Clinical Guest Contributors

  1. Should You Bring Site Management And Monitor Oversight In-House?

    When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted.  The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.

  2. 3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

  3. Take A Page From Amazon’s Playbook To Transform Clinical Trials

    Since my first Amazon article, readers contacted me about Amazon-like transformations in clinical research. I never expected clinical research trends to emulate Amazon’s playbook.

  4. Designing Clinical Studies To Avoid Regulatory Scrutiny

    Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.

  5. Competencies And Credentialing And Certification …Oh, My!

    In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.

  6. Building A Stronger Community For Site-Based Research

    Leading a clinical trial at a research site as an investigator is a challenging task. Running a successful study requires the ability to manage budgets, coordinate the activities of support teams, efficiently allocate limited time and resources, and navigate the complexities of regulations and reporting obligations.

  7. Automated Site Payments: Key To Successful Engagement

    The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible. Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.

  8. Do Your Clinical Trials Suffer From Adoptaphobia Syndrome?

    Despite the focus on innovation at conferences, TED talks, and other forums in the last few years, as an industry we are still very slow to innovate and even slower to adopt new technologies, best practices, and methods.  This intense fear of adoption in our industry is what I affectionately call “adoptaphobia.” Adoptaphobia refers to our industry’s fear of and reluctance to adopting new initiatives, best practices, and technologies to create efficiencies and reduce redundancies.  We love to talk about issues and deliberate and discuss new methods, but we are extremely slow to commit and adopt the recommendations and methods that we agree would make everyone’s lives easier and streamline the process.

  9. What’s Behind The Gender And Ethnicity Imbalance In Clinical Trials?

    Boston Scientific deserves recognition for sponsoring the post-marketing PLATINUM Diversity study, a multicenter, open-label, single-arm, post-approval observational study focused on understudied populations: women, African-Americans, Latinos/Hispanics, American Indians, and Alaska Natives. PLATINUM Diversity enrolled 1,501 patients at 52 sites in the U.S.

  10. Key Shifts In The Latin American Central Lab Market

    Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.