We benefit from a unique operational capability in designing and managing large-scale human clinical research studies. With a disciplined approach — established operational infrastructure, demonstrated workflows, and a commitment to first engaging in pilot efforts — we are positioned for success before a study kicks off. Our competency, knowledge base and stress-tested infrastructure mean these large-scale human studies can launch quickly, operate efficiently and meet study objectives. 

Bolstered by an expert core staff, our clinical research team is able to nimbly customize its operations leveraging its tried and tested workflows. The experience provides an advantage over other research settings which might need to spin up a new structure — developing de novo operational flows, recruiting, hiring and training new staff, and building infrastructure for recruitment, data collection and storage, and data analysis.

With our robust operations capability, we are uniquely positioned to optimize initiation of research projects, deliver on key objectives and, ultimately, make the most impact.

What’s involved

Beginning with the proposal development process (at the fund-seeking stage) and continuing through the contracting/award stage, our operations team works with investigators and study sponsors to define operationally feasible study goals and to identify the data, processes and resources necessary to support them. 

Once the project is funded, and we have aligned the protocol with the study goals, the team customizes the project architecture to meet study needs and implements efficient workflows to securely collect longitudinal data from large samples of participants. 

Beginning at study kickoff, team members steer day-to-day study operations for optimal data collection.

Throughout the study duration, the operations team engages in continuous assessment of study progress and resources, and works with investigators and study sponsors to implement as-needed protocol revisions.

Below is more detail about what is involved with project architecture and operational flows used to support DGC clinical research projects.

Activity Related to Project Architecture

• Cross-collaboration with internal and external teams to support operational needs across teams 
• Designing and implementing participant compensation that supports study goals
• Building custom online screening and enrollment workflows, including electronic consent
• Developing recruitment strategies to target specific populations to meet enrollment targets
• Creating custom study dashboards for stakeholders to monitor study progress and enrollment targets
• Building and maintaining the study database(s) (REDCap) responsive to the study design and determining where each data type will be stored (e.g., maintained in the main study database or in another location on the server)
• Building informatics infrastructures to support secure data collection and storage in the selected applicable environment for availability to researchers 
• Creating data transfer pipelines to support the secure exchange of data with collaborators, partners and vendors, and facilitate ongoing and final data analyses
• Managing data storage and analytic environments to control access and ensure compliance with applicable study restrictions

Activity Related to Project Operational Flows

• Implementing participant recruitment, screening and consent processes
• Administering clinical interviews
• Establishing and managing risk protocols 
• Distributing and managing participant materials and equipment needed to support remote data collection, such as study devices (e.g., Apple Watches for the collection of remote digital sensing data)