Pharmacovigilance Solutions

PV & safety teams are charged with ensuring adherence to regulatory and legal policies while putting patient safety above all else. TransPerfect supports these efforts with technology and services that help pharma, biotech, and med device companies ensure the safety of their patients by accelerating the time to report safety cases. 

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24/7 Support to Ensure Patient Safety Anytime, Anywhere

With the varying and often strict ICSR reporting timelines, it is imperative that serious adverse events (SAEs) are reported quickly to mitigate any potential harm to patients involved in trials. Our end-to-end services, paired with AI and technology for translation, help to reduce timelines for reporting events to the regulatory committees and ensure patient safety.

Why PV & Safety Teams Love TransPerfect

Our knowledge and experience in pharmacovigilance is evidenced by our ability to create and curate strategic solutions to improve day-to-day operations / reducing administrative burdens. We have 30+ years of experience customizing these solutions. Here are some of your options:

Literature Search

Improve your multilingual literature monitoring process with our comprehensive solution, which enables the collation, search, delivery, and translation of local and international literature (published and scientific) for adverse events.

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Call Center Support

Field non-English SA/SAE reporting with our world-class call center support division, TP Connect. With more than 100 global offices, we have helped many pharma companies quickly report and act on adverse events called in all over the world.

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AI Portal for Case Triage

Automate your translation process for faster turnaround times while also enabling your case processor to quickly prioritize incoming reports based on seriousness across 200+ languages.

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Language/Translation Solutions

Ensure conceptual equivalence and cultural appropriateness in any language, minimizing time-to-market, mitigating risk, and ensuring compliance in global studies.

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Training & Development

Whether your needs are temporary or ongoing, we help PV & safety teams select, test, train, and onboard multilingual staff to support outbound patient surveillance calls. Ensure your staff is trained with localized content and training materials for international markets, hosted in a 21 CFR Part 11 data room capable of generating reports on compliance.

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eClinical

Maintain compliance and enhance patient safety with the Trial Interactive PMSF solution. An easy-to-use, web-based format, our technology solution traffics safety notifications and distributes alerts in real time, ensuring that sites, sponsors, and CROs remain fully apprised of the latest information and data to meet good pharmacovigilance practices (GVP) and, of course, patient safety standards.

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Redaction

All safety reports contain personally identifiable information (PII) of patients. Protect patient safety and privacy with our redaction services prior to regulatory review.

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Medical Writing

When it comes to creating, managing, and translating safety content, medical writers play an integral role in protecting patient safety and adhering to strict regulations within tight deadlines. Our team of expert medical writers has in-depth knowledge of best practices for drafting and maintaining safety content, including PSURs/PBRERs, DSURs, RMPs, and more.

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Social Media Monitoring

Enhance patients’ real-world usage and feedback, including detecting potential adverse events, with multilingual social media monitoring.

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Trusted by Life Sciences Organizations Big and Small

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Industry insights from our experts. We have the experience and solutions you need to navigate life sciences complexity and bring breakthroughs from lab to launch.

eCOA Vendor Localization Best Practices Checklist

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up. It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance, and configurability. The investment of both time and money, not to mention protecting and upholding the integrity of the data collected, is critical when seeking regulatory approval and confirming ...

eCOA Vendor Localization Best Practices Checklist

Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up.  It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance...

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