about-banner

Clinical Study Protocol Translation

Translation services are becoming an indispensable component along with the increasing demand for conducting multi-country clinical trials. The clinical trial follows a carefully controlled protocol, a study plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical Study Protocols (CSPs) assist communication among all the people working in the trial and can be regarded as a "written agreement between the investigator, the subject, and the scientific community." Each protocol describes the objectives, design, methods, statistical aspects and organization of a trial. Well-written CSPs are essential to the conduct of successful clinical studies.

Protocols are conventional documents with a relatively patterned structure. Standardized elements in a clinical protocol (Spilker and Bert, 1984):
A. Protocol format
  • Title page
  • Table of contents
  • List of abbreviations
  • References and appendices
B. Protocol content
  • Patient enrolment and duration of the study
  • Location of study site
  • Factors to control within or outside the study environment
  • Shipping of drugs to and from the study site
  • Obtaining, handling, and shipping biological samples
  • Defining the time of patient entry and completion
  • Eliciting and categorizing adverse reactions
  • Missed appointments
  • Patient lost to follow-up
  • Patient discontinuation
  • Early study discontinuation
  • Medical emergencies
C. Administrative elements
  • Administrative responsibilities of the investigator
  • Informed consent
  • Institutional approval
  • Confidentiality of data
  • Collection and processing of data
  • Publishing of data
  • Monitoring of the study
  • Protocol amendments
Features of Our Services

Performed by professional translators with experience in the most fields of medicine.
Quality assurance and linguistic validation of translated documents.
Prepare documentation that accompanies CSPs, such as IBs, ICFs, IMPDs/INDs, etc.
All our clinical trial translators and experts work under binding non-disclosure agreements.

  • ISO Certified

    ISO Certified

  • Confidentiality

    Confidentiality

  • Accuracy

    Accuracy

Quality Control System

Our quality system is certified as compliant with the ISO 17100:2015 quality standard.

Our Clients

Leading Pharmaceutical Companies
Medical Device Companies
Contract Research Organizations (CRO)

Why Choose Us?

MedTrans works closely with our clients to develop CSPs that provide logical, consistent, and clear instructions for investigation teams, avoiding any ambiguity in CSPs translation. We offer the best quality clinical study protocol translation services and certified translation of clinical trial documents.

Reference
  • Spilker, Bert (1984). Guide to Clinical Studies and Developing Protocols. New York: Raven Press.

Online Inquiry

Verification code

Online Inquiry

Verification code