Life Sciences Translation
Pharmaceutical, clinical trial, medical device and patient information translation.
Our Life Sciences Journey
At Semantics Trans, we have been handling Life Sciences translations for more than 20+ years. The various topics relate to pharmaceutical and informed consent form (ICF) translation, covering patient-facing documents, specialist-facing documents and site-specific questionnaires.
During these years we have handled millions of words in all 11 Indian languages (and Urdu), besides some of the major Asian languages.
11 Indian languages and Urdu
Major Asian languages
Over these years we have developed translation memories (TMs) and glossaries in all of these languages in the field of life sciences.
This field is unusual in the sense that a term which appears easy to understand can have a meaning quite different from its literal sense. For instance, "double-blind" can be badly incorrectly read as "blind in both eyes" or "doubly blinded", whereas its actual meaning is "neither the participants nor the researcher knows which individuals are receiving the active treatment (the new drug itself) and which are receiving a placebo".
Similarly, there are many other terms that can be thoroughly confusing unless you are familiar with ICF terminology. Another example is "baseline". It can be misread as "the line that marks each end of the court in games such as tennis", while its meaning in pharmaceutical research is "an initial measurement, test result or observation of a person's health status, used as a standard point of comparison for future evaluations".
Terms that are easily misread
More terms of this kind are shown below, each with its literal reading and its meaning in clinical use.
arm
Can be misread as
The limb
In clinical use
A planned pathway through the study to which participants are assigned, describing the treatments, controls or observations they receive.
trial
Can be misread as
A court case; an ordeal
In clinical use
An interventional investigation in human participants, intended to discover or verify the effects of an investigational product.
serious vs severe
Can be misread as
Synonyms
In clinical use
Severe describes intensity (mild, moderate, severe). Serious is based on outcome: death, a life-threatening event, hospitalisation, lasting disability or a birth defect. A severe headache can be of minor medical significance.
positive; negative (test result)
Can be misread as
Good news; bad news
In clinical use
Positive: the test shows that the person has the disease, condition or marker tested for. Negative: it is not present.
progression; progressed
Can be misread as
Progress, improvement
In clinical use
The course of a disease as it becomes worse or spreads.
culture
Can be misread as
Customs and traditions
In clinical use
Growing micro-organisms or cells in the laboratory.
What we cover
The kinds of life sciences content we handle, each one backed by assignments we have delivered.
Clinical trials and informed consent
Consent forms, protocols and participant-facing material for clinical studies, from recruitment through to the diaries participants keep at home.
- Informed consent forms
- Paediatric assent forms
- Protocols
- Participant diaries and ID cards
- Recruitment material
Questionnaires and rating scales
Quality-of-life questionnaires, sleep evaluation scales and clinician-administered cognitive tests, where response options and scale anchors have to mean the same thing in every language.
- Patient-completed questionnaires
- Clinician-administered tests
- Site-specific questionnaires
Medical devices
Instructions for use for implants and stimulators, and consent material for device registries. We are certified to ISO 13485:2016, the quality standard for the medical device supply chain.
- Instructions for use (IFU)
- Device registry consent forms
- Technical specifications
Patient information and public health
Procedure leaflets, community health information and medication guides, written for readers with no medical training and often read at a stressful moment.
- Patient information leaflets
- Community health information
- Medication guides
- Diet and self-care guides
Medical records and health insurance
Medical histories, clinical examination findings, insurance claims and health coverage notices, where the reader is an assessor or a policyholder.
- Medical records
- Insurance claims
- Coverage and eligibility notices
Ayurveda and traditional medicine
Ayurvedic texts, product documentation and research papers, where Sanskrit-origin terms have no direct equivalent in Western medicine.
- Formulation documentation
- Product labelling
- Research papers
Excerpts from our most technical assignments
Here are a few excerpts from the most technical medical, pharmaceutical and ICF assignments we have handled between 2005 and 2023 (18 years).
