

2. Making Reality of Pediatric Rhetoric

A look at the vague but time consuming requirements imposed on sites and efforts to ease the burden.
Jan 1, 2009
By: Kenneth A. Getz
Applied Clinical Trials

Kenneth A. Getz

What antitrust authorities have uncovered so far in their search for sabotage.
Jan 1, 2009
By: Peter O'Donnell
Applied Clinical Trials

Peter O'Donnell

For the past few years, the FDA has struggled with a depleted work force, obsolete information technology, and a weak science base, according to its advisory Science Board. A new administration and new FDA leadership provide an opportunity for change. This is "a watershed time" for FDA, says Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).

New Version Open Source EDC Software

Features include study monitoring and query management tools

OpenClinica 2.5 Open for Business
Akaza Research (Cambridge, MA) announced the availability of OpenClinica 2.5, its open source clinical trials software for the clinical trials industry.

Jane Barrett discusses data quality as she addresses the question raised by DIA's 2nd European Clinical Forum: Is 90% of data rubbish?
Jan 1, 2009
By: Jane Barrett
Applied Clinical Trials

Is 90% of All Data Collected Rubbish?
Is 90% of all data collected rubbish? A provocative keynote debate at the recent DIA 2nd European Clinical Forum explored this question.

Regional recruitment managers are on the rise, providing a unique approach to onsite subject enrollment.
Jan 1, 2009
By: Kerri Nelen
Applied Clinical Trials

Jeff Bagshaw, senior vice president at InClinix, has spent the past 20 years working in industry.

A look into the current state of the eCTD format as well as its future in industry from a global standpoint.
Jan 1, 2009
By: Marissa Shapiro
Applied Clinical Trials

With greater attention and acceptance of biomarker use in clinical trials, the Society of Nuclear Medicine (SNM) is hoping to capitalize on its expertise in this area through the creation of the SNM Clinical Trials Network.
Jan 1, 2009
By: Lisa Henderson
Applied Clinical Trials

SNM Keys

Arecent Frost & Sullivan report titled "Specialty Pharma and Biotechnology Drive Contract Research Organizations Growth" included many reasons the industry will grow by $14 billion over the next seven years. These included biotechnology fueling growth, along with specialty pharma and niche or startup pharmaceuticals.