Medical Writing Services

 

What is Medical Writing in a Clinical Trial? 

Medical writing services in clinical trials are professional and specialised support services provided to pharmaceutical, biotech, and medical device companies during the development of new drugs or medical devices. The main purpose of these services is to ensure the accurate and effective communication of scientific and clinical data generated from clinical trials to regulatory authorities, stakeholders, and the general public. Clinical trial study Protocol, clinical investigation plan, Investigator’s brochure, informed consent, and clinical study report (CSR) are examples of clinical trial related documentations that medical writers can help with.  

Medical Writing Services 

At Obatica, we believe the quality of medical writing services in clinical trials is critical to

medical writing services for clinical trials Australia

ensure that the data generated from clinical trials are presented clearly, accurately, and in a format that complies with regulatory requirements. Through our expert medical writers, we assist sponsors achieve successful regulatory submissions, obtain market approvals, and ultimately improve patient outcomes. We provide medical writing services for both investigator initiated and industry-sponsored clinical trials. 

Besides clinical trial study protocol, Obatica also has extensive experience with creating investigator’s brochure (IB), patient  informed consent sheet/form (PICF), and clinical study report (CSR).  

By default all of Obatica’s medical writing works are reviewed and quality checks by experienced clinical trial experts including specialist medical doctor and site expert. These experts will be able to elevate your clinical trial study documents to a ready stage and avoid the common avoidable pitfalls.   We see this process as an important part of medical writing to ensure quality and relativeness to the end goal. 

Book in for your free consult here to learn more about our medical writing services 

Obatica’s Medical Writing Services: 

  • Protocol review, writing and development (full protocol development) 
  • Participant information consent sheet/form (ICF)
  • Investigator’s Brochure creation 
  • Clinical study reports creation 
  • Medical writing for abstract and manuscript 
  • Support and assistance with conference/journal submission 

What customer says about Obatica’s Medical Writing Services

Obatica recently performed two medical writing services project for a clinical-stage Biotechnology company. The client has a very ambitious timeline which Obatica is able to handle it nicely. Here is what ourclient has to say.

“Obatica is one of the best medical writers that we have worked with.  We were impressed not only by the high quality of their work but also their ability to deliver the protocols under very ambitious timelines, customer-orientated attitude and overall value.  We look forward to working with Obatica again on our future medical writing projects.” 

Kon Yew Kwek, BMBCh, DPhil.  Vice President, Clinical Development, Hummingbird Bioscience

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