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.
As the global reach of clinical trials has increased, and with the deadline for EU compliance quickly arriving, many in pharma are finding themselves in a dilemma.
With sponsors facing increasing pressure to reduce drug prices and bring therapies to patients faster, follow these tips to shorten your clinical development process.
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
Based on their survey of San Diego's clinical supply community, there are a lot of concerns around Brexit's impact on clinical supply. Sherpa took the top questions asked by their Sherpa Summer Seminar audience, and answered them in this Q&A.
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.
If you have questions about the most recent CDISC updates and what's needed for future regulatory submission, this webinar will provide answers.
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.
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.
With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience.