Insights On Trial Design

  1. Business and Cultural Considerations When Managing Clinical Supplies for Asia-Pacific Studies

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  2. Addressing Placebo Response, Therapeutic Misconceptions And Expectations

    Improving outcomes in clinical trials and reducing the trend toward high placebo response across different therapeutic areas requires the involvement of multiple stakeholders.

  3. Removing Barriers To Specialty Therapies: Technology Brings Advantages, But Buyer Beware

    Learn about the latest healthcare technologies and standards, including what they can and cannot do, to streamline patient access to your specialty therapy. New technologies can significantly reduce the time to fill, and increase patient adherence with your specialty medication.

  4. Looking Ahead To 2018: Insights Into Clinical Research Trends From Industry Experts

    In this paper, some of our thought-leaders provide their insights on what they are watching for and what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.