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Keeping People Safe: Safety Services from SynteractHCR

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 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)

Clinical Safety Services:

  • Global safety plan development
  • Safety database development, management
  • Safety database hosting (Oracle Argus 7.0®)
  • Adverse event (AE)/Serious Adverse Event (SAE) case receipt, entry, processing
  • EudraVigilance registration and submission
  • Preparation of case narratives
  • Medical safety review
  • Reconciliation of SAE and clinical trial AE data
  • Development of regulatory reporting forms (MedWatch, CIOMS, etc.)
  • Preparation and submission of expedited and periodic safety reports
  • Preparation of periodic safety reports (DSUR, annual reports, etc.)

Additional Post-Marketing Safety Services:

  • Full case processing of AE/SAE reports (spontaneous, solicited, regulatory authority, non-sponsored trials, and literature)
  • Management of regulatory authority and safety partner reporting
    Perform safety database searches to support safety signaling activities as well as regulatory authority requests
  • Creation and submission of PADER/PSUR reports
  • Creation of sound conventions that satisfy regulatory needs yet optimize resources
  • Timely literature review for post marketed products

Clinical Event Classification (CEC) Services:

  • Identification and recruitment of CEC members
  • Development of CEC Charter
  • Collection and compilation of dossiers for Clinical Event Adjudication (CEC) review
  • Management of CEC meetings

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  • USA: +1 760 268 8200
  • Europe: +49 89 12 66 80 0
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