Pharmacovigilance Solutions

PV and 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

24/7 Support to Ensure Patient Safety Anytime, Anywhere

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

News and Press Releases

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.

Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities

Blog

The European Commission’s proposed Biotech Act introduces changes that could reshape how clinical trials are approved and managed across the EU. While the broader package spans multiple areas of the health ecosystem, proposed updates to the EU Clinical Trial Regulation (EU CTR) stand out for their potential to address long-standing operational challenges including lengthy timelines, limited flexibility in submissions, and fragmented processes across member states. ...

Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities
Checklist

A Checklist for eCOA Solution Deployment: Best Practices and Considerations

Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the ...
Success Stories

Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions

This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for ...
White Paper

Successful English Build & Language Migration

Over the past decade, the global clinical trial landscape has changed drastically. A surge in technological innovation, including wearable devices, patient portals, and apps, has modernized how clinical data is collected and managed. With pen and paper becoming obsolete in the ...
Blog

Why 75% of Medical Device Manufacturers Are Disappointed with Their AI Results

The Gap "The results we're seeing from AI are only as good as the data and structure we put behind it. Most manufacturers haven't done that work yet." — Marc Miller, Division President, TransPerfect Medical DeviceArtificial intelligence has arrived in medical device...
Blog

Metadata In, Metadata Out: Reducing RIM Submission Rework with In-System Translation

Pharmaceutical companies spend billions and take years to bring therapies to market. Then many risk it all on a translation process managed with spreadsheets, email chains, and blind faith. Every label update, every safety amendment, every regulatory change notice must be...
Blog

AI Content Creation and Maintenance in Medical Information: Ending the Content Whack-a-Mole

For many medical information (MI) teams, content maintenance can often feel like a game of whack-a-mole.Update one answer, three more pop up. Fix a regional version, and another channel drifts out of sync. Add a new piece of literature, and suddenly every approved response...

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