Annual Reports/DSUR/PSUR Services & Products
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Medical & Regulatory Affairs
3/4/2016
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
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Post-Marketing Drug Safety
12/21/2012
With our sophisticated full-service approach to post-marketing event handling (medical inquires, product quality complaints and adverse events), clients are assured that calls received from healthcare providers and / or patients and handled effectively and data obtained during a reported event are captured, stored and reported in a manner that not only ties all of the events together reported on a single call, but provides the best possible experience for the consumer.
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Clinical Product Safety
12/21/2012
Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.
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Pharmacovigilance Services
12/22/2011
Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
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Pharmacovigilance
6/24/2011
It's peace of mind -- and more. Global Safety AdvantageSM is an enhanced and seamless Global Safety Surveillance and Pharmacovigilance program.
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Product Safety And Pharmacovigilance
A team of physicians, nurses, and pharmacists
Throughout the life cycle of the program, Product Safety ensures timelines are met in global safety reporting in clinical trials, supports and educates site staff, and provides a safety profile through management and analysis of the safety data as part of their pharmacovigilance services. Our experienced, highly trained safety team is composed of physicians, registered nurses, clinical pharmacists, and medical technologists. These safety and surveillance experts specialize in the collection, evaluation, and submission of safety data in clinical trials. The cornerstone of all of the Product Safety services is the concise and rapid exchange of safety information among all parties.