Clinical Guest Contributors

  1. 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs

    In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

  2. A Patient-Centric Approach To Increase Recruitment And Retention In Clinical Trials

    Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.

  3. Biopharma Precompetitive Collaboration: Optimizing Clinical Trial Quality, Efficiency, & Excellence

    Developing new, innovative pharmaceutical agents to address global health needs is becoming more complex, challenging, and costly. As the industry attempts to adapt and gain value for patients, healthcare providers, and other stakeholders, technologies, digitization, real-world data, immediate access to clinical trial data, and the adoption of wearable devices provide both opportunities and challenges. Disparate attempts to incorporate these capabilities across pharma, biotech, contract research organizations (CROs), regulators, and investigative sites create confusion and frustration while frequently adding unintended costs and quality issues.

  4. How To Spec, Purchase, And Implement The Right IRT System For Your Clinical Trial

    During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology. Take a deeper dive into key considerations when selecting a vendor, strategies to implement during the IRT design phase, and best practices for utilizing the system throughout the life of your trial.

  5. An Insider’s Guide To Interactive Response Technology (IRT) For Clinical Trials

    During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology. An experienced project manager shares some lessons he has learned to empower clinical team members to make better decisions when it comes to this crucial technology and in the end develop better and safer systems.

  6. Considering The Needs Of The Caregiver In Drug Development

    There has been an increasing and requisite focus on the needs of individuals affected by chronic or life-limiting disease, which has in turn resulted in a focus on the development of possible interventions and how they are administered. The success of participation and retention of these patients in clinical research, advancement of the drug development process, and adherence post-commercialization require the involvement of another critical expert — the caregiver.

  7. eTMF: A Paperless Paradise … Or Paradise Lost?

    The quest to eliminate paper, both outside and within clinical research, is filled with ironic and unexpected consequences. Consider Amazon, a tech leader with a market capitalization today of more than $800 billion dollars. The company was founded in 1994 as an online retailer of physical paper books, but in 2007, i.t launched the Kindle e-reader to eliminate the need for bulky, heavy, dusty, old-fashioned tomes.

  8. What CRAs Have To Say About Their Jobs And Their Mental Health

    This article is the second in a four-part series that investigates the disillusionment clinical research associates (CRAs) feel with their role today, why they feel that way, and what we can do about it. I surveyed almost 800 CRAs and line managers (LMs), and Part 1 explained the reasons I conducted this research. In Part 2 we dive into the survey results, looking at what CRAs said about burnout and their mental health.

  9. The Benefits And Challenges Of Siteless Clinical Trials

    The costs of drug development have increased exponentially over the years, while clinical trial participation and retention have decreased.1 Sponsor companies are seeking new and innovative ways to reduce costs while increasing patient participation by becoming more patient-centric. One such method is through designing a "siteless" trial. Siteless trials offer convenience to patients while being cost-efficient for sponsors.

  10. Stop Talking & Start Taking Action: 3 Ways To Improve Patient Centricity In Clinical Trials

    Every biopharma company talks about putting the patient at the center of everything they do, incorporating the voice of the patient and being patient-centric. However, very few companies are actually doing it. Why is it so hard to conduct clinical development in a patient-centric manner? What actions can we take in 2019?