Insights On Trial Design

  1. The Role Of Observational Research & Patient Registries In Evidence Generation

    Increasingly central in the course of drug development is the inclusion of observational studies, including registries, which provide insights missing from traditional interventional studies.

  2. Pharmacy Services In A Phase I Clinical Research Unit

    This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.

  3. Tips To Avoid The Overuse of Edit Checks In Clinical Research Studies

    Follow these tips to avoid the overuse of edit checks and build better studies.

  4. EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market

    It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.

  5. Unlock Oral Delivery Potential For Macromolecules With A Parallel Screening Approach

    Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.

  6. Breakthrough-Designation Increases Stress On Clinical Supply Chain

    While Andexanet Alfa’s Breakthrough Designation added additional stress to the supply chain, Portola and Sherpa navigated these issues by devising fast, flexible and responsive approaches to supply chain management.

  7. Real-World Studies: Unique Considerations For Patient Engagement And Retention

    For methodological reasons, patient-centric study engagement and retention solutions appropriate for clinical trials may not always be suitable for real-world studies.

  8. Factors Driving Patient Adherence To Drug Therapy

    In the first annual Patient Adherence Influence Report, Adheris Health and inVentiv Health Consulting set out to understand the most influential factors driving patient adherence or non-adherence and to answer the question: Will the patient cross the finish line at the retail pharmacy, or will he or she walk away?

  9. 3 Recruitment & Retention Strategies That Can Save Your Trial

    Discover new strategies to ensure clinical trial recruitment and retention success when patient populations are small or protocols are burdensome.

  10. What's The Role Of A Data Manager In A Risk-Based Model?

    As companies recognize that RBM extends beyond just on-site monitoring to all types of data monitoring, your data managers, who ultimately are the steward of data quality and data integrity in a trial, are critical to the process and cannot be left out of the conversations.