White Papers

  1. Biologics - The Key To Next Generation Dermatology R&D?
    9/17/2019

    Biologics present new treatment options for dermatology patients who haven’t seen positive results from traditional treatment methods, such as topicals, phototherapy or traditional drugs. This paper explores the evolution of biologics within the dermatology landscape, with an emphasis on clinical trial considerations for sponsor developing biologic agents.

  2. Objectively Tracking Lesions In Dermatology Clinical Trials
    9/17/2019

    There is an increasing need for objectivity in mapping and analyzing of lesions to create confidence in trial findings, reproducibility and translation to clinical practice for dermatology sponsors, regulators and clinicians. This paper examines evolving diagnostic practices coupled with advancing technology and their application to reduce subjectivity in dermatology clinical trials.

  3. Commercialization Accelerator For Emerging Companies
    9/17/2019

    For any life sciences company bringing its first product to market, the “commercialization to-do list” is long and punctuated by one critical strategic decision after another. This guide explores lessons learned from industry leaders facing the challenges of building commercial operations capabilities and how they avoid pitfalls.

  4. A Framework For Successful Pain Measurement In Clinical Studies
    8/28/2019

    Due to its complex nature, designing a study that effectively measures pain intensity and/or relief can be challenging. Health Decisions offers these considerations based on previous experience managing pain trials.

  5. Considerations For Clinical Studies In Migraine Prophylaxis And Treatment
    8/28/2019

    Migraine is a neurological disorder that compromises quality of life and is disabling for a large, predominantly female population. Read more about the important considerations, risks and mitigations in migraine studies.

  6. Considerations For Studies In Infectious Diseases Of The Genitourinary System
    8/28/2019

    There is a substantial need for novel therapeutics for infectious diseases of the genitourinary system. Learn more about the requirements along with the key risks and corresponding mitigations in the studies of diseases of the genitourinary system.

  7. Considerations For Clinical Studies In Heavy Menstrual Bleeding
    8/28/2019

    Clinical trials of therapeutics for HMB involve unique operational and methodological considerations including defining eligibility requirements, proper training, and accurate measurements to name a few. Read more about these considerations as well as key risks and mitigations in HMB studies.

  8. Capabilities For Clinical Studies In Contraception
    8/28/2019

    Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.

  9. Addressing The New Imperative To Include Females In Clinical Trials
    8/27/2019

    As a leader in women’s health research, Health Decisions has extensive experience in recruitment of female subjects for trials in a variety of indications, including but not limited to women-specific indications. Health Decisions is pleased to share some lessons from our experience in women’s health studies to assist sponsors in increasing female participation in studies across the therapeutic spectrum.

  10. Ten Tips For Establishing the Clinical Utility Of Molecular Diagnostics
    8/27/2019

    The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. What diagnostics developers may fail to consider in planning a trial to demonstrate clinical utility is the complex sequence of activities that are necessary to transform the result of their new test into an improved health outcome. The following tips for establishing clinical utility of molecular diagnostics studies address a variety of issues with particular attention to the requirements of conducting RCTs to provide evidence of changes in treatment decisions and health outcomes.