MEDICAL TRANSLATIONS


Translations of product information, production instructions, protocols for clinical studies, patient information, patient consent forms, medical literature etc.

JANSSEN-CILAG Italy
WORKING INSTRUCTIONS
MEDICAL DEVICES AND DIAGNOSTICS (CYPHER™ Sirolimus-eluting Stent)
Use and cleaning of the imaging systems, the nitrogen line decompression chamber, the imaging systems, the ultrasonic cleaner. Checks performed during the production: pull test.
Check of the calibration of the critical instruments of the cleaning ovens. Calibration of the instruments of the pac heat sealer MEDVAC GA18. Air ionizers maintenance. Deviation of processes during production.
ENVIRONMENT MANAGEMENT SYSTEM
Waste goods management. Management of chemicals.
Johnson & Johnson – Janssen Pharmaceutica
Clinical protocol regarding the use of the antiepileptic topiramate (Topmax).
UCB Pharma Belgium
Some 30 technical documents concerning the use of Somatostatine-ucb® for the treatment of the early treatment of upper gastrointestinal (UGI) bleeding, fistulae and pancreatic surgery etc. (XPERT trial).
Technical translations regarding the use of Xyzal® (generic name levocetirizine, a new H1-antihistaminic for the treatment of persistent allergic rhinitis).
Kyphon
Medical devices for minimally invasive spine surgery using its proprietary balloon technology (Balloon Kyphoplasty).
Patient information sheet & informed consent form.
Merck KGaA
Patient information sheet regarding the use of cilengitide and temozomide with supporting radiotherapy on patients with a recently diagnosed glioblastome.
Baxter
Open-label, follow up, phase IV clinical study to evaluate the immogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml in subjects previously vaccinated using a rapid immunization schedule.
Bayer Biological Products
Newsletters for haemophilia patients.
AVS (Advanced Veterinary Systems) - Foran Equine Products, Ireland
Product information on veterinarian products (nutritional supplements, care products etc.).
Fisher Clinical Services
Translation of a series of articles on the subject of the use of bufexamac in unguents and the allergologic aspects (contact dermatitis) connected to it.
Avodart
Translation of an article on dutasteride (Avodart®), a new 5-α reductase-inhibitor in the treatment of benigne hypertrophy of the prostate.
GlaxoSmithKline
Texts regarding the procedures that has to be observed during clinical experiments/trials.
Documents on the topic of the Belgian law of 7 May 2004 on the subject of experiments on human persons.
Tibotec Pharmaceuticals Ltd (subsidiary company of Johnson & Johnson)
Protocol for an open-label safety study of TMC114 in combination with low dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly experienced HIV-1 infected patients with limited or no treatment options.
Neurochem Inc.
A Phase III Study of the Efficacy and Safety of AlzhemedTM as add-on therapy in mild to moderate Alzheimer’s disease patients.
Hoffmann-La Roche
Patient information and informed consent for a randomised, double-blind phase III study to evaluate the efficacy and safety of bevacizumab in combination with interferon alfa-2a (Roferon) versus interferon alfa-2a and placebo as first line treatment administered to nephrectomised patients with metastatic clear cell renal cell carcinoma.
TAD Pharma
PIL and SPC for the use of Simvacux (simvastatine).
STEIGERWALD
PIL for the use of Phytodolor, an herbal antirheumatic used in painful inflammatory or degenerative rheumatic diseases.
INTERNATIONAL BREAST CANCER STUDY GROUP (Switzerland)
Study of Letrozole Extension, a phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer.
ulti med Products
Expert report on a contested patent for a test device, written by prof. dr. Frank F. Bier, Fraumhofer-Institut für Biomedische Technik, Potsdam.
GREENFACTS (http://www.greenfacts.org)
Scientific consensus reports (psychoactive drugs, capture and storage of CO2, agriculture and development, climate change), published under the authority of the GreenFacts Scientific Board composed of independent experts.