Featured Articles
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Rare Disease Patients As Partners: Value Beyond Enrollment
3/8/2023
Learn why teams are putting an increased emphasis on creating processes and frameworks to encourage sustainable patient partnerships and establishing a paradigm of patient-centered research.
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How Patient & Caregiver Journeys Guide Rare Disease Study Designs
3/8/2023
Discover how designing trials that account for both patient and caregiver needs can improve the overall experience of study participation and may contribute to improved patient retention and higher-quality data.
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Can Your Protocol Flex? The Importance Of Adaptive Trial Designs In Precision Oncology Studies
2/9/2023
Discover how adaptive trial designs work to limit the number of patients exposed to ineffective doses or treatments and accelerate detection of efficacy signals.
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9 Design & Operationalization Tips For Early-Stage Precision Oncology Studies
2/8/2023
Early-stage clinical trials tend to focus on toxicity assessment and dose selection, which requires careful planning in study design and execution. Explore nine tips to improve precision oncology study processes.
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Navigating Regulatory Pathways For Digital Therapeutics
1/26/2023
This blog post will help sponsors gain clarity regarding what is and what is not considered a DTx and how to ensure they are following the correct regulatory pathway for their device.
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Seasonality: A Factor For Successful Patient Recruitment
1/26/2023
Managing clinical trials requires extensive planning of patient enrollment. Clinical trials may be more cost-effective with better forecasts of recruitment.
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The Rise Of Radiotherapeutics: Brief History And Best Practices For Clinical Trials
1/26/2023
Explore a brief history of radiopharmaceuticals and discover best practices for planning and executing clinical trials utilizing these novel drugs to treat cancer.
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Strategic Planning For Compliance With The EU Medical Device Regulation
11/29/2022
Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. Discover the key activities involved in strategic planning for this kind of compliance.
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Draft FDA Guidance Concerning Combination Products
11/29/2022
Explore how two new draft guidances clarify best practices for communication and provide a framework for identifying gaps in development programs that may result from the unique properties of the combination product.
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Medical Device Development: Pathways To Clearance Or Approval In The U.S. And Europe
11/29/2022
In this white paper, explore the development process, regulatory landscape, and pathways to approval for medical devices to help sponsors optimize the likelihood of commercial success.