Clinical Guest Contributors

  1. Moving Your QMS Beyond (Current And Future) Regulatory Expectations: A 7-Step Process

    Currently, sponsors running clinical trials have established quality management system (QMS) frameworks inclusive of organizational structure, processes, and procedures on the following premise: The QMS helps maintain a company’s compliance to regulations, ultimately with the hopes of ensuring patient safety, product quality, clinical responsibility, and data integrity.

  2. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  3. Talent Wars: How To Develop A Competent Clinical Research Workforce In A Competitive Environment

    A booming economy brings opportunities, and the biotech industry is booming. But with that comes challenges, particularly with regard to finding qualified candidates to fill the growing number of jobs.

  4. Combatting The Professional Patient Problem In Clinical Trials

    Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll.

  5. Can ICER Help Design Clinical Trials But Stay Independent?

    According to a report, the Institute for Clinical and Economic Review (ICER) is considering offering a service, for a fee, to pharmaceutical manufacturers whereby ICER would provide guidance on clinical trial design.

  6. Are Regulatory Agencies Prepared For A Rapidly Aging Population?

    Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.

  7. What Do Sites Really Want From Sponsors And CROs? ACRP/Avoca Survey Explains

    The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from their perspectives. A total of 151 respondents assessed sponsor organizations and 130 evaluated contract research organizations (CROs). Respondents were asked to comment on up to three companies they’d worked with during the previous 12 months.

  8. What’s In A Name? Understanding Unmet Medical Need May Help Align Prioritization Strategies

    Unmet medical need (UMN) is not a new concept, but it is an increasingly important one. Regulators and payers are nudging the industry to steer R&D investments toward areas with higher unmet need and less crowded pipelines.

  9. Sites Need Technology, Infrastructure Investments To Improve Clinical Trials

    Our industry is unintentionally discouraging clinical research sites from investing in infrastructure. As a generalization, sites have the fewest resources of all the stakeholders involved in the successful execution of a clinical research trial. Most sites are very small and struggle to break even. Most sites have little to no IT infrastructure and can’t afford to build it. Most sites have staffing models where employees and physicians have too many disparate roles and responsibilities without the support or training to be successful. Employees are shared between research and non-research functions. The thin operating margins limit sites’ ability to build a meaningful, robust infrastructure, and this limits sites’ ability to be profitable.

  10. Virtual Registries: How To Bring Patient-Centricity Into Clinical Research

    Our rapidly increasing genetic-level disease knowledge and exponential technology advances are changing the way we manage health. But we may never fully seize these opportunities if we limit our clinical research approach to past models. Changing societal attitudes around sharing personal data and new consumer technology make innovative study designs and operations possible. This includes new possibilities in designing and operationalizing patient registries by moving to “virtual” setups.