WIB Profile: Cutting The Length, Cost, And Complexity Of Clinical Trials

Sophie McCallum has spent almost four years with clinical solutions firm Clinovo, currently serving as its director of operations. In this position, McCallum oversees and manages the marketing, HR, finance, and inside sales departments. She also works with the governance team to plan and implement corporate vision and strategy, develops strategic plans and direction for products and services, develops tools and controls to track company profit margins and department budgets, and analyzes business and operation procedures to increase company efficiency and worker productivity. In this Women In Bio profile, McCallum discusses her role in helping build the company, and trends she sees occurring in the clinical research space.

1. What do you believe is the biggest trend impacting firms that do clinical research?

Despite the growth rates in our industry, there are a number of trends making clinical research more lengthy, costly, and complex. One is increased regulatory requirements, especially relating to data collection. Personalized medicine, biomarkers and orphan drugs are setting the trends for smaller and faster clinical trials with accelerated approval pathways. However, the overall complexity of clinical trials has been on the rise, as regulatory bodies are requiring larger amounts of data to provide evidence of a drug’s safety and efficacy. This implies more endpoints and analysis, ever more-challenging protocols, and increasing numbers of patients per program needed. Thus sponsor companies need to face high patient recruitment costs and handle more data – and paper – than they ever used to. This is driving the cost of clinical research significantly higher...