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SynteractHCR's Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology, and medical device companies in effectively tracking and managing their products’ benefits and risks from development through commercialization. Our flexible infrastructure allows us to adapt to your specific safety needs, from case processing, medical evaluation and submission of safety data to regulatory authorities. You can select the level of involvement in the safety process suitable for your company and available resources. And you will have timely access to your data.
Experienced Staff Provides Safety Expertise
With expertise across multiple therapeutic areas, our safety staff of highly-trained healthcare professionals (MDs, PharmDs, and RNs) is well-versed in safety reporting practices and regulations. Our team works with you to provide the necessary expertise in crucial areas of safety data collection, evaluation, management and reporting. Our ultimate goal is to deliver high-quality CRO services tailored to your specific program.
Efficient Technology Enhances Your Study’s Performance
SynteractHCR utilizes two Oracle® Argus 7.0 modules for its pharmacovigilance technology platform, Oracle Argus Safety and Oracle Argus Interchange. These two software modules provide a state-of-the-art technology backbone with a clean interface, strong redundancy and an efficient configurable workflow to support evolving client needs connected with major global product launches and post-marketing pharmacovigilance for drugs, biologics, vaccines, and medical devices. In conjunction, SynteractHCR will now offer Oracle Argus Safety database hosting on a SaaS (software as a service) model for clients who would prefer specialists to handle implementation, validation and maintenance of their safety database and technology infrastructure.
In addition, in 2011, SynteractHCR became the first Medidata CRO Service Partner accredited in Rave Safety Gateway, to efficiently perform the time-critical task of transmitting serious adverse event (SAE) data directly from a clinical database (EDC system) to the Argus Safety database, bypassing the need for manual re-entry of data into Argus.
Electronic Safety Data Exchange Ensures Compliance
Utilization of a validated, industry-accepted electronic (E2B) gateway, the Axway Synchrony platform, in conjunction with Oracle Argus, allows for 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 between marketing partners, affiliates, or vendors while ensuring the integrity of the data. As you take your products from pre-approval to post-marketing, from Phase I to Phase IV, SynteractHCR has the tools and expertise to handle all of your safety surveillance and pharmacovigilance needs. We provide the assurance to you, patients, doctors, and regulators that the evolving safety profiles of your products are maintained. Striving to meet your specific needs and committing to each project, at Synteract, it is always “Shared Work – Shared Vision.”
Safety Surveillance Services Include:
• Product safety consulting
• 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
• Preparation of case narratives
• Medical safety review
• Reconciliation of SAE and clinical trial AE data
• Development of regulatory reporting forms (MedWatch, CIOMS, etc.)
• Regulatory submission of expedited and periodic safety reports
• Preparation of periodic safety reports (DSUR, PSUR, PADER, etc.)
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