Approach

Our Integrated Approach Separates RCRI From Other Medical Device CROs

Providing comprehensive solutions for our innovating clients is what we do. We achieve it through our Integrated Approach, an approach that makes us a totally unique firm. Other medical device CROs only focus in one area and lack the single-most critical piece to success: very experienced, very savvy advisors who know the kinds of strategies that help navigate you through today’s marketplace landscapes – and landmines.

Today’s healthcare environment is complex. Payers want proven “value”. Providers want solutions to make their practices effective and efficient. Patients hold more purchasing power. Regulators want bigger margins of patient protection. Investors want compelling evidence. A smart partner is an important key to your success.

Unlike other medical device CROs, our Integrated Approach means we look at your project with both clinical and strategic eyes, and adeptly apply our interdisciplinary knowledge throughout the duration of the process. We do things like ask “why?” first, and often. Our experts use a stacking process, so that each project builds upon the next and adds to the whole. And, as with any team, an interactive relationship is foundational and means we achieve greater results together.

Our Integrated Approach Drives Market Success

  • Discovery

    • Regulatory Affairs & Strategy Development
    • Health Economics & Reimbursement
  • Evidence Formation

    • Clinical Study Design & Operations
    • Biostatistics & Information Management
  • Post-market Compliance

    • Post-market Evidence Development
    • Quality Systems Support
  • Development

    • Clinical Strategy
    • FDA/Regulatory Body Strategy Negotiation
  • Regulatory Submission

    • Regulatory Body Negotiation & Response

Supporting you through all phases of product development

From simple modifications of market-released products to novel combination products, our deep experience and proven integrated approach removes obstacles to expedite approvals with major regulatory agencies and notified bodies around the globe.

Our Integrated Approach Brings Market Success

Because we scrutinize every detail of your product and business goals, we are more likely to uncover opportunities, reduce cost, and improve timelines that other medical device CROs miss. From the start you’ll be partnered with a truly collaborative and experienced team of scientists who will work side-by-side with you to move your discovery process and product toward the marketplace, and keep it there.

Benefits of our Integrated Approach:

  • Experience fewer regulatory hurdles
  • Get products to patients sooner
  • Become profitable sooner
  • Achieve independence

“RCRI has been fantastic, great quality. It has been flawless working with them.”

– Head of Clinical Studies, International Class II Device Manufacturer

Comparing Total Costs: Medical Device CROs

Where does RCRI stand in the overall cost spectrum? Our clients get more for their investment. Beware of medical device CROs who underbid projects at first, then go on to charge 25% to 30% more in the form of change orders. RCRI delivers total value, including insight and foresight for innovations that meet the demands of a challenging and ever-changing market. Our ultimate goal is to be the strategic partner that helps innovators bring life-bettering, life-saving medical solutions to people all over the globe.

Expert awareness. Exact practices. Effective results. RCRI is the medical device CRO that works hard to positively impact medical device innovation.

RCRI Overview brochure    DOWNLOAD

 

CASE STUDY:
Overcoming remediation challenges while keeping operations running

After buying a long-established medical device manufacturer, a large multinational corporation found major shortcomings in quality systems and regulatory affairs strategies after an internal audit. They knew they had to immediately develop complete, harmonized quality systems in order to avoid regulatory findings.

More