Clinical Translation Services

Premier Clinical Translation Services

Stepes (/’steps/) provides best-in-class clinical translation services in over 100 languages. We combine technology-driven language solutions with our dedicated team of professional linguists, who possess extensive experience and subject matter expertise in various medical fields, to deliver accurate and high-quality translations for a wide range of healthcare-related content.

PAccurate Clinical Study Translations

Clinical Translations with Certified Accuracy

Are you a medical enterprise or healthcare organization in need of professional clinical translations to engage international customers? Stepes is a leading provider of clinical translation services, delivering accurate translations with efficiency to medical professionals, researchers, and patients of diverse linguistic backgrounds. As an ISO 17100 certified translation company, we understand the importance of compliance with regulatory requirements such as HIPAA, GDPR, and other international regulations. Our linguistic expertise, cutting-edge technology, and a deep understanding of the unique challenges in the healthcare industry allow Stepes to offer clinical translation services that are second to none. We facilitate seamless multilingual communication and collaboration across the global healthcare community, one accurately translated clinical document at a time.

One of the key differentiators of Stepes' clinical translation services is our utilization of advanced translation technologies, including AI-powered linguistic validation and translation memory systems. These tools enable faster and more cost-effective translations while empowering our human translators to ensure the highest level of accuracy and cultural appropriateness. Stepes also employs a rigorous quality control process, which includes multiple layers of editing and proofreading to guarantee the delivery of precise and reliable translations. We own one of the language industry's largest multilingual terminology databases. As one of Pfizer's official translation partners, we have translated over 100,000 medical terms for the healthcare industry.

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We Provide All Types of Clinical Translation Services

Stepes has the linguistic resources and localization processes to provide a broad range of clinical translation services, including linguistic validation, forward translation, back translation, linguistic reconciliation, cognitive debriefing, dual independent translation, machine translation post-editing (MTPE), terminology management, and more. The following is a list of clinical translation services we regularly provide to our clients:

  • Linguistic Validation
  • Forward Translation
  • Back Translation
  • Reconciliation
  • Cognitive Debriefing
  • Proofreading and Editing
  • Translation Memory Management
  • Terminology Management
  • Desktop Publishing (DTP)
  • Localization
  • Multilingual Project Management
  • Dual Independent Translation
  • Machine Translation Post-Editing (MTPE)
  • Video Remote Interpreting (VRI)
  • Medical Transcription
  • Subtitling and Voiceover Services

We Translate for All Stages of Clinical Studies

Stepes has extensive experience in translating technical content for every stage of international clinical studies involving multilingual patients and researchers. Leveraging our human expertise and intelligent translation management solutions, we provide clinical translation results that are faster, more accurate, and highly cost-effective. To explore Stepes’ comprehensive suite of clinical study translation solutions, please click here.

Study Design and Planning

Study protocol translation

Translation of documentation on identifying study objectives and endpoints

Documentation on sample size and participant selection criteria

Translation of selecting guides for study sites and investigators

Regulatory and Ethical Approvals

Investigational New Drug (IND) translation

Investigational Medicinal Product Dossier (IMPD) applications

Translation of supporting documents for approval by Institutional Review Boards (IRBs) or Ethics Committees (ECs)

Translation of guidelines on compliance with regulatory requirements

Study Setup and Initiation

Study-related documents, such as informed consent forms, case report forms, and investigator’s brochures

Training manual for study personnel and investigators

Plans for implementing data management and monitoring

Documentation of study logistics, including the supply of investigational products

Patient Recruitment and Enrollment

Document translation and interview interpretation on identifying and screening potential study participants

Translation of informed consent forms from eligible participants

Enrolling participants and randomizing them into study groups

Study Conduct and Data Collection

Translation of documents related to administering study interventions (e.g., drugs, medical devices, or other treatments)

Documentation translation on monitoring multilingual participants and collecting data on safety, efficacy, and other outcomes

Documentation on ensuring data quality and integrity through regular monitoring and audits

Data Analysis and Interpretation

Translation of the collected data

Documentation translation on conducting statistical analyses to evaluate study endpoints and assess safety and efficacy

Translation of study results in the context of the research question and existing knowledge

Reporting and Dissemination

Translation of study reports, such as Clinical Study Reports (CSRs), to regulatory authorities

Translation of study results for publishing in peer-reviewed journals

Presentation translation for findings at scientific conferences and meetings

Study Close-out and Follow-up

Translation of proper study documentation and multilingual information archiving

Patient communication translation for required long-term follow-up of participants

Translation of evaluation reports on the overall success and lessons learned from the study

Clinical Document Translation

Stepes’ clinical translation services encompass a wide range of healthcare-related documents in all European, Asian, and Latin American languages.

Medical Device Manuals

Medical Device Manuals

Translation of user guides, operating instructions, and maintenance manuals for medical equipment and devices.

Clinical Trial Documents

Clinical Trial Documents

Translation of COAs (clinical outcome assessments), informed consent forms, clinical study protocols, patient diaries, and case report forms.

Patient Information Leaflets (PILs)

Patient Information Leaflets (PILs)

Translation of patient education materials, drug package inserts, and instructions for use.

Medical Records

Medical Records

Translation of patient medical histories, discharge summaries, and diagnostic reports.

Regulatory Submissions

Regulatory Submissions

Translation of documents required for regulatory approval, such as drug applications, marketing authorizations, and safety reports.

Pharmacovigilance Reports

Pharmacovigilance Reports

Translation of adverse event reports, periodic safety update reports, and risk management plans.

Medical Research Articles

Medical Research Articles

Translation of scientific papers, research articles, and case studies for publication in medical journals or for internal use.

Medical Marketing Materials

Medical Marketing Materials

Translation of brochures, websites, and promotional materials targeting healthcare professionals or patients.

Medical Software and Apps

Medical Software and Apps

Translation of user interfaces, help files, and support documentation for medical software and mobile applications.

E-learning and Training Materials

E-learning and Training Materials

Translation of medical training courses, e-learning modules, and instructional videos for healthcare professionals and patients.

Medical Patents

Medical Patents

Translation of patent applications, claims, and prior art related to medical devices, pharmaceuticals, and biotechnology.

Medical Legal Documents

Medical Legal Documents

Translation of legal documents related to medical malpractice, informed consent, and patient privacy, among others.

In addition to the above documents, we also provide accurate translations of Clinical Study Protocols, Patient Reported Outcomes, Investigator Brochures, Drug Labels, Medical Safety Reports, Adverse Events, Case Report Forms (CRFs), Patient Surveys, Lay Summaries, Clinical Study Reports, Patient Recruitment Material, and Clinical Apps & Wearables.

Linguistic Validation

Linguistic Validation

Linguistic validation is one of Stepes’ most comprehensive clinical translation best practices. For mission-critical documents such as patient-reported outcome measures (PROMs), quality-of-life questionnaires, and clinical trial documents, linguistic validation is an essential translation methodology that ensures the highest linguistic accuracy, patient safety, and regulatory compliance. This meticulous process involves back translation, reconciliation, and cognitive debriefing to guarantee that translated content maintains its linguistic accuracy, clinical equivalence, and aligns with the stringent linguistic quality standards set by the global healthcare community. To learn more about Stepes’ linguistic validation solutions, please click here.

Need Professional Clinical Translation Support?

Call Us: +1 800-611-5698