Showing 59 of 59 excerpts
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with Optional 26-Week Active Comparator-Controlled Extension Periods [Rivoglitazone and pioglitazone are the "study drugs" for this extension study. Rivoglitazone is an investigational drug. An investigational drug is a drug that is still being studied and has not been approved by the United States Food and Drug Administration (FDA) and the Drug Controller General of India [DCG(I)] or by other regulatory agencies around the world. The use of rivoglitazone is permitted for research purposes only. Pioglitazone is approved by the US FDA and other regulatory agencies for the treatment of type 2 diabetes under the commercial name "[withheld]". It is used in this extension study for comparison purposes.]
consists of 70 questions which assess 11 dimensions of health-related quality of life including general health perception, social relationships, emotional distress, energy/fatigue, sleep, cognitive functioning, physical activities, coping, future, impact of symptoms and side effects, and treatment. In addition, one item assesses resources (financial difficulties), one item assesses satisfaction with care and one item the level of worry caused by the difficulties of having a child.
these questionnaires ask about how HIV and its treatment have affected a patient's health and life over a certain period.
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of [withheld]-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension.
A random, Double Blind, Placebo and Active Comparator Controlled parallel group research of the Revoclytoson safety and benefits in Monotherapy treatment type 2 of diabetes mellitus.
A randomized, double-blinded, placebo and active comparator-controlled, parallel group study to determine the efficacy and safety of Rivoglitazone as monotherapy treatment of type 2 Diabetes Mellitus with active comparator controlled optional 26-week extension period.
The triggers for your asthma symptoms are all around you—pets, pollen, pollution, and even people. What are you doing to stay in control? If you continue to experience attacks even though you take your medication as directed, you may want to consider volunteering for a clinical research study.
Patient has used medications with known activities as strong inhibitors or inducers of P-450 metabolism (e.g., phenobarbital, phenytoin, rifampin, trimethoprim/sulfamethoxazole, and ketoconazole [or other azoles]), 2 weeks prior to Visit 1, or plans to take such medications during the study. Patient has used any medication with a narrow therapeutic index (e.g., Warfarin, Coumadin, Dicoumarol, digoxin, Digitoxin) within 2 weeks prior to Visit 1 or plans to take such medications during the study.
Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.
One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.
As a participant in the CV185030 clinical research trial, you have been assigned to 1 of 2 study treatment groups and you are currently taking study medication, either an investigational medication or warfarin. This study is being conducted "double-blind," which means neither you nor your study doctor will know if you are taking the investigational medication or warfarin, except in a medical emergency.
In addition to your blinded study medication (investigational medication or warfarin), you are also taking a placebo (inactive pill).
Since your study medication may include warfarin, you must follow the medication precautions and dietary rules as if you are taking warfarin. This Warfarin Information Guide is a helpful source to assist you during your participation in this study.
Study with an ERA in Pulmonary arterial Hypertension to Improve clinical outcome (Open Label) - Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of [withheld]-064992 in patients with symptomatic pulmonary arterial hypertension
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with an optional 26-Week Active Comparator-Controlled Extension Periods.
[withheld] Pharmaceuticals, Inc., "A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration" - You are being asked to take part in this research study because you have neovascular Age-Related Macular Degeneration (AMD). This study involves the use of an investigational drug called VEGF Trap-Eye. VEGF Trap-Eye has not been approved by the US Food and Drug Administration (FDA). Its use in this study is experimental. This study also involves the use of an FDA-approved drug called [withheld]® (ranibizumab). [withheld] Pharmaceuticals, Inc. sponsors this research study.
Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - You are being asked to join this research study because you have non-small cell lung cancer and your disease has progressed since receiving erlotinib ([withheld]®) or gefitinib ([withheld]®). Taking part in a research study is your choice. Important information about this research study is explained below. Please read this information carefully and ask as many questions as you like before you decide to join the study. [withheld] Pharmaceuticals, Inc. (BIPI) is the sponsor of this research study. BIBW 2992 is an investigational (experimental) drug which means that it has not been approved by the Food and Drug Administration (FDA) and it is not available to people who are not in research studies like this one. In this study, BIBW 2992 50 mg, will be compared to placebo. A placebo is an inactive substance. For this study the placebo will be an inactive pill and will look just like the BIBW 2992 pill.
Specially formulated to help prevent certain chronic illnesses; Contains lycopene (2 mg), lutein (2 mg), vitamin C (250 mg), vitamin D (800 IU), B12 (100 mcg) and selenium (70 mcg); Two tablets per day; Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables; Centrum Select® - Specially formulated for adults over 50. Helps maintain cardiovascular and eye health; Contains lycopene (600 mcg), lutein (500 mcg), vitamin D (600 IU), vitamin K (25 mcg), extra vitamin E and calcium; Lower level of iron; Also available in chewables.
