Protocol development is a collaborative process that begins by clearly delineating a research question and pairing it with a research design that will answer that question.  The protocol provides the foundation for development of research collateral documents such as the Informed Consent Form and Case Report Forms.  

Accurate research budgeting is essential to understanding the true costs to conduct a research study. The budgeting process involves multidisciplinary collaboration to ensure that every aspect of the conduct of a study is anticipated and captured in the research budget. Once developed, the research budget becomes a powerful tool for contract negotiations.

Expertise is needed to conduct research, which is a systematic investigation designed to develop and contribute to generalizable knowledge. Accurate collection of high quality data is the key to obtaining analyzable results. Conducting research requires deep level planning and execution with high levels of attention to detail. 

Policies & Procedures (P&Ps) and Standard Operating Procedures (SOPs) establish guidance, consistency, accountability, efficiency, and clarity on the various aspects of a research program at an institution, no matter how small or large. Writing P&Ps and SOPs can be tedious, as it requires translating research regulations into practice at a specific institution.  

Research Compliance is an essential component of a robust research program. The regulatory requirements governing research are complex, and may feel burdensome to research programs and researchers. To maintain public trust, the development and implementation of a rigorous research compliance program is essential.

Human subjects research must be reviewed by an Institutional Review Board (IRB).  Federal regulations govern the work of IRBs. Regulatory submissions to an IRB can be overwhelming due to the different documents that must accompany an application and managing the ongoing communication with the IRB.

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