Safety Expertise Across Your Project Lifecycle



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.

Synteract'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 clinical safety services from early phase through approval and postmarketing in 2 ways:

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

Experienced Staff Provides Clinical 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 clinical safety process suitable for your company and available resources.

Oracle Gold Partner
Efficient Technology Enhances Your Study’s Performance

Synteract utilizes 2 Oracle® Argus 7.0.5 modules for its safety database technology platform: Oracle Argus Safety and Oracle Argus Interchange. As an Oracle Gold Partner, Synteract 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 Safety with Oracle Argus. These technologies support safety surveillance for drugs, biologics, vaccines, and medical devices throughout the product’s lifecycle 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 standalone safety surveillance services, contact us today to speak to our safety services experts so they can answer any questions you might have.


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