Clinical Trial Translations

Put our three decades of expertise and excellence in Life Sciences to work for you to ensure your clinical trials and pharmacovigilance will not be impacted by poor quality translations, delayed regulatory filings, or bloated costs. Facilitate critical data collection, market expansion, and help raise product awareness internationally with our specialized life science translation services.

BURG provides a full range of language and technology services to meet your needs throughout the product life cycle.

Clinical Trial Document Translation

Our team of expert medical linguists ensure the proper translation of all your clinical trial documents to keep your clinical trials moving forward.

Investigator’s Manual
Clinical Study Protocol
Case Report Forms (CRF)
Data Sheets
Dossiers
Patient Recruitment & Retention Materials
Patient Facing Documentation
Patient Diaries

Clinical Study Reports
Adverse Event Source Documents
Development Safety Update Reports
Drug Registration Documentation
Informed Consent Forms (ICF)
Patient Recruitment Materials
Labels and Instructions For Use (IFU) for trial products
Regulatory Correspondence

Flexible, white-glove service from your dedicated account team

You will have a hands-on, dedicated account team with deep knowledge of your account and unique requirements. We understand our clients have rush requests and challenges specific to the Clinical Trials industry. Our people, processes and technology allow us to cost effectively deliver your translations right, on time, the first time.

Regulatory

Our three decades of expertise in regulatory affairs translations and processes reduces your risks and ensures patient safety.

Packaging
Labeling/SmPCs
Package Inserts
Product Information
Patient Prescribing Information
Patient Information Leaflets (PILs)
Common Technical Documents (CTDs)
Regulatory Correspondence

Linguistic Validation

Our Linguistic Validation process, designed to meet FDA and other regulatory body standards, requires specific expertise, a detailed procedure, and accurate reporting. Our translations are accurate and culturally adapted.

COAs and eCOAs
Patient Reported Outcomes (PROs)
Clinician Reported Outcomes (ClinROs)
Observer Reported Outcomes (ObsROs)
Performance Outcomes (PerfOs)

Training & eLearning

Through the use of a centralized, end-to-end approach, we are able to execute the translation and publishing of all your compliance or other training and e-learning materials, regardless of platform.

Quizzes
Print based materials
Audio
Video
Slides
Ready-to-Publish SCORM-Compliant E-learning Courses

Marketing

Medical and pharmaceutical marketing requires specialized translators with knowledge of medical terminology and marketing expertise to find the right style, tone, and persuasive power.

Transcreation
Style Guides
Glossary Creation
Terminology Management
Website & SEO Localization
Graphics Localization
Marketing Assets
Sales Enablement
Desktop Publishing
Social Media
Multimedia

Medical Device

Hundreds of leading medical device companies count on our decades of expertise to deliver precise, accurate translations of the most technical of documents, on time, and on budget.

MDR Compliance Documents
Operating, Maintenance and Installation Manuals
Development Safety Update Reports (DSURS)
Software Applications and Documentation
Package Inserts and Labels
User Interfaces and Documentation
Patents for Medical and Surgical Devices
Manufacturing Process Descriptions
Suspected Unexpected Serious Adverse Reactions (SUSARs)

Related Services

As a full-service language provider, BURG offers related services to support all your clinical trials, and corporate HR, Marketing and Legal language needs.