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Safety is imperative in clinical trials – new drugs and devices, no matter how innovative, cannot get to market unless proven to be safe for those who will use them.
SynteractHCR's Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology, and medical device companies to effectively track and manage their products’ benefits and risks throughout the product lifecycle. We can provide our clients with end-to-end safety services from early phase through approval and post-marketing in two ways:
Experienced Staff Provides Safety Expertise
With expertise across multiple therapeutic areas, our safety staff of highly-trained professionals (including MDs, PharmDs, and RNs) is well-versed in safety reporting practices and regulations. Our flexible infrastructure allows us to adapt to your specific safety needs, from case processing and medical evaluation to submission of safety data to regulatory authorities. Sponsors select the level of involvement in the safety process suitable for your company and available resources.
Efficient Technology Enhances Your Study’s Performance
SynteractHCR utilizes two Oracle® Argus 7.0.5 modules for its safety database technology platform: Oracle Argus Safety and Oracle Argus Interchange. As an Oracle Gold Partner, SynteractHCR can offer Oracle Argus Safety as well as migrate safety data from legacy or discontinued systems.
We also utilize a validated, industry-accepted electronic (E2B) gateway, the Axway Synchrony Interchange platform, in conjunction with Oracle Argus. These technologies support safety surveillance for drugs, biologics, vaccines, and medical devices throughout the product’s life cycle offering:
In addition, such technology allows for rapid exchange of safety data among marketing partners, affiliates, and/or vendors while ensuring the integrity of the data. You will have timely access to your data.
Safety Surveillance Services are tailored to your specific needs and include:
Clinical Safety Services:
Additional Post-Marketing Safety Services:
Clinical Event Classification (CEC) Services:
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