Eric Vestal is the senior director of Global Regulatory Operations at Clinipace.

I was recently asked to speak at the DIA EDM and ERS 2014 event held the end of September in Washington, DC. This meeting was developed in collaboration with the Document and Records Management and Electronic Regulatory Submissions Communities. According to their website, following the success of last year’s combined EDM and ERS/eCTD events, EDM 2014 continues to explore evolving global trends in e-records, systems and e-context in the Clinical and Regulatory space.

I participated in the track, “Managing and Developing Regulatory Submission Operations.” Noted industry expert, Chris Buckley of Astellas Pharma, served as session chair; other speakers included Robert Connelly of Global Submit and Muriel Spooner of Celladon Corp.

As noted in the program overview, both industry and agencies must continually reassess standards, processes, and technology to be operationally positioned to meet ever-changing regulations and processes. In other words, regulatory operations can be a complex space, requiring a diverse set of technical, regulatory and business skills

Our group explored how to manage the developing global regulatory operations groups from the vantage point of several perspectives, including technology dependency, timeline management, risk, a changing and increasingly standards-based regulatory submissions environment, training of staff, vendor evaluation and selection, and budget requirements.

My role in the particular session was to provide perspective on how the digital CRO (dCRO) has unique differences relative to a sponsor or service provider.

In my experience, building and integrating global regulatory operations should be assessed from the perspective of a complete system comprised of people, process and technology, integrated over time. The key to success is a global unified quality process while maintaining flexibility through different operational demand-and-delivery models, and being cognizant of which is applicable when. For example, assembly-line functional step flow has very different pros and cons relative to the master integrator (super publisher) approach. Risk Models include “parts in the box,” “drip by drip,” and “on demand,” with each one tending to preferentially sacrifice one component of the time-cost-quality matrix. Awareness of which model is applicable to a project is critical to managing it. Demand and capacity do not always align and techniques may include project leveling, component or functional outsourcing, project outsourcing or global internal augmentation. The long-term opportunity, unique to the dCRO paradigm, lies in the ability to leverage interfaces along the clinical-regulatory spectrum, including each functional, data and metadata.

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