In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.
A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.
Obstacles still remain in developing effective and efficient new targeted therapy agents, identifying the biomarker tests that indicate which patients will be responsive to them, and implementing them in clinical practice.
Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.
Understanding the non-invasive methods for assessing fibrosis range from biomarker assays to advanced imaging techniques such as transient elastography.
Applying ‘lessons learned’, innovative thinking, and creative problem solving to overcome unique challenges associated with conducting these studies.
This white paper explains the role of study design in RWE, key data sources for RWE-based approaches, and some unique considerations for RWE studies.
How enhanced state-of-the-art flow cytometry capabilities empower flexible approaches to global clinical trials across multiple therapeutic areas.
As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.
Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.
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