CLINICAL TRIALS ARTICLES

  • Can CROs Rise To The Patient Access & Recruitment Challenge?

    It is not surprising that the task of CRO selection is often stress-inducing. One element we explore in depth is the influence of preferred provider agreements or the lack thereof. We ask clinical development outsourcers about the attributes they focus on under three selection environments.

  • The Benefits & Challenges Of Head-To-Head Trials

    In Lilly’s immunology portfolio, eight different H2H clinical trials have been conducted thus far. Four of those trials were conducted in parallel with a Phase 3 trial and four were conducted after it. Although the benefits are attractive to a sponsor company, H2H trials can present some unique risks.

  • A Quick Transition From Research Firm To Clinical-Phase Biotech

    Since Oct. 2018, Anne Whitaker had to figure out how to transition Aerami Therapeutics from a research firm to a clinical-phase company. It’s been a complicated and challenging journey.

  • eConsent In Clinical Trials: Insights For Implementation During COVID-19 And Beyond

    Many sponsors are quickly learning to adapt to the COVID-19 environment by providing virtual tools for clinical trial use. One example of an important tool in this space is eConsent.

  • DIA And CRO Leadership Awards Go Virtual

    The team behind DIA’s Annual Meeting was able to put together an event that was as informative and engaging as past years, despite the short and very hectic time frame. More than 200 sessions took place virtually, with 120 of those being on demand.

  • 5 Bad Habits The Clinical Trial Community Needs To Break ASAP

    I won’t attempt to address or solve all of the problems that contribute to the high cost of clinical trials, but I will highlight some continuing root causes that I believe persist needlessly.

  • 3 Essential Considerations For Running Global Clinical Trials

    In this article we'll look at three key considerations when designing a global clinical trial: selecting the most appropriate trial sites with a representative patient population, choosing to work with the right partners, and ensuring you are up to speed with local regulatory and clinical requirements.

  • A Small Biopharma’s View Of Working With CROs

    Running a clinical-stage oncology biopharma with only five employees means you quickly learn a thing or two about the value of outsourcing services. For Pamela Contag, Ph.D., cofounder and CEO of BioEclipse Therapeutics, those learnings have led to her company using five CROs for the company’s lead investigational candidate.

  • Transformative Reflections On The Life Science World, Post-COVID-19

    I’m reflecting on life after COVID-19, a couple years out — based on need and capacity to respond. While unorthodox, reflecting on a future possible outcome offers insight to the achievable and the opportunity to prepare for future clinical needs using current expertise and treatments.

  • A Small Biopharma That Doesn’t Use CROs

    When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. That is what makes Martin Lehr, CEO of Context Therapeutics different. He prefers to bypass CROs and take part in Investigator-Sponsored Trials (ISTs).