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Professional Clinical Trial translation Services in Vietnam

Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people.
Dịch thuật hồ sơ thử nghiệm lâm sàng
Dịch thuật hồ sơ thử nghiệm lâm sàng

What are Clinical Trials?

Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment, such as a new drug, diet, or medical device (e.g. a pacemaker or a surgical robot) is safe and effective in people.

What should be Included in an Application for Clinical Trial in Vietnam?

  • Study protocol
  • Clinical trial outline
  • Investigator’s brochure (IB)
  • Summary of brochure
  • Written application for appraisal and approval of the study protocol
  • Academic resumes and Certificate of GCP
  • Participant information sheet and volunteer letter
  • Scientific and ethical assessment prepared by a Biomedical Ethics Committee
  • Confirmation of participation by trial centers
  • Written application for drug clinical trial
  • Local written approval for participation in the trial

The documents contained in the Application for drug trial can be in print or electronic form depending on the intended use of the involved parties.

The Needs for Translation of a Clinical Trial Application

There are various needs for a translation of a Clinical Trial application, for example, into Vietnamese or English, including:

  • To obtain approval for the clinical trial 
  • To implement drug trial projects
  • To control the drug trial process by the sponsor
  • To obtain authorizing approval for a drug or medical device
  • To evaluate the efficacy and effectiveness of the clinical trial
The translation would allow your clinical trial documents to be available in multiple languages. At AM Vietnam, our translations may get certified by our own ATA’s certificate or by a State Notary to be legally valid, depending on the using purposes of the documents.

What are Key Factors to a Translation of a Clinical Trial Document?

As clinical trials involve human health, and even life, the requirements for a translation of a clinical trial document are, therefore, strict and zero-tolerable to mistakes and errors. 

Key factors to a translation of a clinical trial document:

  • The translation should be interpreted exactly as the original
  • The language use should be clear, formal, and easy to read
  • Medical professional standards should be ensured
  • Standard terms and phrases should be applied
  • The translation should be provided on schedule with absolute confidentiality
At AM Vietnam, we also develop our own set of criteria for each specific step, combined into a scientific and reasonable process to ensure that our final products are delivered to customer expectations.

Translation Process for Clinical Trial Documents at AM Vietnam

We are happy to share our reliable translation process for clinical trial documents as below:

Professional clinical trial translation in Vietnam

Each step in our process is performed by well-trained specialists with professional skills and outstanding working capability. All of these put a simple, yet clear reason why AM Vietnam is selected and trusted by various international clinical trial organizations for their trial projects in Vietnam.

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