GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Validation Study In Adults With Lifestyle-Related Chronic Disease

    The Philips Health Band (PHB) is a wrist-worn activity and heart rate monitoring device. This study assessed the measurement performance of the PHB in adults at risk for lifestyle-related chronic disease such as cardiovascular disease and diabetes type 2 as well as adults with existing lifestyle-related chronic disease.

  • Removing Barriers To Specialty Therapies

    Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals. Obstacles along each path can lead to increased turnaround time and drive script abandonment. Technology brings advancements for removing these barriers, but buyer beware.

  • Developing Gene-Based Therapeutics

    The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically – not just in the US but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

  • Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC

    Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

  • CAR-T Cell Therapies: Safety Considerations and Toxicity Management

    Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

  • The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research

    As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

CLINICAL TRIAL APP NOTES & CASE STUDIES

CLINICAL LEADER CONTENT COLLECTIONS

20_10_CL_ClinicalTrialsPandemic_Ebook_300x200

 

When the pandemic hit, many hospitals, clinics, and sponsor companies were caught by surprise. The effort to protect patients and keep them away from clinics put many trials in jeopardy. Amidst the chaos, sponsors and regulators were able to scramble and keep many trials going while considering the safety and needs of participants. In this collection of articles from Clinical Leader, learn how companies not only survived, but created new policies that will be tomorrow’s best practices.

More Content Collections

FOCUS ON PATIENTS

EMBRACING DIVERSITY & INCLUSION