Clinical Research Translation Services
Drive clinical research forward with fast, AI-optimized translations tailored for CROs. Our regulatory expertise ensures accurate, compliant translations, keeping your trials on track and timelines intact.
Translation Capabilities
Linguistic Validation
Language Scientific’s Linguistic Validation group specializes in the translation and adaptation of Clinical Outcome Assessments in all therapeutic areas. We are industry experts in linguistic validation and our process has been designed to ensure that your eCOA is both culturally appropriate and conceptually equivalent in over 215 languages.
- Accurate Patient Insights: Ensure your clinical research captures meaningful, culturally appropriate patient data with expert linguistic validation services.
- Seamless Compliance: Meet global regulatory standards with translations tailored for patient-reported outcomes (PROs) and clinical questionnaires.
- End-to-End Support: From translation to cognitive debriefing, our team ensures every step aligns with your study’s goals.
DICOM Translation
Language Scientific understands the complexity and magnitude of DICOM files and has the tools, processes, technology and expertise to seamlessly redact and translate DICOM files accurately and expeditiously.
- Streamlined Imaging Data: Expertly translate DICOM files to ensure seamless communication and interpretation across global clinical trials.
- Precision in Patient Safety: Maintain data accuracy and regulatory compliance with our specialized medical translation expertise.
- Global Collaboration Ready: Enable effective cross-border collaboration with clear, localized imaging data for every stakeholder.
Endpoint Adjudication
Streamline your endpoint adjudication process with expert translation services tailored for global clinical trials. Our specialized solutions ensure every document and communication is clear, accurate, and compliant across all regions.
- Clarity for Adjudication Panels: Deliver precise translations of clinical data to support informed decision-making during endpoint reviews.
- Regulatory Confidence: Ensure compliance with international standards for endpoint adjudication documentation.
- Tailored Expertise: Work with industry specialists who understand the nuances of adjudication processes and medical terminology.
Patient Data Translation
Unlock the full potential of your patient data with expert translation services designed for global healthcare and research. Our solutions ensure your data remains accurate, compliant, and actionable across borders.
- Data Integrity Across Languages: Preserve the accuracy and clarity of patient data with expert translations for healthcare and clinical use.
- Global Compliance Made Easy: Meet international regulatory requirements with translations tailored to your specific data formats and needs.
- Specialized Expertise: Leverage our deep knowledge in life sciences to ensure your patient data supports effective decision-making worldwide.
The Language Scientific Difference
Medical materials translated by doctors, edited by linguists
No PM fees or hidden fees, complete pricing transparency
99.7% of projects completed by promised deadline
Linguists are tested and accredited by language pair and subject matter expertise
Project Manager response time < 2 hours
Clinical Research Translation
Language Scientific has been providing medical and clinical research translation services to Clinical Research Organizations (CRO) for over 20 years. Our customers in the clinical research industry include Quintiles, PharmaNet, Bioclinica, and PRA International. We translate a wide variety of medical documents from Protocols and Pharmacological Studies to Informed Consent Forms, Patient Questionnaires and Interactive Voice Response (IVRS) prompts.
Sample Clinical Documents We Translate
- Adverse Event Source Document
- Case Report Forms (CRFs)
- Data Sheets
- Development Safety Update Reports (DSURs)
- Dossiers
- Drug Registration Documentation
- Endpoint Adjudication Documents
- Informed Consent Forms
- Insert Leaflets
- Instructions For Use (IFUs)
- Marketing Collateral
- Master Batch Records
- Package Inserts and Labels
- Patient Diaries
- Patient Recruitment Materials
- Patient Reported Outcome Measures (PROMs)
- Patient Source Documents, Admission and Discharge, Labs
- Pharmacological Studies
- Pharmacovigilance and Postmarketing Surveillance
- Product Labels
- QoL Scales
- Regulatory Documents
- Scientific Papers
- Site Operation Manuals
- Study Protocols
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
Medically Precise and Culturally Sensitive
CROs are conducting clinical trials worldwide on behalf of pharmaceutical companies. While this increases the patient pool, and the opportunity to get data from diverse ethnic backgrounds at a reduced cost, there is an accentuated need for accuracy in communication. This pertains not only to the word-for-word translations, but to the concepts of the diseases, side-effects and outcomes being discussed.
