White Papers

  1. Eight Must-Know Considerations About Rare, Dermatologic Trials For Children

    Dermatology trials are somewhat unique, and even more so with children included in the trial. This white paper discusses some of the key considerations that should be taken into account when planning rare, dermatologic trials for children.

  2. Clinical Trials & Travel Tribulations: Improving Access And Outcomes For Patients And Caregivers, Sites And Sponsors

    In this paper, we dive into the logistical and financial challenges which increasingly impact all clinical trial stakeholders - from patients and sites, to sponsors and contract research organizations (CROs). Yet with proper planning and the right partners on board, travel arrangements and reimbursement programs can make the trial and patient experience more comfortable and successful for everyone.

  3. Biologics - The Key To Next Generation Dermatology R&D?

    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.

  4. Objectively Tracking Lesions In Dermatology Clinical Trials

    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.

  5. Commercialization Accelerator For Emerging Companies

    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.

  6. A Framework For Successful Pain Measurement In Clinical Studies

    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.

  7. Considerations For Clinical Studies In Migraine Prophylaxis And Treatment

    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.

  8. Considerations For Studies In Infectious Diseases Of The Genitourinary System

    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.

  9. Considerations For Clinical Studies In Heavy Menstrual Bleeding

    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.

  10. Capabilities For Clinical Studies In Contraception

    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.