Industry Insights

  1. Not Just Tiny Humans: Considerations For Conducting Pediatric Clinical Trials
    4/28/2017

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, planning ahead for appropriate site conducting clinical studies in pediatric patient populationsand subject selection will take you one step closer. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

  2. Starting A New Conversation In Mental Health
    4/26/2017

    To improve care, we need more wide-ranging discussions among patients, payers, physicians and pharmaceutical companies

  3. Electronic Investigator Site File: The Solution for Disaggregated Industries
    4/26/2017

    Over the past several years, we’ve seen drug developers drop the blockbuster-era dream of fully-integrated pharmaceutical companies in place of an externalized, networked model of R&D.

  4. Secure Technology for Clinical Trials
    4/26/2017

    After being asked by a blog follower what type of technologies are used in the clinical research industry, I began to look back at my research clinic startup days in 2005. With an off-the-shelf program called “My Mail List” that I purchased from Staples to keep track of patient contact information, I guess it’s safe to say I had a rough start. Always having the philosophy of bootstrapping, and finding bare minimum solutions to get the job done doesn’t usually guarantee Health Insurance Portability and Accountability Act (HIPAA) or FDA CFR Part 11 compliance. Fast forward to present day 2015 and plenty of free and inexpensive solutions are now available.

  5. Remote Monitoring Versus Risk-Based Monitoring
    4/26/2017

    Remote monitoring and risk-based monitoring. There has been a lot of confusion recently around these two buzzwords.

  6. 3 Ways To Avoid The Hidden Costs Of EDC Training And Support
    4/19/2017

    It has now been several decades since EDC was first introduced as a tool for data management in clinical trials. In that time, boosted by continuous developments and enhancements, the technology has grown from a somewhat esoteric alternative to paper to a standard considered essential throughout most of the industry. Without thorough and comprehensive training and support resources, though, it will be a challenge for today’s EDC users to fully benefit from the capabilities the technology has developed over the years. While the best EDC systems are defined by simplicity and intuitiveness, they still offer an intricate array of functionalities that require a certain level of instruction in order to access.

  7. What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?
    4/19/2017

    Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.

  8. The Vanguard of Patient Centricity: Patient-Led Clinical Trials
    4/12/2017

    Amid the AIDS epidemic during the late 80’s, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, found himself at a crossroads. As a long-time proponent of the traditional “research to approval” drug development model, involving randomized clinical trials and lengthy regulatory reviews, Fauci was faced with the realization that this traditional approach would be of little benefit to AIDS patients without the luxury of time. Something had to be done. But what?

  9. EMA Guidance On Risk Management Plans (RMPs) In The EU
    4/5/2017

    On Friday, 31 March 2017 the EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev.2).

  10. The Pulse On Clinical Study Startup
    3/30/2017

    Clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data and sponsors/CROs are looking for ways to incorporate Business Intelligence into the eClinical systems they are using to empower oversight — turning raw trial data into actionable information.