Project & Clinical Operations Management

CRA Solutions is involved in all aspects of developing and implementing new clinical trials: protocol design, FDA strategy meetings, SOPs, training, regulatory submissions, etc.

A cross-functional clinical operation plan is the key to meeting deadlines, staying with budget, and mitigating issues. We begin by developing a clinical operations plan to define expectations and timelines. We create study tools, develop contingency plans to address potential issues, and track quantifiable metrics to measure progress.

Most common problems that occur during clinical research are preventable. Before study start-up, CRA Solutions will perform a protocol feasibility assessment and source document gap analysis to identify “at risk” data and procedures (those that are outside of standard medical practice). We then provide targeted training and tools to site staff so they are prepared to conduct a successful trial.

At the site level, CRA Solutions can develop plans for training, subject recruitment, staffing, reporting, communication, and action item resolution.