Drug Safety/Pharmacovigilance Services & Products
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Medical & Regulatory Affairs
3/4/2016
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
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Pharmacovigilance System Master File
4/23/2013
One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.
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Global Multilingual Call Center
4/23/2013
TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).
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Safety Technology
12/21/2012
From smart, technology-driven products like our hosted Oracle Argus safety database, Oracle Interchange, Oracle Argus Insight, the Transperfect Trial Interactive safety portal, the UL Eduneering Training platform, EDC integrations, electronic data migrations, EasyCode™ Dictionary Management Tool and more to expert-infused services that deliver validation, CFR 21 Part 11 compliance, a technology support desk, system upgrades, and resolution to functional gaps to improve safety work flows, Sentrx’s Technology Services Group always delivers two essential outcomes: confidence and trust.
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Post-Marketing Drug Safety
12/21/2012
With our sophisticated full-service approach to post-marketing event handling (medical inquires, product quality complaints and adverse events), clients are assured that calls received from healthcare providers and / or patients and handled effectively and data obtained during a reported event are captured, stored and reported in a manner that not only ties all of the events together reported on a single call, but provides the best possible experience for the consumer.
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Clinical Product Safety
12/21/2012
Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.
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Adverse Event Management
12/21/2012
At Sentrx, we run the gamut, covering every aspect of pharmacovigilance for all stages of development and all sizes of clients. Whether your circumstances are more heavily influenced by clinical needs or post-marketing surveillance requirements or you are examining drug safety as part of your New Drug Application planning or preparing to implement risk mitigation strategies, Sentrx has the expertise to make your drug safety operations more flexible, cost-effective, and efficient.
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Adverse Event Reporting, Safety and Compliance Software
12/23/2011
Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.
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Pharmacovigilance Services
12/22/2011
Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
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Pharmacovigilance
6/24/2011
It's peace of mind -- and more. Global Safety AdvantageSM is an enhanced and seamless Global Safety Surveillance and Pharmacovigilance program.