• GSK to Implement Medidata Designer

    Apr 4 | News Brief | GlaxoSmithKline has decided to implement Medidata Designer, an innovative study design optimization solution, for its Clinical Research and Development organization.

    Apr 1, 2011

  • ICON Grows AsiaPac Business

    Apr 1 | News Brief | ICON has announced more growth in Asia Pacific, opening a new office in Shanghai, China, and also relocating its Beijing operations to larger premises.

    Apr 1, 2011

  • goBalto’s Three Easy Steps to Study Startup

    Mar 30 | eCliniqua | goBalto's Tracker aims to reinvent the clinical study startup process.  

    Mar 30, 2011

  • Perceptive Releases Survey Results for Designing Clinical Products

    Mar 25 | News Brief | Perceptive Informatics has announced results of a survey conducted during its recent webinar entitled "Designing and Delivering an eClinical Product Suite." 

    Mar 25, 2011

  • Putting Medical Records Data Through its Paces

    Mar 23 | eCliniqua | The Partnership to Advance Clinical electronic Research or PACeR (www.pacerhealth.org) was created to “convene the users and the collectors of the data to understand how we can safely reuse electronic medical record data to facilitate clinical research,” explains David Krusch, chief medical information officer at the University of Rochester Medical Center and chair of the PACeR leadership committee.

    Mar 20, 2011

  • PHT Announces Browser-Based PRO

    Mar 21 | Product Brief | At the DIA EuroMeeting next week PHT will formally announce NetPRO, an online, browser-based method for patient reported outcomes (PRO) data capture that enables sponsors to access global patient populations online.

    Mar 21, 2011

  • Ethicists Seek to Improve Risk/Benefit Estimates in Translational Trials

    Mar 21 | eCliniqua | Two ethics experts posit that drug developers, research funding agencies, and would-be trial participants could all make more informed decisions about clinical drug testing if pre-clinical studies routinely controlled for bias, and if risk/benefit estimates in new drug trials tempered enthusiasm about a compound with past findings about similar interventions.

    Mar 20, 2011

  • StudyManager Evolve Deployment

    Mar 17 | News Brief | StudyManager has announced that Meagan Medical has deployed StudyManager Evolve software to manage its latest clinical study.

    Mar 10, 2011

  • CDISC Announces New Board Members

    Mar 15 | eCliniqua | The Clinical Data Interchange Standards Consortium ( CDISC) has added three  members to its Board of Directors, each for a three year term (2011-2013).  Dr. Robert DiLaura, Dr. Eliot Siegel and Dr. Kiyoteru Takenouchi were welcomed to the CDISC Board by Chair, Dr. Frank Rockhold (GSK) last Wednesday.

    Mar 10, 2011

  • Perceptive and ClinPhone Integrate Image Tracking and RTSM Technologies

    Feb 28 | News Brief | Perceptive Informatics has announced the next level of seamless integration between its Medical Imaging Tracking application and ClinPhone Randomization and Trial Supply Management (RTSM) technologies.

    Mar 10, 2011

  • Florida House Votes Down Drug Monitoring Database

    Mar 11 | eCliniqua | Florida's prescription drug monitoring database is headed for a showdown, with a State House committee voting Thursday to kill the planned program that has vigorous support from state senators. The database is meant to help curb the state's prescription drug abuse epidemic.

    Mar 10, 2011

  • New York Hospitals Choose eClinicalWorks EMR

    Mar 8 | News Brief | Continuum Health Partners, the network of five prestigious hospitals and academic medical centers in Manhattan and Brooklyn, including Beth Israel Medical Center and St. Luke’s and Roosevelt Hospitals, has chosen to use IntrinsiQ’s IntelliDose clinical oncology software with eClinicalWorks unified electronic medical record (EMR).

    Mar 8, 2011

  • 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