Clinical Trials, CROs and Medical Writing

In the past, I have written about the drug regulatory process in the United States and why it is important that medical writers understand that process.

Medical writers are often responsible for creating the documentation required for a drug's clinical trials. They can work directly for the pharmaceutical company doing the trials or for a Contract Research Organization (CRO) that provides medical writing services. 

An article on the DialedIn blog, describes this service model:

There are two types of service provider models used by emerging pharmaceutical companies to complete Phase I studies: the full service Phase I model and the ala carte model. Some Contract Research Organizations (CROs) provide full Phase I services which consist of the following:

• Study Site Services (IRB approval, drug packaging, medical monitoring, consenting, enrollment and randomization)
  
• Clinical Laboratory Services
  
• Drug Concentration Assay Services
  
• ECG Services
  
• Pharmacokinetic Modeling
  
• Biostatistics
  
• Clinical Data Management
  
• Clinical Study Monitoring
  
• Medical Writing
  
• Safety Reporting
  

Some CROs may also provide protocol development services. The advantages of the full service model are continuity of services and a single contract with a single provider.

Some emerging pharmaceutical companies make good use of the ala carte model for research services. In this model, a set of service providers is selected to provide the above Phase I services with each provider covering its niche area of expertise. For example, a particular CRO may be strong in biostatistics and clinical data management and would provide only those services on the trial. While the management of this type of model is more challenging for the sponsor company, it can provide a better end product.

CROs are great places for new regulatory writers because they can be exposed to the many facets of clinical trials (and because CROs may hire more junior medical writers than the pharmaceutical companies). So if you are seeking to break into regulatory writing, consider working for a CRO.