|
|
|
|
The release of the ICH E6(R3) Good Clinical Practice guideline in January 2025 marks a transformative shift in clinical research, with significant implications for CROs, trial design, and quality management. The updated guidelines emphasize a risk-based, proportionate approach to trial management while integrating technological advancements.
|
|
|
|
|
Contract research organizations (CROs) are essential in advancing immuno-oncology (IO) clinical trials, as cancer research becomes increasingly complex. Learn about the key criteria that sponsors should evaluate when selecting a partner for your IO trials.
|
|
|
|
|
Despite challenges, regulatory bodies are addressing technical issues and exploring legislative changes to integrate additional product categories into CTIS. The CTR and CTIS represent a paradigm shift in European clinical research, and ongoing refinements aim to maximize the system’s benefits, ensuring Europe remains competitive in global clinical development.
|
|
|
|
|
Immunotherapy has transformed oncology by leveraging the body's immune system to target cancer cells more effectively. While the field is rapidly evolving with research into combination therapies, predictive biomarkers, and personalized treatment approaches, challenges such as immune-related adverse effects, accessibility, and cost barriers remain.
|
|
|
|
|
Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models to ensure these therapies become an accessible and viable treatment option for rare disease patients.
|
|
|
|
|
A Phase III combination study for neovascular age-related macular degeneration (AMD) was initiated by a small U.S. biotech company to evaluate the safety and efficacy of an investigational intravenous therapy. Given the study’s complexity, TFS HealthScience played a critical role in ensuring its success.
|
|
|
|
|
A European biotech sponsor developing an ADC therapy for advanced solid tumors faced significant challenges in conducting an adaptive Phase I/II dose escalation and expansion study in the U.S. To ensure a seamless trial execution, the sponsor partnered with TFS HealthScience, leveraging its global capabilities and early-phase oncology expertise.
|
|
|
