Clinical Operations Featured Articles

  1. Study Rescue: How To Get Your Clinical Trial Back On Track 7/13/2016

    Beth Harper has devoted more than 28 years of her life to the world of clinical research, including time at a sponsor, CRO, service provider, and start-up company while also serving as an adjunct associate professor at George Washington University. She is currently president of Clinical Performance Partners, where she works with companies to optimize study feasibility and site selection and helps to improve site relationship management practices. Although her passion is to work on proactive protocol and site performance optimization strategies, she will tell you that most of her time is spent rescuing studies. In this Q&A, Harper shares her insights on the factors that will lead to a study rescue and what companies can do to prevent that situation from arising.

  2. Duke & PCORI Use EHRs To Transform Clinical Trials 7/11/2016

    PCORI (Patient-Centered Outcomes Research Institute) and the Duke Clinical Research Institute have launched the ADAPTABLE study, a patient-centric trial designed to assess the benefits and long-term effectiveness of aspirin dosing. With a budget of over $14 million, the trial will randomize and dose 20,000 patients while leveraging health systems, EHRs (electronic health records), and patients in an attempt to fundamentally transform clinical research.

  3. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016 7/8/2016

    Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.

  4. GSK's Bold Move Into Uncharted mHealth Waters 7/6/2016

    While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.

  5. TMF Survey: Major Changes To Clinical Operations 7/5/2016

    Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

  6. With Aspire, BMS Puts Focus On Clinical Sites And Patients 6/16/2016

    Patient and site relationships are a primary concern to pharma and bio companies. The desire to be a sponsor of choice to both groups, as well as CRO partners, is suddenly a hot trend in the industry. Bristol-Myers Squibb saw both of these trends coming years ago, and has been taking steps to improve those relationships.

  7. Iroko Uses Event Monitoring System To Power Phase 3 Trial Of VIVLODEX 6/13/2016

    In a recently completed Phase 3 trial, efficacy was demonstrated in patients with osteoarthritis pain who were treated with VIVLODEX, a low-dose SoluMatrix NSAID product. The Medication Event Monitoring System (MEMS) was used in the study to accurately track when patients required additional pain-relieving medication and to show that patients using VIVLODEX required less rescue pain medication.

  8. Genome Sequencing - The Key To The Cancer Moonshot? 6/10/2016

    Though the announcement may seem recent, it was actually in October of last year when Vice President Biden boldly announced the “moonshot to cure cancer,” a personal passion fueled by his son’s death from the disease. Half a year later, this tall-order still has the industry – and world’s – attention, remaining the cause of consistent speculation and debate.

  9. Are You Familiar With The Framework For First-In-Human Testing? 6/7/2016

    Although first-in-human dosing is a critical event in the clinical development pathway, Roger Mills believes few clinical trial personnel are familiar with either the theoretical or practical aspects of early human studies. A paper written by Jonathan Kimmelman titled “A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries” lays out some of those aspects.

  10. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016 6/5/2016

    Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo.