Clinical Research

Clinical Research Organization (CRO) Services

At RCRI, we are scientists first — committed to the highest standards of professional excellence in CRO research and clinical trials. There are some CROs that have been around for a while, but none that have also delivered the most accurate, efficient, and sophisticated clinical research consulting services PLUS an integrated consulting partnership since 1999 like RCRI.


CRO clinical trials are only as good as their design

Trial designs and execution require thoughtful planning to achieve the most efficient acquisition of sound scientific evidence.

Our collaborative approach, and creative problem solving can save you time and money during the operational phase of your project. We support our clients with:

  • A customized approach to clinical strategy that delivers a program of high quality evidence through operational excellence, tailored to the unique needs of your product.
  • Guidance in selecting the study design (Frequentist, Bayesian, Adaptive) most suited to your business and regulatory needs.
  • An Integrated experience across all phases of your evidence development, from strategic consulting, trial design,  and planning biostatistical analyses,  through final analysis and synthesis of results and more.
  • Scalable tactics from small, simple pilot studies to large, complex pivotal trials.

Trusted, proven and respected

An experienced team makes all the difference in the success of your study. Our advisors’ breadth of expertise covers medical device clinical strategy, trial design, operationalization, data management, clinical compliance, biostatistics and medical writing.  Using our deep experience in both premarket and post market studies, we can quickly pinpoint areas for improvement or efficiency, identify unusual findings in the data, and work with you to anticipate and overcome challenges, while obtaining the necessary evidence at the right time in your product lifecycle.


  • Clinical Strategy
  • Clinical Study Design
  • Clinical Study Operations
  • Site Management
  • Site Monitoring Services
  • Database Development and Management
  • Data Management
  • Biostatistics Consulting
  • Medical Writing
  • Data Monitoring Committee (DMC) Management
  • Data Safety Monitoring Board (DSMB) Management
  • Clinical Events Committee Management (CEC)
  • Clinical Compliance/Auditing

“RCRI has been outstanding to work with from the beginning. They shared our commitment and dedication for conducting a high-quality, FDA-regulated clinical study and did so in a collaborative and results-oriented fashion. We very much appreciate the role RCRI has played.”

– CEO and President, Spinal Biologic Device

3 Factors to Clinical Trial Success


Integrated strategy + Flawless execution + Compelling evidence 


Maximizing the success of a clinical trial requires an integration of regulatory know-how with business savvy and a focus on flawless execution. As a result, our studies generate compelling evidence demonstrating value for all stakeholders in the timeframe that meets or even beats your schedule.

RCRI is a clinical research partner that brings a higher value to your entire evidence development process.

RCRI Clinical Research services brochure    DOWNLOAD


Intensive BIMO Preparation is Key to Successful Inspection Results for Sponsors and Sites

A medical device manufacturer conducted a successful randomized IDE clinical trial, but at the time of study closure they decided not to file the Premarket Approval (PMA) application for business reasons.  However, five years later, the business climate had improved and the company proceeded with its PMA application.  The sponsor knew this unique situation would present significant challenges readying the long-closed study sites for the expected FDA BIMO inspections.