Consulting Services

Compass Point Research is singularly focused on the business of clinical and translational research. We help our healthcare provider clients ensure adherence to good clinical practice and governing regulations, provide brand differentiation, improve financial performance and achieve organizational alignment among the medical staff. To optimize overall performance, Compass Point Research offers the following consulting services:


Clinical and Translational Research Program Development Strategic Planning

Compass Point Research has a long history of strategic planning in the form of stringent review processes. These reviews look at the mission, direction, and quality of the research programs, research support, collaborative interactions of the medical staff and administration, and other indicators of leading research programs. The reviews are used to articulate the most viable research portfolios and establish the priorities and goals for the research programs and administrative support in the following five-year period.


Risk Assessment and Corrective Action Assistance

Research is not often a core business of community based healthcare providers and thus adequate policies, procedures, and oversight are sub-optimal, exposing the organization to regulatory and financial risk.  Compass Point Research has extensive experience in identifying and quantifying FDA, OHRP and OIG regulatory compliance risk and developing and implementing necessary corrective actions.


Clinical and Translational Research Operations Assessment and Gap Analysis

Establishing and maintaining a regulatory compliant and financially viable research program requires efficient operations.  Compass Point Research identifies gaps and provides a detailed roadmap for implementing changes required for operational success as defined by our clients.  This is accomplished through benchmarking with like organizations as well as  focused reviews of Investigator Standard Operating Procedures, competencies and roles of Investigators and research personnel, historical operational performance, staffing levels and work flow.


GOOD CLINICAL PRACTICE, BILLING COMPLIANCE AND INSTITUTIONAL REVIEW BOARD AUDITING

Independent, third-party audits provide valuable insight into the quality of a clinical research program. They facilitate the monitoring of how well quality management systems are working, including whether the organization’s billing compliance, Investigator and Institutional Review Board policies, procedures and processes are adequate to meet regulatory requirements and published guidance.

Compass Point Research has conducted hundreds of clinical trial and Institutional Review Board audits utilizing standardized audit procedures, tools and reports.  Whether organizations have specific concerns or are seeking routine external monitoring, audits are conducted by experienced and certified industry professionals.  In addition, audits are confidential and considered the organization’s internal work product.