Featured Articles

91. Choose The Right FDA Program To Expedite Your Rare Oncology Trial 6/28/2021

    With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. This blog post reviews the regulatory programs available to expedite treatments for rare disorders and serious diseases.

92. 5 Key Takeaways: Drug And Device Development Secrets In The World Of Medical Aesthetics 6/4/2021

    New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. Premier Research explored this evolving landscape in depth in our recent webinar Drug and Device Development Secrets in the World of Medical Aesthetics. In this blog, we discuss five of the most important takeaways for creating a competitive, differentiated aesthetic development program.

93. Pursuing Parkinson's Disease Gene Therapies: Strategies & Operational Requirements 5/28/2021

    While treatment of Parkinson’s disease has traditionally been limited to dopamine replacement therapy to alleviate symptoms, gene therapy studies have recently shown encouraging results for both non-disease-modifying and disease-modifying transgenes. Conducting these trials requires careful attention to investigator and site selection and adherence to local regulatory and protocol design requirements. The need for long-term patient follow-up puts added demands on patients and sites.

94. Market Application And Lifecycle Management: The Road To Commercial Success 5/28/2021

    Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your trial strategy?

95. The Emerging Biotech's Guide To Creating Scalable Infrastructure With A Functional Service Provider 5/27/2021

    For a biotech company, sudden growth can come in many forms. When your company finds it necessary to scale quickly while still maintaining complete oversight over every aspect of your study, partnering with a functional service provider (FSP) may be an excellent solution. Learn how a FSP can provide the expertise and instant infrastructure to move things ahead quickly while still retaining complete control.

96. Compensating For The Unknown: 3 Keys To Implementing A Successful Decentralized Clinical Trial 5/27/2021

    While the shift to DCTs is well underway, concerns remain around patient monitoring and engagement and data reliability and quality. In this blog post, we discuss three takeaways from our experience designing and implementing DCTs to help protect patient safety and preserve data quality.

97. Considerations To Improve Patient Outcomes In Early Drug Development 4/27/2021

    Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.

98. ePremier Study Start-Up: Where A Successful Trial Launch Begins 4/27/2021

    Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Watch this video to see how the Study Start-Up application delivers fast, efficient, and accurate trial management.

99. 5 Key Takeaways: Insights On Alternative Designs To The Traditional 3+3 Design In Phase 1 Dose Escalation Studies 4/26/2021

    During Premier Research’s recent webinar Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Abie Ekangaki, Vice President, Statistical Consulting, and Andreas Schreiner, Vice President, Medical Affairs, Neuroscience & Analgesia, discuss alternative dose-escalation paradigms introduced into the clinical trial landscape for Phase 1 trials. In this blog post, we share five of their key insights on alternative dose escalation strategies for Phase 1 studies.

100. Key Changes In The Revised EMA Guidance On Clinical Trials During COVID 4/26/2021

     In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.