Coding for consistency – to safeguard your outcomes
In the course of conducting a multicenter clinical trial, a variety of data is generated and collected, aggregated and analyzed for possible trends. This data, collected on Case Report Forms (CRFs) for paper-based trials or electronic Case Report Forms (eCRFs) for web-based trials, contains information such as Adverse Events (AEs), Medical History (MH), and Concomitant Medications (CM). It is often the case that the data collected has been recorded in different fashions, especially across international study sites.
It becomes very important to organize all data uniformly for optimal interpretation and analysis, so the FDA and other regulatory authorities require medical terms entered into CRFs and eCRFs be coded to industry standard dictionaries. At Insight Clinical Consulting we have years of experience managing critical medical coding processes to prepare submissions for regulatory authorities. We use MedDRA for adverse events and medical history and WHODrug for concomitant medications.
Reach out to us for help with your medical coding needs.