Clinical Trial Translation Services
Ensuring linguistic accuracy and regulatory alignment across all clinical trial materials
Biomedica’s clinical translation process is structured to support the regulatory and quality expectations governing global clinical trials. Our workflows are designed to ensure accuracy, consistency, traceability, and documentation—critical elements in regulated research environments.
Each clinical project begins with a documented scope review to determine study phase, target regions, submission requirements, and applicable regulatory standards (e.g., ICH-GCP and regional health authority expectations). Based on risk level and document type, we assign senior linguists with a minimum of 10 years of clinical translation experience and relevant therapeutic expertise.
Our process includes:
-
Terminology alignment using client-approved glossaries and prior submissions
-
Translation by qualified clinical subject-matter linguists
-
Independent bilingual review for accuracy and regulatory consistency
-
Structured Quality Assurance checks, including terminology validation, numerical verification, and formatting review
-
Documented change tracking and version control
We maintain clear audit trails, secure file handling procedures, and controlled workflows to support inspection readiness and regulatory transparency.
By combining experienced clinical linguists with documented, multi-layer review procedures, Biomedica delivers translations that support submission integrity, patient safety, and global regulatory expectations.
A Trusted Language Partner
Biomedica provides clinical translation services tailored for regulated life-science environments. Each project follows a structured, documented workflow to ensure scientific accuracy, terminology consistency, and alignment with global regulatory requirements.
Types of Clinical and Medical Documentation
- Study Protocols
- Protocol Synopses
- Informed Consent
- Investigator Brochures
- Patient Surveys
- Patient Reported Outcomes
- Patient Records
- Case Report Forms (CRF)
- Clinical Outcomes Assessments (COAs/PROs)
- Contracts
- eCOA/ePROs
- Adverse Event Reports
- Ethics Correspondence
- Drug Labels
Experienced Linguists with Medical Expertise
Biomedica assigns clinical trial translations exclusively to linguists with demonstrated experience in clinical research, regulatory documentation, and therapeutic-area specialization. Our team understands the scientific, ethical, and regulatory sensitivities involved in translating trial-related materials.
Our Clinical Linguists
- Native-speaking professionals with life science or medical backgrounds
- Possess 10+ years of life-science translation experience
- Maintain terminology consistency across multi-country, multi-phase trials
- Operate within structured QA workflows designed for regulatory readiness
-
Degree or Equivalent professional background in translation, medical, or life sciences
Leading Life Sciences Organizations Rely on Us
We appreciate the high-quality translation of our clinical studies and your team all being on call for this. It will be a great benefit to patients around the world. You are true professionals.