Clinical Research

Areas

Translations for the clinical research industry

We are experts in translating documents used in clinical studies.

The dynamic development of clinical research in Poland and worldwide has provided us with particularly extensive experience in this field. We support all the actors involved in the research project: from Clinical Research Organisations (CROs) and study sponsors to regulatory authorities, study centres and medical facilities.

Being equipped with a pool of global vendors, hand-picked specialised linguists and proficient knowledge about the current terminology conventions pertaining to clinical studies, we are able to provide high-quality translations of materials from any stage in the investigational product or device life cycle.

Each translation project for documentation related to clinical research is priced individually. This is due both to the varied volume of individual texts and complexity of the subject matter. We take into account the time required for translation and the scope of additional services we are asked to perform, such as editing, revision, back-translation or DTP.

We work with any and all types of materials used in clinical studies, and our coverage of therapeutic areas is vast. We have handled translation and localisation projects from interventional phase I, II, and III studies, non-interventional (observational) studies, as well as phase IV pharmacovigilance studies.

Thanks to our many years of experience in localisation projects related to clinical studies, our clients can be sure that:

We strictly follow quality and safety standards and maintain full confidentiality of the materials we receive
All deliveries are made on time, with observance of SOPs adjusted for the needs of CRO companies
We carefully handpick vendors for individual projects and advise our clients about the best selection of applicable services
Clinical research

Types of documents

As a part of clinical research projects, we handle translations of investigator-facing materials, GP/patient letters, regulatory and legal documents, marketing materials, websites and landing pages, among others.

On a daily basis, we work with:

Informed Consent Forms (ICFs),
Study protocols, Clinical Investigation Plans (CIPs), synopses,
Diaries (including e-diaries), scales, questionnaires, PROs,
Letters (patient letters, referrals, GP letters),
Case Report Forms (CRFs),
Investigator Brochures (IBs),
Regulatory materials (cover letters, EC/IRB opinions, RA requests/approvals),
Source documents (test results, discharge summaries),
Legal and financial documents (clinical trial agreements — CTAs, study budgets, agreements with sites/investigators),
Excerpts from company registers (as sworn/certified translations),
Reports and schedules, audit and monitoring reports,
Marketing materials (posters, flyers, tear-off sheets, social media posts) and websites/landing pages.
Trust
Clinical research

Translations for clinical studies account for over 50% of our total projects

we are trusted by global CROs
Clinical research

Therapeutic areas

Over the years, we have worked on projects related to almost all therapeutic areas in which clinical research is performed. The most frequent of these are:

Oncology (breast, prostate, CNS, blood, GI cancers and malignancies),
Dermatology (psoriasis, autoimmune skin diseases),
Respiratory diseases (asthma),
Allergology,
GI diseases (ulcerative colitis — UC, Crohn’s disease),
CNS diseases (Parkinson’s disease, Alzheimer’s disease, epilepsies — SMEI, LGS),
Metabolic diseases (diabetes, LSDs, Wilson’s disease),
Orphan diseases (Huntington’s chorea),
Viral diseases (infections caused by RSV, CMV, HIV, COVID-19),
Eye diseases (AMD, IOL implantations),
Ear, nose and throat diseases (SSNHL),
Substance dependencies (opiates, alcohol),
Cardiology (artificial heart valves),
Orthopaedics,
Mental diseases (depressive disorders),
Gynaecology (vulvovaginitis, vaginal yeast infections),
Sexuology (erectile disfunction — ED).
Clinical research

Portfolio of services

In order to meet the high quality and safety demanded for translations of materials used in clinical research, we offer the following dedicated services:

written translation
SME review
review and editing
native speaker proofing
back-translation
reconciliation
certified (“sworn”) translation
DTP, layout preservation

Depending on the type of material, as well as the desired target group, we also offer tailor-made service workflows, with our PMs being able to advise on what services and combinations thereof are particularly suited for individual projects. Hence, internal documents can undergo translation and QA only, but highly specialised pharmaceutical materials should, apart from translation alone, go through additional SME review (substantive verification), and articles and publications — through additional proofreading by a native speaker.

Technology
Clinical research

The translation process for clinical trials is supported by advanced technological solutions

state-of-the-art tools allow for a measurable improvement in consistency, homogeneity and uniformity of terminology
Clinical research

Technological solutions

When providing translations used in long-term research programmes, having a truly experienced team is not the only thing that matters: high levels of conformity and homogeneity across documents translated over several years must also be maintained. Thanks to modern tools such as computer-assisted translation (CAT) solutions, glossaries, termbases, translation memories (TMs) and custom NMT solutions, we are able to provide the highest possible conformity of such translated documents.

We also rely on quality assurance tools (QA), which support our linguists, revisers, proofreaders and editors in eliminating any errors and shortcomings at every single stage of the project. We implement, adapt and update quality checks suited to the needs of the clinical trial industry, including the use of preferred/forbidden terminology, correct localisation of addresses, numerals and units of measure, and preservation of document layout.

Further readings