Today’s clinical trial operations leaders are in a challenging and expanding role. You are expected to increase study capacity, manage more complex trial protocols, accelerate study startup, and ensure timely sponsor collaboration – all while remaining hamstrung by limited resources, siloed data, stronger regulations, changing sponsor demands, and a growing site footprint.
Clinical trial operations leaders face increasing demands in 2019:
In response to these demands, clinical trial operation leaders have four key expectations to meet in 2019:
1. Increase study capacity with limited resources.
The most successful clinical trial operations leaders in 2019 will be those who can take on more studies without increasing their budgets or staff. This ability to scale requires maximizing operational efficiency through streamlined work-flows, new technology, marshaling resources, and training staff.
2. Drive process standardization across the organization.
Clinical trial operations professionals who can successfully drive process standardization across the organization through embracing new technology and effectively training all stakeholders will be key leaders in 2019. Ensuring buy-in from historically risk-adverse users, like investigators, will require a focused approach.
3. Streamline systems and processes to accelerate operations.
Clinical trial operations leaders must invest time in 2019 to evaluate current systems and processes to analyze where technology can streamline, automate, and accelerate operations. Work with a vendor who is focused on your strategic goals to uncover potential workflow adjustments.
4. Position the center as a site of choice with sponsors
With 72% of studies experiencing delays of at least a month, costing sponsors up to $8 million for each day4, the ability to harness technology to maximize site operational efficiency will lead sites that deliver to be a “site of choice.” Clinical trial operations leaders will be expected in 2019 to be able to report on studies accurately, have easy-to-use remote monitoring capabilities, and maintain proactive inspection readiness.