Key Beneficial Nutrients: B Vitamins, Vitamin C, Vitamin E and Niacinamide; BREAST HEALTH - Key Beneficial Nutrients: Vitamin D, Vitamin B6, Vitamin B12 and Folic Acid; COLON HEALTH - Key Beneficial Nutrients: Vitamin D and Folic Acid
Food Groups Tips Healthy choices Limit or avoid Vegetables & Fruit
Vary your choices by selecting fruit and vegetables with various vibrant colours
Keep the skin on your fruit and vegetables as it is an important source of fibre
Berries, figs, grapefruit, honeydew melon, nectarines, pears, tangerines
Asparagus, broccoli, cabbage, cucumber, eggplant, green and yellow beans, spinach, tomatoes
Avocados and olives – they do contain important nutrients, but they are high in fat and should be limited to avoid weight gain
Those prepared with added fat, sugar or salt
Grain Products
Choose low-fat, whole grain foods as they are high in fibre
Whole grain bread, brown or wild rice, whole wheat pasta, bran based cereals, oatmeal, barley
High-fat choices such as muffins, cookies, croissants
Milk & Alternatives
Choose low-fat where possible
Replace high-fat choices such as ice cream with lower fat ice milk or frozen yogurt
Cottage cheese, skim milk, yogurt, soy milk
Butter and high-fat cheeses with saturated fats
High-fat additions like cream or cheese based sauces
Meat & Alternatives
Choose leaner meat
Choose low-fat cooking methods such as broiling, baking or steaming
Lean meats, fish, eggs, dried beans, lentils, skinless turkey or chicken, tofu
High-fat meats such as bacon and sausage
Original document (not reproduced): A clinician-administered cognitive screening test covering orientation to time and place, word registration, and attention and calculation.
A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus 'Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane - The purpose of this study is to compare the effectiveness of a new drug called Eribulin (also referred to as E7389) with existing, available treatments. The study involves female patients with locally advanced or metastatic breast cancer, whose disease has already progressed after treatment with drugs known as anthracyclines and taxanes. You may have received other treatments in addition to these. For this type of advanced cancer most of the available treatments have only limited activity so it is important to find new drugs.
Facing an asthma attack can be frightening and dangerous until you regain control. If you continue to experience attacks even though you take your medication, you may want to consider volunteering for a clinical research study. This study is evaluating an investigational drug to see if it can help control your asthma symptoms when taken with your regular medication. As a qualified participant, you will receive all study-related care and study medication at no cost, and you may be compensated for time and travel. There are important things you should know about potential benefits and risks that the study doctor will explain to you.
A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy - The study doctor and Wyeth, the study sponsor, are studying sorafenib (Nexavar®) and temsirolimus (Torisel®). Both Nexavar® and Torisel® are drugs approved by the Food and Drug Administration (FDA) for treatment of advanced renal cell carcinoma (kidney cancer). You are being asked to take part in this study because you have been diagnosed with advanced kidney cancer, also known as metastatic renal cell carcinoma, and your disease condition got worse while you were being treated with Sutent®. The purpose of this study is to learn whether Torisel® and Nexavar® are safe and useful in treating advanced kidney cancer when given after treatment with Sutent® fails.
Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus with An Optional 26-Week Active Comparator-Controlled Extension Periods. Purpose - Rivoglitazone is an investigational drug. An investigational drug is a drug that is still being studied. It also means that it has not yet been approved by the U. S. Food and Drug Administration (FDA). The FDA allows rivoglitazone to be used only in research.
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects with Class III or IV Lupus Nephritis in Combination with Mycophenolate Mofetil Therapy - If you say Yes to being in this study you will have to do certain things. You will need to take MMF and corticosteroids along with study drug. The study drug can either be the active drug or one that looks like the study drug but isn't active, called a placebo. The study drug will be given to you by injection under your skin, twice a week at first, then once a week for the rest of the study. These injections will hurt. You will have to come back to see the study doctor about 19 times in the next year and a half. We will ask you to tell us how you feel, what medicines you are taking, and if you are having any problems.
Otsuka Maryland Research Institute, Inc., "An Open-Label Rollover Study for Subjects with Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241" - The purpose of this study is to continue to provide ARIPIPRAZOLE therapy to adolescents or adults with schizophrenia completing the 31-03-241 study.
A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus 'Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane.
STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMY - You are being asked to participate in a patient registry, sponsored by [withheld], a [withheld] company, because your doctor has determined that you should receive a procedure called carotid stent supported angioplasty, and will use the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW) to perform this procedure. Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the neck, heart and legs. A stent is a metallic device that behaves like a spring to keep the artery open. The devices that will be utilized are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW). The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella intended to capture debris that might be released during the procedure and help reduce the chance of stroke. Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE® stents that are approved for use by the FDA in the future may also be used.
Original document (not reproduced): The Leeds Sleep Evaluation Questionnaire, answered on visual-analogue lines.
Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners.
Asthma is a condition that affects the airways of the lungs leading them to become inflamed and swollen. It can affect adults and children of all ages. Approximately half of all individuals with asthma first experience symptoms before the age of ten.
The condition is called non-allergic asthma when there is no obvious allergic cause. Asthma is more commonly experienced when an individual comes into contact with an allergen that he/she is sensitive to; this is called allergic asthma. Allergic asthma may account for up to nine out of ten of all asthma cases.
What are the symptoms of asthma? - The following symptoms may be experienced with asthma: Difficulty breathing, Audible wheezing, A dry irritating cough, Chest tightness
[withheld] Research Institute, Inc., "an open-label rollover study for subjects suffering from schizophrenia and have completed the ABILIFY® (Aripiprazole) clinical study 31-03-241" - The purpose of this study is to continue to provide Aripiprazole therapy to teenagers or adults suffering from schizophrenia and have completed the 31-03-241 study.
A double-blind, dose-ranging, placebo-controlled, randomized study to evaluate the safety and efficacy of INCB013739 plus metformin compared to metformin alone on glycemic control in type 2 diabetic subjects not adequately controlled by metformin monotherapy - This will be a double-blind, placebo controlled, randomized Phase 2 study to evaluate the efficacy, safety, and tolerability of INCB013739 when administered as an add-on to stable metformin therapy in patients with type 2 diabetes who are not adequately controlled by metformin alone. The Objectives of this study are to determine the effect of 12 weeks of treatment with INCB013739 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects
Original document (not reproduced): An emergency trial identification card with the patient name, study number and a note of the possible blinded treatments in a double-blind lung cancer study.
This study is a randomized, double-blind, placebo-controlled Phase 3 study to investigate the prevention of relapse in DLBCL using enzastaurin daily. This means participants will be assigned by chance to one of two treatment groups. One group will receive the investigational drug, and the other will receive placebo. Neither the medical personnel nor the patients will know who is receiving enzastaurin and who is receiving placebo. Twice as many patients will receive enzastaurin as placebo. Patients must enter the research study no later than 90 days either from the first day of the last cycle of R-CHOP therapy or from the last day of radiation therapy that was received as first-line treatment for DLBCL. Both enzastaurin and placebo are tablets and will be taken orally each day within 30 minutes of finishing a meal.
Original document (not reproduced): A patient visit card giving the date of the next study visit, instructions for the three days before it, and boxes for recording the date and time of each dose of study medication.
Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - You are being asked to take part in a research study involving the collection of tumor material from your biopsy and a sample of your blood for genetic research of your tissue. The genetic testing in this research is looking for EGFR mutation. EGF is a receptor that can be found on a cancer cell. When EGF is stimulated, the growth of cancer cells is accelerated. The main purpose of this study is to do laboratory tests on your tissue and blood sample to find out how the study drug may work, and to better understand why the study drug may work well in some patients but not others.
Original document (not reproduced): Three clinical fact lists on blast injuries, covering lung injury, abdominal injury and ear injury.
Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - The purpose of this research study is to find out if the experimental drug, BIBW 2992, works better than placebo (inactive substance) in patients with advanced non-small cell lung cancer with progression of the cancer after being treated with erlotinib (Tarceva®) or gefitinib (IRESSA®). In addition to the study drug (BIBW 2992 or placebo) all subjects will be treated with best supportive care (BSC). Best Supportive Care is defined as psychological and nutritional support, the use of medicines for pain, infection, nausea or vomiting when needed, oxygen, blood transfusions and other treatments to manage your symptoms.
