• Icon Buys Cross Country Healthcare Clinical Trial Services

    SF Gate | Icon plans to buy the clinical trial services division of Cross Country Healthcare for $52 million in cash and another $3.75 million in potential milestone payments. Icon provides development services to drug and medical device makers.

    Feb 4, 2013

  • PAREXEL Raises Revenue Expectations

    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 30, 2013

  • Perceptive Informatics Names New President

    Sacramento Bee | Xavier Flinois has been named to succeed Steve Kent as president of Perceptive Informatics, PAREXEL's technology division.

    Jan 22, 2013

  • India’s Regulatory Uncertainties Stall Clinical Trials Industry

    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 22, 2013

  • Big Savings Expected from First-Ever Crowdsourced Trial

    eCliniqua | Newly minted software facilitating the “crowdsourcing” of clinical trials has proven its worth in a recently-approved multiple sclerosis (MS) study that will make unusually high use of both telemonitoring and the measurement of patient mobility. The protocol, as originally proposed by Transparency Life Sciences (TLS), was significantly enriched after undergoing global scrutiny by researchers and MS patients, says Marc Foster, co-founder and chief operating officer of the open innovation drug development company. In December, it became the first crowdsourced protocol to be cleared by the U.S. Food and Drug Administration (FDA). 

    Jan 15, 2013

  • Interactive Map Lets Users Explore Clinical Trial Numbers

    eCliniqua | ClinicalTrials.gov has posted an interactive map of all of the studies listed on the site worldwide. Users can see the total number of studies by region and country, and can drill down to look at individual studies listed by condition, interventions, and study status. 

    Jan 8, 2013

  • INC Reserach Chooses goBalto for Global Site Activation

    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 8, 2013

  • Shield Chooses OpenClinica Software

    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.

    Jan 4, 2013

  • 2013 - The Year of Data-Driven Decisions

    eCliniqua Guest Commentary | Clinical trials (for the most part) are run by talented study managers who rely on experience, anecdotal knowledge, and "gut" instinct to plan and execute them.  While these study managers get trials over the finish line as close as possible to plan, it’s reckless and increasingly difficult to take a cottage-industry approach to managing these multi-million dollar projects.  As trials become more complex, expand globally and extend into new markets, even the most experienced and talented study managers struggle, resulting in highly unpredictable trial costs and timelines across the portfolio.  It’s time to take a fresh approach.

    Dec 28, 2012

  • Patient Enrollment Via iPad

    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 19, 2012

  • European Medicines Agency Tackles Transparency of Clinical Trial Data

    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 7, 2012

  • DIA Worldwide Executive Director Steps Down

    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 5, 2012

  • Adaptive Study Design May Become Survival Tactic

    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.

    Dec 3, 2012

  • ICON Wins Clinical Research Team Award

    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 29, 2012

  • Drugs.com Releases Top 100 Drugs

    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

  • Krams on Popularizing the Adaptive Approach

    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 21, 2012

  • Janssen Launches Shared Investigator Database

    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 15, 2012

  • Site Management Organizations Combine

    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 8, 2012

  • Trials Collecting Unncessary Data, Wasting Money

    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 6, 2012

  • Health Canada to Launch Trial Listing

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

    Nov 2, 2012