Safety Expertise Across Your Project Life Cycle

Services: Safety Services

Safety Expertise Across Your Project Life Cycle

Services: Safety Services

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:

  • As part of a full service project
  • As discrete, standalone offerings.

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.

Oracle Gold Partner
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:

  • State-of-the-art technology backbone with a clean interface, strong redundancy and an efficient configurable workflow to support evolving client needs – used for full-service projects
  • Oracle Argus Safety database SaaS hosting for clients who do not have their own safety database and technology infrastructure
  • Axway facilitates secure submission of regulated data, such as individual expedited safety reports (ICSRs/SUSARs), to the FDA and health authorities in standardized ICH formats

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:

  • Safety Surveillance support for standalone contracts as well as full service
  • Product safety consulting (clinical and post-approval)

For a full overview of our suite of full-service and stand-alone safety surveillance services, click here or contact us today to speak to our safety services experts so they can answer any questions you might have.

Get in Touch

Global Headquarters:
5909 Sea Otter Place
Carlsbad, CA 92010

Phone: +1 760 268 8200
Fax: +1 760 929 1419

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