Featured Articles

  1. Harnessing Critical Experience To Plan And Execute A Dual-Submission Study 3/8/2022

    Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost savings for payers. Yet, achieving regulatory approval can be daunting. Discover how a clear strategy was developed to ensure that the necessary data to support both 510(k) clearance and CLIA waiver would be collected within a single clinical trial.

  2. Ten Tips For Establishing The Clinical Utility Of Molecular Diagnostics: Stepping Stones To Precision Medicine 3/8/2022

    Healthcare payers, regulators, and other stakeholders increasingly focus on clinical utility when evaluating molecular diagnostics tests. Learn why this focus makes it vitally important for diagnostics developers to design and conduct trials that demonstrate the clinical utility of their tests.

  3. The Key To Streamlining Regulatory Approval For IVDs 3/8/2022

    Regulatory approval is the final hurdle sponsors face when launching an In Vitro Diagnostic (IVD). After spending many years and millions of dollars on development, find out how it can prove frustrating when the finish is in sight, but there are barriers to success.

  4. 8 New Elements Of The IVDR — And How To Change Your Approach 3/8/2022

    In this blog post, regulatory experts highlight eight new concepts in the published In Vitro Diagnostic (IVD) Medical Devices Regulation (EU) 2017/746 (IVDR) document and identify ways to think about IVD approvals to help prepare for the IVDR switch.

  5. Considerations For Clinical Studies In Heavy Menstrual Bleeding 2/4/2022

    Heavy menstrual bleeding (HMB) is one of the most common gynecologic disorders among women of reproductive age, accounting for up to one-third of all gynecologic office visits. Discover key operational and methodological considerations for heavy menstrual bleeding clinical studies.

  6. Teaming Up With Sites During Trial Design 2/4/2022

    This blog describes how effectively involving physicians and site staff during the trial design process can drive efficiencies that may improve recruitment efforts.

  7. Gaining Patient Input: How To Ensure Patient Interests Remain Top Of Mind 2/4/2022

    The focus on women’s health research means sensitivity to the concerns and needs of the female volunteers contemplating clinical trial participation. To effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process.

  8. Addressing Research For Women From Every Angle 2/4/2022

    When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. Explore trial considerations, including the unique needs, expectations and regulatory requirements of the female population.

  9. Addressing The Challenges And Opportunities In Gynecologic Cancer Research 1/12/2022

    With investment in research on the rise, explore the challenges investigators face in patient identification, site selection and the ever-changing regulatory landscape in the available webinar.

  10. Women-Centric Approach To Clinical Trials 1/11/2022

    Women are demanding more power, information, and control when it comes to their health. Learn how women now have a stronger voice when it comes to clinical research for treatments that impact their care.