The purpose of this research study is to find new ways to identify and treat diseases. You are being asked to be in this study because of the tissue you may have removed during your surgery. Pathology will process these tissues to obtain a diagnosis. Any excess tissue not needed for diagnosis may be used for this study. This study does not require you to have any other surgery or to have any extra tissue removed. The tissue samples and medical data will be processed for Asterand, a for-profit biomedical research company. You may also be asked to provide blood samples for this study. Tissues, blood samples, and medical data will be sent to researchers at non-profit research centers and commercial companies. The samples and data may be used right away or may be stored indefinitely for future research.
is a mood disorder that involves repeated episodes of mania and depression. A manic episode is a state during which your mood becomes exaggerated and you may experience increased energy and a decreased need to sleep. Although there's currently no cure for bipolar disorder, research is under way to find possible treatments to help control the manic episodes associated with the disease.
Please take your medication and complete your diary every morning upon waking. Complete your diary with the symptoms you had the day and night before. Complete one colored section per day. In the upper-right hand corner on the first fold out page of the diary please enter the date of the first time you took your medication. This date should match your first diary entry date. Complete the diary every day even if you did not have heartburn on the previous day.
A randomised, multi-centre, placebo-controlled study to assess the efficacy and safety of Eltrombopag in thrombocytopenic subjects with Hepatitis C (HCV) infection who are otherwise eligible to begin antiviral treatment (Peginterferon alfa-2b plus Ribavirin) – The [withheld] Department at this hospital is carrying out a clinical research study, sponsored by [withheld]. The aim of this study is to assess the safety and efficacy of Eltrombopag when used in patients who, like you, are infected with the hepatitis C virus and have a decreased platelet count (thrombocytopenia). For this reason, they cannot be given treatment for their infection with the hepatitis C virus. Platelets are blood cells that help to stop bleeding caused by a wound, such as a cut to the skin. Eltrombopag is a new drug that increases the number of platelets in the blood. You are being invited to participate in this study. It has been calculated that 750 patients will take part in this study. The study has been approved by the Research Ethics Committee of the [withheld] Hospital and by the Ministry of Health, and will be carried out in accordance with the ethical guidelines of the Helsinki Declaration and the requirements stipulated by the Royal Decree 223/2004.
Original document (not reproduced): An illustrated eight-step patient instruction sheet for collecting stool samples at home and returning them to the laboratory.
Warfarin Sodium (COUMADIN®), also known as warfarin, is an approved drug that is used to prevent blood clots from forming or growing larger in your blood and blood vessels. Warfarin is in a class of medications called anticoagulants or blood thinners. One of the conditions for which warfarin is prescribed is to help prevent and treat blood clots associated with an irregular heartbeat called atrial fibrillation. Warfarin works by blocking the formation of clotting factors in the liver that are dependent on vitamin K.
As a participant in the CV185030 clinical research trial, you have been assigned to 1 of 2 study treatment groups and you are currently taking study medication, either an investigational medication or warfarin. This study is being conducted "double-blind," which means neither you nor your study doctor will know if you are taking the investigational medication or warfarin, except in a medical emergency.
In addition to your blinded study medication (investigational medication or warfarin), you are also taking a placebo (inactive pill).
Original document (not reproduced): The cover page of a patient's diary, with fields for the investigator, site, subject and medication numbers and the visit dates.
Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥18 years old) with Acute Rhinopharyngitis (ARP)
Original document (not reproduced): A clinical trial medication label giving the tablet contents, dosage, storage instructions and "For clinical trial use only".
Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥ 18 years old) with acute rhinopharyngitis: The acute inflammation of nose and throat regions (acute rhinopharyngitis) with symptoms such as nasal congestion, runny nose, sore throat and headache, is one of the most common illnesses worldwide. Though mostly caused by viruses, these infections are often treated unnecessarily with antibiotics in the beginning stages. Therefore, alternative therapy concepts, e.g. therapy with herbals are desired both by doctors and patients. EPs® 7630 is an herbal extract prepared from the roots of Pelargonium sidoides (also known as "South African Geranium") in formulation of either solution or film-coated tablet. No animal substance is used in EPs® 7630 preparation and manufacturing process. Purpose of this clinical trial is to determine whether EPs® 7630 film-coated tablets possess a beneficial effect in the therapy of acute rhinopharyngitis (inflammation of nose and throat), as well as the safety and tolerability. A number of previous studies conducted in both adults and children (aged from one year old) have shown good safety and tolerability profile of EPs® 7630 in all age groups.
