Translating and Localizing Life Sciences: Clinical Trials and Industry Documents and Terminology
Updated: Jan 30
⬫ What do life science companies do?
⬫ What is a clinical study or a clinical trial?
⬫ What are common documents used in clinical research?
⬫ What kind of documents do pharmaceutical companies use?
Life Science companies and organizations include those operating in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, and biomedical devices, as well as organizations and institutions engaged in various stages of clinical research, development, technology transfer, and commercialization.
Life science companies need a high volume of translation, often in several languages, to launch pharmaceutical products in a new market, provide treatment using the language a patient understands, or export medical devices. This can include technical documentation, marketing content, packaging, and patient information.
High-quality translation is essential for life science companies—it’s always important to ensure translations are accurate or patients can be harmed, or the company may be confronted with legal or financial repercussions. A potential mistake, such as typing the wrong amount of a drug dose, or omitting the word not, can have devastating results. This is why life science companies rely on translations performed by linguists who are subject matter experts, translation companies that follow proven processes to reduce and eliminate errors, and translation technology that enhances the work of both.
Life Science translation generally covers four main areas:
‣ Clinical Studies / Clinical Trials
‣ Pharmaceuticals / Pharma
‣ Medical Devices
‣ Healthcare / Public Health
Before being approved for medical use, any drug, devise, or therapy needs to be clinically tested in a clinical trial or study. The World Health Organization (WHO) defines the clinical study (clinical trial) as any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, and/or identify any adverse reaction to, investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety.
Clinical trials are generally divided into Phases I-IV. The individual phases, based on their purposes as related to the clinical development of pharmaceutical products, can be briefly defined as follows:
Phase I. These are the first trials of a new active ingredient or new formulations in humans, often carried out in healthy volunteers. Their purpose is to make a preliminary evaluation of safety, and an initial pharmacokinetic/pharmacodynamic profile of the active ingredient.
Phase II. The purpose of these therapeutic pilot studies is to determine activity and to assess the short-term safety of the active ingredient in patients suffering from a disease or condition for which it is intended. The trials are performed in a limited number of subjects and are often, at a later stage, of a comparative (e.g., placebo-controlled) design. This phase is also concerned with the determination of appropriate dose ranges/regimens and (if possible) the clarification of dose-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
Phase III. This phase involves trials in large (and possibly varied) patient groups for the purpose of determining the short- and long-term safety-efficacy balance of formulation(s) of the active ingredient, and assessing its overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated, and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to differences in effect, such as age). The trials should preferably be randomized double-blind, but other designs may be acceptable, e.g., long-term safety studies. In general, the conditions under which the trials are conducted should be as close as possible to the normal conditions of use.
Phase IV. In this phase studies are performed after the pharmaceutical product has been marketed. They are based on the product characteristics on which the marketing authorization was granted and normally take the form of post-marketing surveillance, and assessment of therapeutic value or treatment strategies. Although methods may differ, the same scientific and ethical standards should apply to Phase IV studies as are applied in premarketing studies. After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration, or new combinations are normally regarded as trials of new pharmaceutical products.
Common documents associated with clinical research may be roughly defined in terms of their purposes within the full cycle of clinical/pharmaceutical product development:
Clinical Trial Materials & Filings: Subject Recruitment, Clinical Trial Protocols, PISs/ ICFs, IBs, Study Site/ Personnel/ Lab Certifications, Investigator Training, Investigator/Patient Diaries, etc.
Pharmacovigilance & Safety Reporting: IRB/ LEC/ EC/ IEC Communication, Multisite SAEs, SUSARs, etc.
Drug Discovery & Development: Preclinical & Phases I-III, Pharmacological Studies, Export/ Import Approvals, etc.
Compliance & Regulatory: Phase IV/ Sales, MAAs, EMA/ FDA Compliance, Monitoring Logs, SOPs, etc.
Medical Device/Product Marketing & Launch: IWRS/ IVRS Scripts, DSURs, Packaging & Labeling, Brochures, Protocols, CSRs, Scientific Articles, Premarket Approvals, FSNs, SmPCs, IFUs/ DFUs, Mobile & iPad Apps, etc.
Fig. 1. Medical morphology (Hint: Click the arrow icon (>) to see another word)
Clinical Research Organizations (CROs) and pharmaceutical companies conduct scientific trials around the world to study medical conditions and treatments and their effects, side effects and pharmacological interactions. To conduct these trials and market drugs in other countries, pharmaceutical companies need a multilingual approach, making translation a fundamental step throughout a clinical trial.
Common documents that need to be translated:
• Clinical Trial Agreements (CTAs)
• Study Protocols and Amendments
• Regulatory Authorities Documents
• Informed Consent Forms (ICFs)