Clinical Studies

Our pharmaceutical linguistic team specializes in clinical translation in more than 200 languages.

 

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We are dedicated to industry-standard knowledge and quality. Our translation solutions are intended for document types relating to every stage of product development life cycle. CSOFT works extensively with medical professionals who are dedicated to prevalent therapeutic areas such as:

  • Cardiology
  • Dental
  • Dermatology
  • Gastroenterology
  • Genetic Disease
  • Hematology
  • Hepatology
  • Immunology
  • Infections
  • Neurology
  • Oncology
  • Orthopedics
  • Pediatrics
  • Psychology
  • Rare Diseases
  • Women’s Health

At CSOFT, we’re frequently requested to work on a variety of clinical documentation. Below are some examples of documentation we specialize in:

  • Phase 0 to IV
  • Pharmacology
  • Toxicology
  • Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs)
  • AEs/ARs/SAEs/SARs/SUSARs
  • Adverse Drug Reaction (ADRs)
  • Package Inserts and Labels
  • Insert Leaflets
  • Development Safety Update Reports (DSURs)
  • IEC/IRB Correspondence
  • Clinical Services Agreements
  • Protocol & Protocol Synopses
  • Investigator’s Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Patient-facing Clinical Documents
  • Patient Information Sheet (PIS)
  • Patient Diaries
  • Summary of Product Characteristics (SmPC)
  • Instructions for Use (IFUs)
  • Scientific Papers

CSOFT Life Sciences Guarantees Quality Translations

devices

Scientific Accuracy

Cultural Adaptions

cro

Regulatory Compliance

biotech

Data Security and Confidentiality 

Our Methodology

CSOFT guarantees medical translation methodologies that are compliant with regulatory and legal standards, as required by our pharmaceutical clients.

Our translators are native language subject matter experts with field knowledge translating specific content requirements. CSOFT assigns a team of senior medical translators, editors, and in-country reviewers to perform every translation project, with each individually responsible for translation, proofreading, editing, and independent review. 

Our years of expertise and experience enables our team to customize operating processes on the basis of analysis on specific project requirements. Whenever necessary extra quality control steps of back translation, linguistic validation, and certification are performed.

Contact us for more information

xxx@csoftintl.com
+1 (888)888-8888

Other Medical Translation Services

CONTACT US

info@medl10n.com

+1-415-889-8989

US Headquarters

580 California Street, Suite 1330
San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F
No.1 East Third Ring Road
Beijing, China 100020

Europe Headquarters

Neumannstraße 10
40235 Düsseldorf

 

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North America Headquarters

580 California Street, Suite 1330 San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F No.1 East Third Ring Road BeijingChina 100020

European Headquarters

Neumannstraße 10 D-40235 Düsseldorf, Germany