Clinical Trial Documentation


There is a huge increase in the number of global clinical trials being conducted during the current decade. The need to conduct trials on a larger population as demanded by the regulatory authorities, as well as conducting trials over a longer period is making pharmaceutical companies and clinical research organizations (CROs) go global.

Among the popular destinations for conducting clinical trials are the South Asian countries like Pakistan, Bangladesh, Sri Lanka and especially India. A large population which has resulted in easier recruitment of subjects, lower costs of running the trials and availability of trained manpower/organizations to conduct the trials has resulted in almost a 100% growth in the number of clinical trials conducted in India over the past two years.
An important aspect in success of clinical trials is proper localization of documentation related to clinical trials such as Patient Information Sheet, Informed Consent Form, Study Protocol, Patient Diary etc.

Inforays has a special emphasis on translation of documents related to clinical trials.

The various activities in this area which are handled by us include
  • Project Management
  • Translation
  • Proofreading
  • Back translation
  • Reconciliation & linguistic validation

The translation process is the following- First a native language translator does the translation from English into the target language. The proof reader reviews the translation. The translated file is then sent to another translator who translates it back to English.

Quality control then compares the two files and resolves any problems with the forward or back translator.

The Inforays Project Manager oversees the entire project to deliver quality documents to clients within deadlines.
Some clients may choose to engage us for only a portion of the project.

For a free leaflet on “Managing translation of Clinical trial documents into Indian languages”, write to info@inforays.net or click here.

 
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