Medical Writing

Written communication can be a very powerful medium and we need to consider carefully what we are trying to achieve when using it.

- If the purpose is to provide information, what will the reader do with it?

- Does the reader actually need the information or just selected parts of it?

- How much details are required?

- What other information does it need to cross-reference?

Many a times, it becomes complicated when we are faced with a blank sheet of paper or computer screen and we need to consider how to craft the message carefully to achieve the desired result.

While on the other hand; very often in clinical research, the regulations and guidelines determine the information we need to provide. For example when a Sponsor applies for a clinical trial authorization, the appropriate documents need to be completed accurately before submission to the regulatory bodies.

Complying with regulations often gives little leeway in the type of information required. This can be both a help and a hindrance depending on the scope for interpretation of the questions that need to be completed. The situation may become complex when we have a set of guidelines that we have to comply with - in terms of definitive templates available in clinical research.

We at Consortium Clinical Research ease out the complex medical writing requirements of our clients by delivering the following components that are an integral part of the Clinical Research Process (including but not limited to) –

  • Assimilating Investigators’ Brochures;
  • Compiling Regulatory Dossiers;
  • Composing Clinical Study Reports;
  • Conceptualizing Patient Diaries;
  • Designing CRFs;
  • Drafting Informed Consent Documents;
  • Writing Protocols.

Information has been referenced from - Writing & Reviewing Skills, Jan. 2006.