I authorize the above-named source to release or disclose the following information: Any medical records or other information regarding my treatment, hospitalization, and/or outpatient care for my condition(s), including psychological or psychiatric condition(s), alcohol and/or drug abuse, or any HIV-related information. (In accordance with Federal confidentiality rules (42 CFR Part 2), State Mental Health Procedures Act and Act 148)
Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib: You are being asked to take part in a research study involving the collection of tumor material from your biopsy and a sample of your blood for genetic research of your tissue. The genetic testing in this research is looking for EGFR mutation. EGF is a receptor that can be found on a cancer cell. When EGF is stimulated, the growth of cancer cells is accelerated. The main purpose of this study is to do laboratory tests on your tissue and blood sample to find out how the study drug may work, and to better understand why the study drug may work well in some patients but not others.
Original document (not reproduced): A statement of what research participants should be told before agreeing to take part in a study, and of their right to leave it at any time.
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis: The purpose of this study is to find out if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to find out if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for your disease to get worse. The safety of BG00012, how well you tolerate it, and the effect it may have on tests and evaluations used to assess MS are also goals of this study.
A Randomized, Double-Blind, Placebo-Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation: This study will involve an experimental drug called ART-123 that is used for the treatment of subjects like you who have DIC and sepsis. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration (FDA) or by the national health authority in your country. (Note: ART-123 was recently approved in Japan for treatment of DIC.) ART-123 is a protein called thrombomodulin that stops blood from clotting and prevents the loss of platelets from the blood.
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder: You are being asked to take part in a research study sponsored by [withheld] Research & Development Centre (Europe) Ltd. The purpose of this study is to assess the effectiveness, safety, and tolerability of 3 different doses of the study drug, Lu AA21004 (1 mg, 5 mg and 10 mg) compared with placebo (a non-active drug/a "dummy" drug). The placebo will be a look-alike drug that has no active drug in it.
When you're sick, you want a medicine that works quickly and effectively to make you feel better and help fix whatever is wrong. To make sure that's just what you get, researchers are working hard to understand how to make medicines that can help the greatest number of people possible. Because even though our bodies are 99 percent the same, we have small differences that make us individuals – our genes – and those genes affect how medicines work inside us. The material inside our genes, DNA, is as unique as you are. Right now, researchers are studying DNA from people around the world to help them develop better medicines. Right now, they're asking people just like you to help.
As part of a [withheld] sponsored clinical trial, you have the opportunity to provide a sample of your DNA to help in this important research program. It's as simple as collecting an extra tube of blood. From that blood, scientists will collect the DNA and it will become part of a DNA bank that they will use for research.
Original document (not reproduced): The introduction to a patient leaflet about the information held in health records and how it will be accessed under the NHS Care Records Service.
A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation – Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE – AF): You are being asked to participate in a clinical study for a condition called Atrial Fibrillation. Atrial fibrillation (AF) is an abnormal heart rhythm which results in irregular heart beats. AF is the most common type of arrhythmia (a change in the rhythm of your heartbeat) in adults and becomes more common with increased age. Patients with AF are at increased risks for thromboembolic (blood clots) disease. Sometimes clots can break away and travel through the major blood vessels and the chamber of the heart eventually blocking smaller vessels throughout the body. The condition that occurs when a blood clot blocks smaller blood vessels in the brain is known as a stroke.
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn's Disease: You are being asked to participate in this research study because you have been diagnosed with moderate to severe Crohn's Disease (CD) and have not responded well to at least one other therapy. In this study, an investigational drug called MLN0002 will be tested to see if it is effective in treating CD. MLN0002 is a monoclonal antibody and works by attaching itself to a particular kind of white blood cell and reducing inflammation. The term "monoclonal" refers to the fact that it is produced in a laboratory. MLN0002 is a new type of investigational drug that is being developed by scientists at Millennium, the sponsor of this study. The term "investigational" means that the drug is still being tested and is not approved for sale in (specify appropriate country/regulatory body).
The main purpose of this study is to find out whether treatment with MLN0002 is effective and safe in treating your CD.
Original document (not reproduced): A consumer health leaflet, "Top 5 Things You Need to Know about Trans Fat", in question-and-answer form.
