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Clinical Documentation Writing

Bringing new drugs to market requires thousands of pages of documentation to accurately capture timely clinical trial information. Clinical documentation (CD) is the creation of a digital or analog record detailing a medical treatment, medical trial or clinical test. Clinical documents must be accurate, timely and reflect specific services provided to a patient.

MedTrans offers the scientific expertise and industry experience required to provide the full range of writing and coordination services for the documentation demanded by your clinical programme. We can help to create or enhance any clinical or medical text, using the appropriate technical language to suit your audience.

Our services include:

  • Phase I-IV protocol/informed consent development
  • Phase I-IV integrated clinical statistics reports
  • Investigator's brochure development
  • Clinical study reports according to ICH E3 and eCTD format
  • Clinical study protocols and amendments
  • Subject information sheets and consent forms, including local language ICFs (prepared and reviewed by the relevant country)
  • Serious adverse event narratives

Our Strength

  • A Dedicated Writing Team. Our medical writing group consists of qualified PhDs and other experts.
  • Cohesive and consistent communication of key messages throughout your product lifecycle.
  • Sufficient Resources.
  • Documents Tuned to Different Audience.
  • Therapeutic and Development Area Experience.
  • Standardized and Compliant Document Formats. Ensure the highest standards and compliance with style guides and regulatory guidelines.
  • Application of industry best-practices and standards in document preparation.
  • Continuous and thorough quality control.
  • Flexible Outsourcing Pattern.
  • Management of your entire documentation cycle.
  • Efficient processes to meet tight deadlines. Project Delivery on Time and on Budget.

Irrespective of whether you wish us to act as your outsourced medical writing department or to produce single documents at times when your own internal medical writing team is over-stretched, our portfolio and expertise can be tailored to your needs. Contact us today to find out how our clinical documentation writing expertise can help you.

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