Jan 30, 2013, 07:00 by Michael Croft

Boston Business Journal | PAREXEL raised its revenue and earnings expectations based on Q2 numbers that are up 27%. This is the second time the CRO has raised its 2013 numbers.

Jan 22, 2013, 09:00 by Michael Croft

Jan 22, 2013, 07:00 by Michael Croft

eCliniqua  | 1.2 billion people. Millions of treatment-naïve patients. Low cost of operations. Rising incidence of Western diseases. These compelling reasons for conducting clinical trials in India fueled an all out frenzy among pharmaceutical and biotech sponsors who flocked to India in 2005. Now, nearly a decade and thousands of trials later, a harsher reality has set in.

Jan 15, 2013, 10:00 by Michael Croft

Jan 8, 2013, 11:00 by Michael Croft

Jan 8, 2013, 08:00 by Michael Croft

News Brief | INC Research, a therapeutically-focused clinical research organization (CRO), has selected goBalto Tracker 2.0 as its global site activation solution. Tracker, a past winner of a Bio-IT World Best Practices award, is a secure, web-based platform that enables study teams to track and manage site activation activities in clinical trials.

Jan 4, 2013, 11:00 by Michael Croft

News Brief | Shield Therapeutics has selected OpenClinica Enterprise software for its clinical data management needs related to the company’s clinical trials. Shield Therapeutics develops treatments for unmet medical needs, and is currently running a Phase III program for ST10, a novel orally-delivered ferric iron-based therapy to treat iron deficiency.

Dec 28, 2012, 10:00 by Michael Croft

Dec 19, 2012, 12:00 by Michael Croft

News Brief | The University of Alabama at Birmingham is launching a study with the help of an iPad. UAB is enrolling patients via the Mytrus iPad app as part of a pilot study supported by the U.S. Department of Health & Human Services.

Dec 7, 2012, 01:00 by Michael Croft

eCliniqua | The European Medicines Agency held a workshop late last month on access to and transparency of clinical trial data. Their four-page report calls for proactive publication of clinical trial data. "It is no longer a question of if we start [sharing clinical trial data] but only of how we achieve it," said Hans-Georg Eichler, Senior Medical Officer of the European Medicines Agency.

Dec 5, 2012, 12:00 by Michael Croft

News Brief | DIA announced today that Worldwide Executive Director Paul Pomerantz will be leaving effective March 3, 2013. The DIA Board of Directors will announce plans for the executive director search in January.

Dec 3, 2012, 09:00 by Michael Croft

eCliniqua | In the not-so-distant future, the pharmaceutical industry will need to move away from serendipity and its “blockbuster” drug development approach to become a service-based business specializing in patient-specific therapeutics delivering desired outcomes at the desired price. Clinical trials, of necessity, will be re-engineered to reflect real-world circumstances and turn adaptive study programs into a competitive advantage. Practicing clinicians will be dissuaded from using high-cost medicines and more actively participate in modeling and simulation exercises to help get better products to patients sooner.

Nov 29, 2012, 10:00 by Michael Croft

News Brief | ICON was named clinical research team of the year at the annual Scrip Awards. ICON won the award for an extremely quick start-up of a large Phase III clinical trial for a promising gynaecological compound in a selective population.

Nov 21, 2012, 11:00 by Michael Croft

Drugs.com | Drugs.com released Q3 sales numbers for drug sales in the US today. Proton-pump inhibitors, antipsychotics and statins remain in the top-selling therapeutic categories, while some top sellers fall due to patent loss.

Nov 21, 2012, 11:00 by Michael Croft

Bio-IT World | Adaptive clinical trials might be globally embraced if the current preoccupation with fixed trial designs was viewed as an “engineering problem” requiring a lot of talk and teamwork between adaptive design experts, said Michael Krams, MD, vice president & head of the neurology franchise at Johnson & Johnson (J&J).

Nov 15, 2012, 08:00 by Michael Croft

eCliniqua | As part of the newly-launched TransCelerate BioPharma, Janssen Research & Development has established a global cross-pharma Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly and Company are the first two companies to join Janssen in this effort.

Nov 8, 2012, 10:00 by Michael Croft

News Brief | The parent company for Clinical Research Advantage has acquired Radiant Research. By combining these two site management organizations, the group now has 57 sites with more than 550 research professionals and an aggressive plan for growth.

Nov 6, 2012, 12:00 by Michael Croft

Nov 6 | Pharmalot | Unnecessary trial endpoints are a waste of clinical trials budget, finds a study released by the Tufts Center for the Study of Drug Development.

Nov 2, 2012, 12:00 by Michael Croft

Macleans | Canada lags behind in clinical trials transparency, but Health Canada has plans for an online trial listing, similar to the US ClinicalTrials.gov.

Oct 30, 2012, 07:00 by Michael Croft