• BioClinica Plans Clinical Supply Chain Management Study

    Feb 18 | eCliniqua | BioClinica has partnered with Paragon Solutions to plan a study to assess current industry business challenges and trends facing clinical supply chain management, including: study-drug forecasting, study design, and cost reduction opportunities.

    Feb 17, 2011

  • Automated Processes to Support Compliance

    Feb 17 | News Brief | Pegasystems has announced its new Life Sciences Industry Foundation, to help improve compliance efficiency through improved collaboration and automation.

    Feb 17, 2011

  • A Case of Delayed Gratification

    Feb 10 | eCliniqua | BioClinica CEO Mark Weinstein’s career started out at Andersen Consulting before moving to Thomson Healthcare in the early 1990s. He joined Bio-Imaging Technologies in 1997, later rebranding the firm as BioClinica as the company grew and diversified. Weinstein spoke to Bio•IT World chief editor Kevin Davies about his company’s rapid growth in particular and the trends for the eClinical space.

    Jan 26, 2011

  • Bridging Research and Clinical Bioinformatics

    Feb 9 | eCliniqua | It will soon be cheaper to sequence a patient’s entire genome and use software filters to implement genetic testing than to conduct multiple separate tests for specific genes. Notwithstanding unresolved regulatory, legal, reimbursement, physician training, and privacy issues related to whole-genome testing, there remain big bioinformatics issues as well.

    Jan 26, 2011

  • Embracing Adaptive Designs at Merck

    Feb 8 | eCliniqua | Since his days as a senior biostatistician at Wyeth, Jerald Schindler has been a vigorous proponent of adaptive trial designs as a means to monitor the effectiveness and improve the efficiency of clinical trials. After a stint on the vendor side at Cytel, Schindler joined Merck in 2007 as VP late-stage clinical development statistics.

    Jan 26, 2011

  • Trial Planning Software Gets Update

    Feb 7 | eCliniqua Products | ClearTrial has released version 4 of its “clinical trial operations” software, an update the company calls a “major upgrade” to the software-as-a-service offering.

    Jan 27, 2011

  • Survey Verifies Significant Benefits of eTMF

    Feb 7 | eCliniqua | In June of 2010, an industry coalition under the auspices of the Drug Information Association (DIA) published version 1.0 of the Trial Master File Reference Model. The trial master file (TMF) contains those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. All sponsors and investigators, as well as those conducting trials in academic research, are required to maintain documentation for each clinical trial. Regulatory guidance, such as ICH E6 section 8, addresses only a sub-set of TMF documents. As a result, until version 1.0 of the Trial Master File Reference Model (TMF RM) was released, no comprehensive common model existed for the TMF.

    Jan 26, 2011

  • The Value of Smart Integration

    Feb 4 | eCliniqua | Aris Global, which has been in existence for about 20 years, is best known for its software solutions for safety and pharmacovigilance. Two years ago, the company tapped Sylva Collins to expand its software solutions and services to other areas of eClinical research. Collins has a wealth of eClinical expertise—about a decade ago she introduced electronic data capture (EDC) to Novartis and later had a stint at Kendle, a contract research organization.

    Jan 26, 2011

  • Partnering with Pharma: A New CRO Approach

    Feb 2 | eCliniqua | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”

    Jan 26, 2011

  • The New Normal for Clinical Trials

    Jan 31 | eCliniqua | An assortment of emerging clinical trial technologies over the past decade are providing creative ways for pharmaceutical companies and clinical research organizations (CROs) to boost the quality, pace, and efficiency of their drug development programs. The promise is sporadically realized by companies that selectively and appropriately apply these tools and use timely and visible performance metrics as the basis for relationship-building with clinical investigators. Working recipes are not often diligently followed, however. Thus clinical trials performance, in the main, remains dreadful.

    Jan 26, 2011

  • Government to Fund Drug Research

    Jan 25 | New York Times | The government's new drug development center, the National Center for Advancing Translational Sciences, isn't intended to be comptetitive with the private sector, says NIH director Francis Collins. The center is slated to open in October and will be one of the 27 centers and institutes under the National Institutes of Health.

    Jan 24, 2011

  • Cetero Hires Former Schering-Plough Bioanalytical Director

    Jan 20 | News Brief | Cetero Research, an early-stage contract research organization, has appointed Roger Hayes as president, bioanalytical operations. For the past 10 years, Hayes has served as director of bioanalytical at Schering-Plough Research Institute. 

    Jan 19, 2011

  • Past Clinical Trials Not Cited

    Jan 18 | New York Times |  Johns Hopkins researchers have found that published papers on clinical trials rarely cite previous works on the same topic.

    Jan 18, 2011

  • Partnering with Pharma: A New CRO Approach

    Jan 18 | eCliniqua | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”

    Jan 18, 2011

  • Merck, Parexel Sign Generics Deal

    Jan 13 | Boston Business Journal | Parexel and Merck have signed a deal to help the pharma develop generic versions of biologics.

    Jan 12, 2011

  • Portal Partnering: Connecting Pharma and CROs

    Jan 10 | Comment |  The contract research market grew 13% in 2009, reaching $23.5 billion, according to the Contract Research Annual Review 2010 report. But as these partnerships with contract research organizations (CRO) become more common, it will become essential to establish collaborative communications with their partners and leverage workflows to help encourage communication and improve the efficiency of the working relationship. A partner portal, connecting the sponsor with the CRO, is an effective platform to achieve these goals.

    Jan 10, 2011

  • First Candidate from Nanoengineering Platform

    Jan 10 | News Brief | BIND Biosciences has started the Phase 1 trial for the first candidate from its broad proprietary Medicinal Nanoengineering platform.

    Jan 10, 2011

  • Drug Approvals Down in 2010

    Jan 5 | Wall Street Journal | The FDA approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

    Jan 4, 2011

  • DIA Launches Regulator Affairs Certificate Program

    Jan 5 | News Brief | DIA has announced a regulatory affairs certificate program to provide comprehensive training on current regulations and their practical application to the development and commercialization of pharmaceutical, biotechnology, medical device, and related health care products.

    Jan 4, 2011

  • EMRs Have Mixed Effects on Productivity

    Dec 27 | UC Davis | A UC Davis study has found that electronic medical records may not be the "silver bullet" of health care reform that some hoped. The study measured the impact of electronic medical record-keeping on doctors' productivity.

    Dec 20, 2010