Two Main Styles of Life Science Documents
To launch a pharmaceutical product in a new market, a pharmaceutical company often needs a high volume of documents translated, often in several different languages. Once the product is approved by regulatory authorities, more documents need to be translated so that treatment may be provided using this product.
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.
Any treatment-related documents will need to be presented in two different styles:
Specialist- or Clinician-facing (professional) style
Patient-facing (lay or plain-language) style
Main Areas of Specialization in Translation of Life Science Documents
High-quality translation is essential for life science companies. Any text that accompanies a pharmaceutical product must be professionally presented and accurately translated. Otherwise, patients may not be able to find the information they need, or the information they have found may be inaccurate. This may lead to legal or financial repercussions for the company that owns that product.
A potential error—a typo in the amount of the drug dose, an omitted word not, a misabbreviated b.i.d. (for twice a day), a mistranslated technical term—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
Clinical Research & Documents
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.
Pharmaceutical Products & Documents
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)
• Patient Information Sheet/Patient Information Leaflet (PIS/PIL)
• Case Report Forms/Electronic Case Report Forms (CRF/eCRF)
• Investigator’s Brochures (IBs)
• Summary of Product Characteristics (SmPCs)
• Patient Diaries
• Laboratory Manuals
• Packaging & Labeling
• Clinical Study Reports (CSRs)
• Common Technical Documentation (CTD)
• Adverse Event Reports/Serious Adverse Event Reports (AEs/SAEs)
Healthcare and Public Health & Documents
Linguistically diverse populations need to receive critical health information in a language they can understand. For example, in the United States, there are currently over 21 million people with limited English proficiency. Understanding a medical situation, following treatment instructions, or reading drug labels can be difficult for them.
To avoid dangerous consequences due to miscommunication, it is of utmost importance to translate these documents:
• Informed Consent Forms (ICFs)
• Medical Records
• Patient Questionnaires
• Lab Test Results
• Hospital Release Forms
• Aftercare Patient Instructions
Medical and Surgical Devices & Documents
To market medical devices, companies must conduct clinical trials for some countries, e.g., for the U.S. In the EU, it is not necessary; a self-declaration of conformity is sufficient. Although clinical trials for pharmaceuticals and medical devices differ in the way they are designed and carried out, both need proper terminology in translation for accuracy, understandability, and compliance with the various industry and international standards and regulatory obligations.
Common documents that need to be translated:
• Operating, Maintenance and Installation Manuals
• Development Safety Update Reports (DSURs)
• Instructions for Use (IFUs)
• Regulatory Compliance Documents
• Software Application Interfaces and Documentation
• Package Inserts and Labels
• Patents for Medical and Surgical Devices
• Manufacturing Process Descriptions
• Suspected Unexpected Serious Adverse Reactions (SUSARs)
Patient-Facing vs. Specialist-Facing (Clinician-Facing) Documents
Clinical research and healthcare professionals usually employ two distinctive styles and formats for the documents and materials they work with, depending on the target audience, namely:
1. Patient-facing documents ➔ PISs/ ICFs, Non-Disclosure/ Confidentiality Forms, Patient Questionnaires/ Diaries, BSW (Benefit, Satisfaction, and Willingness to Continue) Surveys, Patient’s Global Impression of Change, Patient-Weighted Quality of Life, Vaccination Report Cards, Dosing Instructions, Patient Symptom Questionnaires, IWRS/ IVRS script prompts for consumer health devices, medical device packaging & labeling, brochures, etc.;
2. Specialist-facing documents âž” Clinical Trial Protocols and amendments, CRFs, IBs, CTAs, Investigator Diaries, IRB/ EC/ EC/ IEC communication, multisite SAEs, SUSARs, Export/Import Approvals, MAA submissions, EMA/ FDA compliance, CSRs, FSNs, SmPCs, IFUs, Safety Package Inserts, Clinical Study Completion Reports, Custom Clearances, Pharmaceutical Patents, MRI/ CT Scan/ Blood Count/ Urine Test Results, patient medical histories, medical case studies, peer review articles/scientific articles, Immunization Books, Discharge Summaries, Lab Ranges, Ultrasounds, referral letters for initial reviews, COAs/ PROs/ ClinROs/ ObsROs, IWRS/ IVRS script prompts for medical devices used by health professionals, etc.
Source: WHO Medicines Regulatory Package. A Collection of Tools for Medicines Regulatory Authorities: Regulatory Support Series No. 014 at: http://infocollections.org/medregpack/interface/files/glossary.pdf
