Clinical Research Translation Services

Clinical Research Translation Services

For over 20 years Language Connections has been providing expert clinical research translation services for the medical industry. We supply multilingual support to major pharmaceutical companies and CROs, as well as numerous biotechnology and medical device firms around the world. We provide Clinical Research Translation Services to clients  that include Roche, CHDI, The Progeria Foundation, and Parexel.

We work with a variety of medical documents and provide translation of Informed Consent Forms, Pharmacological Studies and Clinical Trial Protocols, Patient Questionnaires and Adverse Events Report Forms.

As clinical trials increasingly go global, contract research organizations (CROs), biotech, pharmaceutical and medical device companies are seeing the opportunity for reduced costs, higher patient enrollment and the ability to collect data from a varied ethnic pool. With this comes a pressing need to understand and comply with varied and evolving international clinical research regulations.

Clinical Research Document Translation

Language connections offers clinical research translation services via textual, audio and visual translations for all stages of clinical research. We cover preliminary outreach, patient recruitment, regulatory approval of documents, safety reporting, as well as post-trial communication with the participants.

We provide clinical trial translation services for the following documents:

Pre-Trial Documentation

  • Pre-trial Marketing materials
  • Clinical trial protocols
  • Investigators Brochure
  • IRB/IEC documentation
  • Chemistry manufacture and control documents (CMC)
  • Material Safety Data Sheets (MSDS)
  • IND applications
  • Legal documents and related materials

Trial Documentation

  • Patient recruitment materials
  • Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs)
  • Adverse Event Reports
  • Patient Reported Outcomes Forms, Diaries & Surveys
  • Quality of Life Measures (QoL)
  • Clinical outcome assessments (including eCOA)
  • EDC information
  • Translation of IVR Prompts

Post-Trial Documentation

  • Follow up reports
  • Patient questionnaires
  • Participant correspondence
  • NDAs and MAAs

Packaging and Marketing

Linguistic validation and cultural adaptation

Language Connections recognizes linguistic validation and cultural adaptation as essential parts of a clinical trial process. We specialize in linguistic validation of Clinical Outcome Assessments (COAs), Patient Reported Outcomes (PROs) and Quality of Life Patient Questionnaires (QoLs). It is often required that CROs perform back translation, cultural adaptation and harmonization of the patient responses, to ensure accuracy and consistency across languages.

Our specialists have the in-depth expertise to guarantee that your materials will be culturally and conceptually equivalent in all languages, and that you will be in full compliance with regulatory authority requirements.

Interpretation Services

Some clinical trial processes require the assistance of trained linguists on-site or via remote connection to aid in communication. Language Connections provides rlinical research translation services, including certified interpreters for informed consent interviews, patient meetings, investigator meetings, and other instances where direct, oral communication with LEP individuals is needed.

Our clinical research translation services are designed to ensure:

  • More effective patient recruitment programs
  • Flawless regulatory submission
  • Enhanced global communication
  • Mitigated risks
  • Error free packaging and labeling
  • Timely IRB & EC review
  • Reduced time to market

Regulatory Compliance and Quality Control

Compliance with strict international regulations creates an urgent need for precise clinical trial translation, completed with an up-to-date knowledge of the industry and global markets. Language Connections works with linguists who hold advanced degrees in the Life Sciences and medical fields to meet the highest quality standards of clinical research and trial demands. Our translators follow distinct and strict methodologies for each document to ensure accuracy and proper layout.

CROs conducting clinical trials internationally have to conform to the requirements of the FDA, EMEA and other regulatory organizations and ethical committees. Regulators require that the patient recruitment materials, Informed Consent Forms (ICF), clinical protocols and other documents be in a language that is clearly understood by the people participating in the clinical studies. We have provided expert multilingual support to CROs, translating product labeling, clinical trial documentation, patient recruitment materials, as well as marketing and legal documents.

Confidentiality

Language Connections understands that medical and legal materials relating to clinical trials need to be kept secure. We provide our clients with a quality assurance program that guarantees confidentiality, and provide NDAs and secure client portals to ensure maximum security.

To Get More Information, Or To Request Clinical Research Translation Services:

Roche
Amgen
Bayer
U.S.  Environmental Protection Agency Logo
Alere
ABT Associates
CHDI Foundation
AstraZeneca
PAREXEL