Industry Analysis

The legacy architecture of clinical data management, which relies on paper source documents transcribed into Electronic Data Capture (EDC) systems, introduces a critical vulnerability known as the "transcription gap." This gap creates latency between patient events and data visibility, necessitating expensive, retrospective Source Data Verification (SDV).

Every winter, the ritual is the same. Public health officials make a calculated prediction about which influenza strains will dominate, manufacturers race to produce a vaccine, and we cross our fingers that the "match" is good. Some years, efficacy is as high as 60%. In others, it drops to a discouraging 10%.

The development of mRNA COVID-19 vaccines appeared lightning-fast, yet the scientific foundation