• After the Trial

    In the Pipeline | Why post-trial data analysis is so important: Derek Lowe looks at the case study of one company that rushed their positive Phase III trial results.

    Mar 21, 2013

  • Role of the Caregiver in Clinical Trials

    Huffington Post | The clinical trial experience affects a wide range of stakeholders, including patients' caregivers.

    Mar 15, 2013

  • ArisGlobal Launches Clinical Trial Supply Management System

    eCliniqua Product Brief | ArisGlobal has launched agSupply, an integrated IWRS (Interactive Web Response System) and logistics management system that automates the tracking of clinical trial supplies throughout the supply chain.

    Mar 14, 2013

  • Site Accreditation Standards Initiative Names Co-Chairs

    eCliniqua | Alliance for Clinical Research Excellence and Safety (ACRES) has named co-chairs for its Site Accreditation Standards Initiative (SASI). Inaugurated in December of 2012, SASI brings together prominent representatives from the multi-sector biomedical research community to promote formal standards for accreditation of clinical research sites worldwide. Linda Meyerson and Tracy Blumenfeld who will serve as Co-Chairs of the SASI Steering Committee.

    Mar 13, 2013

  • Internet Searches Reveal Adverse Drug Interactions

    New York Times | Using Google, Yahoo, and Microsoft seach histories, researchers have discovered prescription drug side effects before FDA.

    Mar 8, 2013

  • Video: Ben Goldacre Talks About Pharma's Influence on Health Care

    C-SPAN | Ben Goldacre talks about his book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. He discusses the influence of the pharmaceutical industry on the global health care system and argues that pharmaceutical companies hide negative studies and use questionable testing and intensive lobbying to get what they want, regardless of whether the drugs they produce are good for patients.

    Mar 6, 2013

  • GNS Healthcare to Mine Data in MS Drug Development Alliance

    News Brief |  GNS Healthcare has joined in the formation of Orion Bionetworks, a new alliance to accelerate the drug development process for a wide variety of diseases, beginning with multiple sclerosis (MS). Using patient data from alliance members Accelerated Cure Project for Multiple Sclerosis, the Institute for Neurosciences at Brigham and Women’s Hospital, and PatientsLikeMe, GNS will build powerful, predictive, computational models to yield new information about the disease.

    Mar 4, 2013

  • Phase 3 Trials and FDA on the Chopping Block

    eClin Roundup | Federal cost cutting measures should look no farther than the FDA, argues an op ed in Bloomberg. First on the chopping block: Phase 3 clinical trials. But would that actually work?

    Mar 4, 2013

  • PatientsLikeMe to Launch 'Patient-Centered Outcomes' Platform

    Bio-IT World | Thanks to a $1.9 million grant from the Robert Wood Johnson Foundation, PatientsLikeMe will lead development of truly “patient-centered” health outcome measures via the world’s first open-participation research platform. Never before have crowdsourcing approaches to authoring, reviewing, and validating outcome measures been attempted on a single system, says Jamie Heywood.

    Feb 25, 2013

  • For Efficient Clinical Trials, Three’s Company

    eCliniqua | Contributed Commentary | In recent years, clinical sponsors have struggled to streamline their clinical operations. Studies have grown increasingly complex with the inclusion of more procedures and eligibility criteria than ever before. The volume of data being collected for trials has increased and enrollment has become more difficult. However, sponsors’ return on investment remains unclear despite the acceptance of increased risk and efforts.

    Feb 18, 2013

  • JLL Partners Offers Buyout of BioClinica

    eCliniqua News Brief | JLL Partners, a private equity firm, announced yesterday that two of its subsidiaries have commenced a tender offer for all outstanding shares of BioClinica at a price of $7.25 per share in cash. A successful offer will result in a merger between BioClinica and BioCore Holdings, one of the subsidiaries.

    Feb 12, 2013

  • Oracle Releases Phase 1 Support in ClearTrial Plan and Source

    News Brief | Yesterday Oracle announced the first upgrade to the ClearTrial product since it acquired the company in May 2012. The newest version of Oracle Health Sciences ClearTrial Plan and Source Cloud Service will deliver enhanced planning, sourcing, and tracking capabilities to support Phase I trials and complex multi-arm studies.

    Feb 7, 2013

  • 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