White Papers on Clinical Research
Understand our clinical research process and how we contribute to building innovative CRO solutions.
Five emerging trends within the drug discovery/drug development paradigm are highlighted in this review – each reinforcing the need for therapeutically focused, methodologically rigorous, and highly efficient project teams for product evaluation and commercialization.
Significant and ongoing research into IMID pathology and genetic links have led to the knowledge that underpinning these diseases is the dysregulation of the immune system, which leads to widespread and chronic inflammation. These discoveries have delivered a more comprehensive understanding of immune-mediated mechanisms, and the promise for more effective treatments and possibly even cures for a range of IMID disorders.
Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies in man. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. Published in Dialogues in Clinical Neuroscience; copyright Association La Conférence Hippocrate – Servier Research Group.
Successful clinical development and commercialization of small molecules and biologics require that investigators, sponsors, and patients collaborate to preemptively facilitate study design, execution, and transition to commercialization.
The European Medicines Agency released the first guidance for biosimilar production in 2005. It facilitated the initial wave of registrations for human growth hormone, epoetin, and filgrastim biosimilars.
The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs subserving different objectives, and tiered in important and timing during the drug development cycle.
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