BIG Language Solutions

For CROs supporting pharmaceutical development, language is not a final step. It is part of the submission strategy. EU Marketing Authorization Applications come with tight timelines, strict regulatory expectations, and high volumes of complex product information. When multilingual submissions, variations, and renewals are in motion, every word has to be accurate, consistent, and ready for review. That is where BIG Language Solutions supports CROs as more than a translation vendor. We work as an extension of your team, helping regulatory, medical writing, and submission teams manage language with confidence. Here’s what that can look like: 🔸 Seamless workflow integration, so translations fit directly into your submission process 🔸 Direct collaboration with your team, including support for regulatory questions, terminology, and formatting 🔸 Flexible delivery models, including white-labeled or co-branded support 🔸 QRD-compliant formatting for product information 🔸 In-country regulatory attorney review when required Our process is built for precision, with professional translation, bilingual editing, independent review, and careful formatting at every step. For CROs, that means fewer surprises, stronger consistency, and a smoother path from English product information to multilingual submission-ready content. Because in pharma, language quality is not just about words on a page. It affects timelines, compliance, and regulatory confidence. BIG helps CROs manage the high stakes of language in pharma with the expertise, responsiveness, and regulatory understanding the work requires. Ready to make your next submission smoother? Let’s talk: https://lnkd.in/eup2qEBC #CRO #Pharma #EU_MAA #Translation #LanguageAccess #RegulatoryCompliance

A member’s format preference should not get lost between enrollment and fulfillment. For California Managed Care Plans, DHCS APL 25-016 is a reminder that accessible communication has to work as a system. When a Medi-Cal member selects braille, audio, large print, or an accessible electronic format, that preference needs to move from the 834 enrollment file into the workflow that creates and sends member communications. That is where the process can get complicated. Who receives the data? What triggers production? How are files formatted, checked, produced, and delivered? LanguageExpress™ helps health plans connect those steps, supporting high-volume, regulated healthcare communication from translation through formatting, production, and direct-to-member fulfillment. BIG Language Solutions also supports large print, audio, accessible digital formats, and braille, backed by in-house braillists for quality and consistency. Because accessible communication is not just about having the right format available. It is about getting it to the right member, correctly, and on time. Read the full blog here: https://lnkd.in/d46Siwci #Accessibility #MediCal #LanguageAccess #HealthcareCompliance #AlternateFormats

BIG Language Solutions is headed to ITIC: International Travel & Health Insurance Conferences in Puerto Vallarta, Mexico, May 31–June 2. We’re looking forward to connecting with organizations that need reliable, secure, and scalable language access support across complex communications environments. At BIG, we help clients simplify multilingual communications across: 🔸 Translations 🔸 Over-the-Phone Interpretation 🔸 Video Remote Interpretation 🔸 Alternate Formats 🔸 Telehealth Interpretation 🔸 Operational Support + Workflow Management Stop by Booth 11 to meet our team and learn how BIG helps organizations Trust Every Word™ across interpretation, translation, localization, alternate formats, and multilingual communications. #ITICAmericas #LanguageAccess #Translation #Interpretation #MultilingualCommunications Johnny Mackay Caroline Dal Molin 

Regulatory submissions don’t leave much room for error. For CROs and pharma teams managing EU Marketing Authorization Applications, multilingual product information has to be accurate, consistent, QRD-compliant, and ready on deadline. That’s where BIG makes a difference. When Asphalion needed support for complex multi-language submissions, BIG stepped in as more than a translation vendor. We became an extension of the regulatory team. That meant: 🔸 Real-time guidance on terminology and EMA submission expectations 🔸 Translation workflows built around submission timelines 🔸 QRD-compliant formatting and review 🔸 Flexible white-labeled or co-branded support 🔸 Clear communication with regulatory, medical writing, and project teams The result? On-time submissions, no language-related rejections, and greater confidence across the process. When regulatory pressure is high, the right language partner helps reduce risk, protect timelines, and keep submissions moving. Planning an EU MAA submission? Read the case study here: https://lnkd.in/dnNhzzhi #CRO #Pharma #EU_MAA #Translation #LanguageAccess #RegulatoryCompliance ASPHALION

