• 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

  • Site Solutions Summit 2012: New Trade Association Grabs Spotlight

    Oct 30 | eCliniqua | The recently held annual Site Solutions Summit* was a high energy gathering of 500 clinical trial professionals culminating with a big announcement—the formation of the Society for Clinical Research Sites (SCRS). This new trade association is intended to provide a much-needed collective voice and a community for global investigative sites, which are anxious for a place at the table as the clinical trials industry works to improve operational efficiency.

    Oct 30, 2012

  • Four Ways an Integrated EDC/EHR Platform Can Boost Your R&D Efforts

    Oct 29 | eClin | Vendor Contributed Comment | 2012 has been a bumpy ride for pharmaceutical firms, exacerbated by a significant loss of revenue related to drug patent expirations. It’s been estimated that drugs scheduled to go off patent this year represent over $30 billion in sales. A wealth of new tools and technological advancements may be the answer for how researchers can discover new, life-saving therapies more quickly while simultaneously cutting costs. One development that is generating a lot of industry buzz is the integration of electronic data capture (EDC) platforms, traditionally used to manage clinical trials, with those used within the health care industry to create and maintain electronic health records (EHR).   

    Oct 26, 2012

  • MMG, Remedy Health Media Partner on Patient Recruitment

    Oct 17 | News Brief | MMG, a clinical trial patient recruitment firm, and Remedy Health Media are partnering to deliver unique access to a larger pool of qualified potential clinical trial participants.

    Oct 17, 2012

  • BioClinica Expands Imaging Services

    Oct 16 | News Brief |  BioClinica has announced the immediate availability of new and expanded imaging services critical for clinical trials in the area of osteoarthritis.

    Oct 16, 2012

  • Clinical Trials Influencing Investors

    Oct 16 | Seeking Alpha | Do clinical trial results sway biotech investors? Investors may be able to determine FDA approvals from trials, but then again they may not.

    Oct 16, 2012

  • Nextrials, InClin Sign Partnership

    Oct 8 | News Brief | Nextrials and InClin sign partnership to link Prism to CRO services.

    Oct 15, 2012

  • Sanofi, Massachusetts General Hospital, Sign Trans Med Agreement

    Oct 9, 2012 | News Brief | Sanofi has announced a two-year agreement with Massachusetts General Hospital (MGH) aimed at furthering translational medicine research to develop new treatments for various types of hematological malignancies and solid tumors.

    Oct 15, 2012

  • DATATRAK Signs Imaging CRO Partner

    Oct 9 | News Brief |  DATATRAK International has announced that ABX-CRO, a company providing global molecular and advanced imaging services for oncology and neuroscience to the pharmaceutical and biotechnology industries, is its first imaging partner.

    Oct 15, 2012