Introducing new drugs to the market is always an on-demanding scenario as drugs are the major influencing factors in healing any disease. With this never ending process, writing the clinical research documents has also become a high priority requirement for the sponsors.
Termed as Medical Writing ,this involves the process of drafting the entire trial data. And a good medical writing practice is that in which one focuses to document the clinical research data in accordance to regulatory compliances, design methodologies of the clinical trial and many more. Medical writing helps in understanding and documenting the trial specific data which is a major factor in clinical research process.
Maintaining the data quality while it is being drafted helps to ensure that a trial documentation is accurate enough as required. Data is expected to be drafted and maintained in an order such that it can be retrieved quickly when required especially in scenarios of regulatory inquiries.
Protocols, Investigator brochures , clinical Study Reports, Regulatory briefing documents , Manuscripts are some of the supporting documents for Regulatory Medical Writing.
Medical writing for the pharmaceutical industry are generally classified as Regulatory Medical Writing and Educational medical writing, wherein regulatory medical writing is intended in drafting the data for the approval of the drugs and devices.
CT Renaissance suite from MaxisIT has a regulatory compliant medical writing product named as eCollabora which takes care of end to end Medical writing needs related to a pirticurlar clinical trial.
Lets have a more insight into medical writing in terms of its types and advantages in the next article.
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