What is the government doing to improve the affordability, accessibility, and appropriate use of prescription drugs.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?
Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.
Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
How technology-based imaging improves quality and regulatory compliance, and how these improvements benefit sponsors.
In this webinar, INC Research/inVentiv Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
See how a life sciences organization uses CoSign to securely and compliantly sign an FDA form.
Get your trials up and running faster and your products to market more quickly. Learn how Startup InSite™ technology and the CFS Clinical Contract and Regulatory Services team speeds up the process.
Contracting an in-country clinical depot helps bring costs and timelines under control.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.