A large portion of the communication in the clinical trial process takes place between clinicians and patients. Depending on the study site and the level of literacy of the patients, the patient-facing materials must be translated to match their reading levels, and the cultural component is equally important. For instance, in a recent questionnaire, a patient in rural India was asked,
Has a partner become pregnant since your last study visit?
Clients we Serve
Our clients in this industry range from Fortune 100 multinationals, such as Merck, Novartis, Stryker Medical Devices Technology and Pfizer, to small and mid-size rapidly globalizing technology and biopharmaceutical companies, such as Amgen, Mettler-Toledo, Emergo Group and Tektronix.
Linguistic Validation and Cross-Cultural Adaptation of Clinical Instruments
In addition to clinical research translation, we also provide linguistic validation of Patient Reported Outcomes (PRO)—patient questionnaires used as clinical instruments and scales in the conduct of clinical trials of new drugs. Often CROs must perform back translation and reconciliation, cognitive debriefing and harmonization of the patient responses, so that the data is accurate and consistent across languages. It is crucial to have clean data for the purpose of the actual data analysis. Faulty or inaccurate translations can render the trial inadequate and the drug company loses time and potential revenue.
Our Medical Translators are also Clinicians
Language Scientific is a long-standing partner for Clinical Research Organizations. Our translators are handpicked doctors and clinicians who understand the content based on first hand interaction with patients locally. Our doctor translators are provided with training on the methodology of the clinical trial process and the end client’s requirements. Owing to a strict internal quality control protocol, we are able to provide a Certificate of Translation Accuracy with each project. Language Scientific’s unique methodology that clients depend on delivers consistently clear, accurate translation of high-value information.
Clinical Research Translation FAQ's
What types of documents can you translate for clinical research?
Language Scientific translates a wide range of clinical research materials, including clinical trial protocols, informed consent forms (ICFs), investigator brochures, clinical study reports, case report forms (CRFs), and regulatory submissions.
How do you ensure translations meet regulatory requirements?
Language Scientific’s translations comply with global regulatory standards, including FDA, EMA, and ICH guidelines. We work with certified linguists who specialize in clinical research and understand the nuances of regulatory language.
Do you provide back translation and reconciliation services?
Language Scientific offers back translation and reconciliation services to ensure the accuracy and reliability of critical documents, particularly those submitted to regulatory authorities.
How do you maintain confidentiality in clinical translations?
Language Scientific has strict data protection protocols in place, including secure file transfers and non-disclosure agreements (NDAs) with all team members, to safeguard sensitive clinical data.
Can you handle translations for global clinical trials?
Language Scientific’s expert linguists cover over 215 languages, ensuring precise translations for multinational clinical trials. We understand the cultural and linguistic nuances needed for diverse target audiences.
How quickly can you deliver translations?
Language Scientific works with our clients to deliver high-quality, AI-optimized translations on time. Our streamlined workflows and dedicated project managers ensure quick turnaround times without compromising quality. We work with you to meet strict clinical trial deadlines.
What industries do you specialize in for clinical translations?
Language Scientific specializes in life science translation services, including pharmaceuticals, biotechnology, and medical devices, catering to the specific needs of Clinical Research Organizations (CROs).
Can you translate patient-facing documents for clinical trials?
Language Scientific provides culturally appropriate translations for patient-facing materials such as informed consent forms, patient diaries, and questionnaires, ensuring comprehension and compliance.
How do you ensure linguistic accuracy in clinical translations?
Language Scientific linguists are subject-matter experts with clinical and scientific backgrounds. Every project undergoes rigorous quality assurance processes, including editing and proofreading by senior linguists.
Can you handle rush projects?
Language Scientific offers expedited services for urgent projects while maintaining our commitment to quality and accuracy. We work with you to meet tight clinical trial deadlines.
