Multilingual Solutions at Global Scale

Welocalize Life Sciences translates clinical, medical, healthcare and regulatory documents to and from more than 225 languages. We have over 20 years of experience working with leading global pharmaceutical, biotechnology, medical device, and healthcare companies.

  • More than 26 million words translated annually
  • Over 15,000 projects annually
  • Completed 155 clinical studies with 60 different sponsors
  • History of 99% on-time delivery
  • Experience in dozens of therapies
  • Language solutions for all stages from patent through commercialization

HIGHEST QUALITY + ACCURACY

Clinical Trials

Clinical trials are becoming ever more complex, diverse and globally distributed. Trials are conducted in more countries to reach a larger number of patients across a wider variety of ethnicities. Anything contract research organizations (CROs) and sponsors can do to reduce the time and cost of a trial, streamline communications and increase patient engagement means therapies can be evaluated more rapidly and reach people faster.

A trial, particularly a large, global trial, needs experienced language partners with robust technology solutions that can help coordinate, track and streamline processes while improving patient and study communications and study outcomes.

Welocalize Life Sciences provides professional translation and cross-cultural adaptation of clinical study documents into over 225 languages for use in global clinical studies. We have more than 30 years of experience providing clinical trial translation and interpreting services to sponsors, CROs and medical device manufactures. Our professional, native speaking translators and interpreters have medical degrees and experience in the target therapy or device.

Therapeutic Expertise Includes:

  • Cardiology
  • Central Nervous System
  • Dental
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genetics
  • Hematology
  • Immunology
  • Infectious Diseases
  • Neurology
  • Obstetrics/Gynecology
  • Oncology
  • Orthopedics
  • Pediatrics
  • Pharmacology/ Toxicology
  • Psychiatry/ Psychology
  • Pulmonary/ Respiratory
  • Rheumatology
  • Vaccines

We provide full translation and localization for all clinical research and regulatory affairs content and media, including:

  • Case Report Forms (CRFs)
  • Product Manuals + Labeling
  • Packaging + Inserts
  • Pharmacological Studies
  • Informed Consent Forms (ICFs)
  • Clinical Trial Protocols
  • Regulatory Documents
  • Advertising + Marketing Materials
  • Instructions for Use (IFUs)
  • Patient-Reported Outcomes (PROs)
  • Quality of Life (QoL) Measures
  • Scientific + Technical Articles
  • Patents + other IP Documents
  • Corporate + Investor Relations Documents
  • Patient Recruitment Materials
  • Product Manuals

Patent Recruitment + Marketing Solutions:

  • Patient Brochures
  • Patient Recruitment Ads
  • Physician Letters
  • Patient Surveys
  • Posters + Flyers
  • Social Media Posts
  • Retention Booklets
  • Product Brochures
  • iPhone Applications
  • Advertisements + Websites

SUCCESSFUL MULTINATIONAL CLINICAL TRIALS

Linguistic Validation

Global clinical trials result in multiple vendors across multiple global sites treating patients from a variety of cultures speaking different languages. Diverse cultures and languages add significant complexity to the clinical trial process. Welocalize Life Sciences provides professional translation and linguistic validation of Clinical Outcomes Assessments (COAs) into over 200 languages for use in global clinical studies. Our life science industry focus has made us experts in translating clinical documents for use in global clinical trials.

While every translation should have high quality standards, some types of translation, such as the those for patient-facing materials in a clinical trial, require more steps. Linguistic validation and cognitive debriefing ensure that all components of COAs are interpreted in the same way across diverse populations and are conceptually equivalent across multiple languages and cultures. These extra steps guarantee translation quality and allow for study data to be pooled and compared.

Our rigorous methodologies include:

  • Forward and back translations
  • Cognitive debriefing and focus groups to determine equivalence of concept
  • Local language adaptations

These methodologies ensure:

  • Instruments are culturally relevant and acceptable to the target population within each country
  • Language versions are conceptually equivalent to the original instrument and to one another
  • Instruments are psychometrically comparable

We have more than two decades of clinical trial translation expertise. Some of the documents we translate include:

  • Abstracts + Manuscripts
  • Clinician-Reported Outcomes (ClinROs)
  • Patient-Reported Outcomes (PROs/ePROs)
  • Observer-Reported Outcomes (ObsROs)
  • Clinical Outcomes Assessments (COAs/eCOAs)
  • Patient Diaries

Without linguistic validation and cognitive debriefing, clinical research trials are in danger of being rejected due to patient misunderstanding of poorly translated clinical instruments. Welocalize Life Sciences has a proven track record of successfully supporting multinational clinical trials in every major therapeutic area from early stage through commercialization.

Linguistic Validation of Clinical Outcomes
Assessments (COA)

Translatability Assessment
Dual Forward Translation
Analysis and Reconciliation
Back Translation
Harmonization
Cognitive Debriefing, Clinician Review
Proofreading
Final Report

GLOBAL REACH + COMPLIANCE

Regulatory Affairs

Welocalize Life Sciences’ extensive experience in the fast-moving regulatory affairs space makes it possible for us to successfully help our clients navigate the process and ensure compliance with local language requirements.
Welocalize Life Sciences has extensive experience working with regulatory agencies around the globe, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA). We work regularly with the EMA centralized and decentralized requirements and its Quality Review of Documents (QRD) working group.

Our team of highly-qualified, experienced language professionals work within a framework of regulated processes and robust quality-control systems to provide translations that get your products on the market faster while mitigating risks.
We adhere to a strict quality control process that follows the linguistic review guidelines established by the regulating agencies.

Some of the regulatory documents we translate include:

  • Summaries of Product Characteristics (SPCs)
  • Product Information Leaflets (PILs)
  • Labeling + Packaging
  • Marketing Authorization Dossiers
  • Marketing Authorization Variations
  • Manufacturing + Packaging Guides
  • Validation Protocols + Reports

Pharmacovigilance Expertise

Pharmacovigilance is a vital part of the drug and device safety process. Collecting data on any adverse events that take place, and reporting these to health authorities, is a critical component of effective and safe outcomes. It is imperative that pharmacovigilance and drug safety documents are translated to convey the meaning precisely. Welocalize Life Sciences is able to meet the tight pharmacovigilance reporting turnaround times requested by health authorities to ensure any adverse events/reactions are reported in a timely manner.

Pharmacovigilance translation is highly specialized. Welocalize Life Sciences has over two decades of experience translating the following pharmacovigilance documents:

  • Serious Adverse Event (SAE)
  • Suspected Unexpected Serious Adverse Reaction (SUSAR)
  • Periodic Safety Update Report (PSUR)
  • Development Safety Update Report (DSUR)
  • Medical Records
  • Hospital Discharge Summaries

Premium Services for Life Sciences

Our technology speeds up the translation process by 25%

Three-point quality assurance process ensures best possible deliverables

30+ years expertise in the Life Sciences industry

Let’s Talk About Your Next Project

REQUEST A QUOTE