Review of Tasigna dosing regimens and patient compliance in ENACT patients with imatinib-resistant / intolerant Ph+ CML CP or AP when transitioned from Glivec (imatinib) to Tasigna (nilotinib)
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis: We are inviting you to participate in an optional study to collect blood for DNA research. Segments of the DNA called genes are responsible for passing particular traits such as eye color from parents to children. Just as some genes control eye and hair color, others affect the chances that we will get certain diseases or the way that our bodies respond to medicines. DNA analysis may predict how long a medicine stays in your body, whether you are likely to benefit from a drug, or whether you are likely to have a side effect from a particular drug. Your participation in this research is limited to only the requirement that the study doctor or personnel collect a sample of your blood for DNA one time. You do not need to participate in this optional study to participate in the main study, C13006. If you decide not to participate in this optional study and have a blood sample collected and stored for research, this will have no effect on your participation in Study C13006.
Recent life sciences projects
The 6 most recent of 13 healthcare and pharmaceutical projects on our current project list.
Confidential (Pharmaceutical)
CompletedClinical Trial Participant Materials - Informed Consent Form for a study in newly diagnosed multiple myeloma (maintenance therapy…
Healthcare & Pharmaceutical
per language
Confidential (Healthcare)
CompletedPatient Information Leaflets - Termination of Pregnancy, Cataract Surgery (phacoemulsification) with Monofocal Intraocular Lens…
Healthcare & Medical
Confidential (Insurance)
CompletedMedical Insurance Reimbursement Claim - medical history, clinical examination findings and cause-of-death documentation
Healthcare & Medical
Confidential (Health Insurance - US)
CompletedUS Health Insurance Notices - Health Insurance Marketplace coverage options and eligibility, enrolment periods, employer-offered…
Healthcare & Medical
Confidential (Healthcare)
CompletedPatient Information Leaflets - Surgical & Clinical Procedures: Spinal Anaesthetic, Mastectomy, Pacemaker Insertion, Implantable…
Healthcare & Medical
per language
National Institute of Health (NIH)
CompletedCommunity Health Information - Diet & Diabetes, Asthma Management, Healthy Aging & Home Safety: "DASH-Style Diet Helps Control…
Healthcare & Medical
per language
Case studies
Life sciences projects, with the problems and the corrections described in full.
English → 9 Indian Languages: ICF Translation for a Stem Cell Transplantation Clinical Trial
A 22,000-word Informed Consent Form for a clinical trial related to stem cell transplantation, translated simultaneously into 9 Indian languages - navigating the fine line between clinical precision and participant comprehension across nine distinct scripts, with no established pharmaceutical vocabulary database available for several of the target languages.
Consistent, Clinically Accurate at Scale: English to Punjabi Patient Information Translation
A large set of pre- and post-operative patient information documents translated from English into Punjabi - and the quality framework built to catch what a fluent-sounding translation can still miss: an inconsistent term, a transposed risk statistic, or a quietly dropped safety clause.
Inside a Regulated Translation Review: English to Kazakh for a Medical Device Manufacturer
A regulated Instructions for Use translation for a medical device manufacturer, from English into Kazakh - the structured, documented QA review process that catches terminology inconsistencies and mistranslations before a document reaches a hospital shelf, with real before-and-after correction examples.
Standards we are certified to
A quality management standard written for organisations in the medical device supply chain, including those providing services to device manufacturers.
The standard written specifically for translation companies. It sets minimum qualifications for translators and requires that a second qualified linguist revises every translation.
The international standard for protecting information. It covers who can access client files, how they are stored and transmitted, and what happens if something goes wrong.
How the work is protected
- ›Pharmaceutical and ICF work runs at our Full Human TEP tier: translation, editing and proofreading by three separate native-language professionals, with no AI at any stage.
- ›One glossary is agreed before translation begins and applied across every language team on a study.
- ›Figures are verified as a separate check: dosages, risk percentages and measurements, digit by digit.
Reference library
Glossaries and guides we have published from this work.
From our blog
India as a Clinical Trial Translation Hub: Language Diversity as an Asset, Not a Barrier
India's 22 languages are usually seen as a translation burden. Here's why that framing is backwards - with 2026 regulatory data, real numbers, and a practical sponsor framework.
26 August 2026Plain Language Summaries for Clinical Trials: A Guide
EU CTR now requires a plain language summary for every clinical trial. See the deadlines, reading-level rules, and translation requirements sponsors must meet.
27 July 2026Have a life sciences project?
Tell us the document type, the languages and the deadline. We will confirm the approach and who would handle it.
Translator with a life sciences background? Apply through the same form and list it under your specialisations.