We’re here at Paving the Way to Health Care Access 2026. Today, we’re proud to be showcasing InterpVault™ and the role thoughtful technology can play in supporting stronger interpretation workflows. From faster access and simpler scheduling to better reporting and operational visibility, InterpVault™ is built to help organizations support qualified interpreters more effectively — not replace the expertise they bring to every interaction. If you’re attending, come say hello and take a look at how InterpVault™ helps make language access more connected, more manageable, and more human-centered. Mass Medical Interpreter Training UMass Chan Medical School Meredith Stegall Fernando Gargano Jeff Mercer #PavingTheWay2026 #HealthCareAccess #MedicalInterpreting #LanguageAccess #InterpVault #BIGLanguageSolutions

We’re looking forward to Paving the Way to Health Care Access 2026. At BIG, we believe better language access starts with the right people and the right support around them. That is why we’re excited to showcase InterpVault™ — a platform designed to make it easier for organizations to connect with qualified interpreters, streamline scheduling, and gain clearer visibility into interpretation services. For healthcare teams, that means less friction, faster access, and workflows that help interpreters do what they do best: support clear, accurate communication when it matters most. If you’ll be there, stop by to see InterpVault™ in action and learn how our micro call centers can help support your interpreter teams. Mass Medical Interpreter Training UMass Boston UMass Chan Medical School Meredith Stegall Fernando Gargano Jeff Mercer #PavingTheWay2026 #HealthCareAccess #MedicalInterpreting #LanguageAccess #InterpVault #BIGLanguageSolutions

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Smart language access in government is not about choosing between cost savings and quality. It is about knowing which resources belong where. BIG Language Solutions’ new guide, A 2026 Guide to Cost-Saving Language Access in Government, breaks down how public sector teams can reduce costs, improve efficiency, and maintain trust without weakening the services people rely on. The guide explores where language access programs often overspend today, including outdated systems, manual workflows, and high-cost resources being used for routine requests. It also shows what smarter resourcing can look like in practice: 🔸 AI-assisted workflows for repetitive, low-risk tasks 🔸 Human interpreters for high-stakes conversations in legal, medical, child services, and benefits settings 🔸 Human review for sensitive or regulated translations 🔸 Secure systems that protect PHI, PII, and agency data 🔸 Scalable workflows for notices, forms, letters, public information, and alternate formats The goal is not to replace human expertise. It is to protect it, so trained professionals can focus on the complex, emotional, and high-impact interactions where judgment, cultural understanding, and accuracy matter most. For government teams planning for 2026, this guide offers a practical look at how to modernize language access while staying aligned with policy, security, and community needs. Read the full guide here: https://lnkd.in/dGBZq8e5 #LanguageAccess #GovernmentCommunications #Translation #Interpreting #AI

We’re live at #RAPSEuroConvergence and would love to connect. If medical device translation is touching your regulatory, labeling, quality, or post-market workflows, stop by Booth #49 and meet the BIG team. We’re here to talk about how medical device and life sciences teams are managing multilingual content across regulatory, quality, and commercialization workflows. We’d love to hear what challenges your team is solving for right now. Regulatory Affairs Professionals Society (RAPS) Tim John Giuseppe Barra #RAPSEU #RegulatoryAffairs #MedicalDevices #LifeSciencesTranslation

We’re live at the 17th Annual Medicare Market Innovations Forum in Charlotte. Stop by Booth #2 to meet the BIG Language Solutions team and talk about clear, compliant member communications across languages and formats. We’re having great conversations around accessibility, language access, alternate formats, and support for high-volume periods like AEP. Strategic Solutions Network Colin Klevan Brett Gianna Hyatt Johnny Mackay #Medicare #HealthPlans #Payors #LanguageAccess #Accessibility #MemberCommunications #Compliance