About us

Semita is led by Dr Yolanda Barbachano. Having worked both as a statistical assessor within the MHRA and EMA, and as a trial statistician within drug development, Yolanda brings rare, direct insight into how regulatory authorities evaluate clinical trial methodology, whilst also recognising the challenges faced by sponsors.

Understanding regulatory expectations in the area of statistics and study design can be a significant challenge for growing companies and those moving into new therapeutic areas. Semita provides focused, statistical support for those companies who lack internal expertise or would value a second opinion.

Whether evaluating the regulatory acceptability of an innovative trial design, pressure-testing an analysis strategy ahead of scientific advice, or preparing for high-stakes regulatory agency meetings, we can provide support grounded in what agency statisticians usually look for.

Link to CV