About Clinipace Worldwide

Digital Clinical Research Organization (dCRO)

Clinipace Worldwide, a global digital clinical research organization (dCRO), specializes in serving the drug and medical device development needs of emerging and mid-tier life science firms.

Fueled by TEMPO™ – proprietary eClinical technology – our people ensure your success and execute a shared vision of technology as an enabler to bring both unsurpassed efficiency and quality to your development programs. It’s that shared vision and experience that improves performance, visibility and coordination for all stakeholders.

With specific expertise in oncology, among other therapeutic areas, Clinipace Worldwide has managed over 500 global contract research and regulatory projects. Clinipace Worldwide is headquartered in Research Triangle Park, North Carolina with offices in Overland Park, Kansas, Boulder, Colorado, Zurich, Switzerland, Munich, Germany, Tel-Aviv, Israel, New Delhi, India, Sao Paulo, Brazil, Buenos Aires, Argentina, and Lima, Peru.

The “Clinipace Way”

As a digital contract research organization (dCRO) we have pioneered an innovative service model that has transformed drug and medical device development by delivering technology-amplified services to improve performance, collaboration, and transparency across all stakeholders.

While similar in many ways to a traditional CRO, Clinipace has been uniquely built to deliver:

  • An expert regulatory team to set you on the right path
  • An innovative methodology that reduces clinical development cost and budget volatility
  • A streamlined, efficient operational approach that delivers the right infrastructure and resources
  • Experienced, therapeutically-focused clinical development staff organized specifically for emerging life science firms
  • A user friendly trial and data management platform that delivers real-time transparency and project control built on an affordable and highly available infrastructure

That’s the power of a dCRO. That’s the Clinipace Way.

Global Footprint

With Clinipace Worldwide, you get global expertise with local knowledge of clinical investigators, patient populations, regulatory nuances and cultural differences. With offices on four continents, you get global experience, without the global costs.

Clinipace Worldwide is headquartered in Research Triangle Park, NC, USA with additional operations in the following cities and countries, offering a full array of outsourced product and clinical development services:

  • Zurich, Switzerland (EU HQ)
  • Buenos Aires, Argentina (Latin American HQ)
  • Overland Park, KS, USA
  • Boulder, CO, USA
  • Sao Paulo, Brazil
  • Munich, Germany
  • Tel-Aviv, Israel
  • New Delhi, India

Additionally, we employ highly experienced team members with global access to South Africa, Asia and Pacific Rim.

Experience the Difference

When you’re looking for a clinical research partner, you’re looking for someone who understands and appreciates the unique needs of your program. Clinipace Worldwide has managed over 500 contract research and regulatory projects conducted globally working with almost 5,000 global investigator sites enrolling over 125,000 patients. Our experience is broad, but our expertise runs deep. More than 80 percent of our clinical operations staff has seven or more years of relevant industry and trial experience. We understand what makes your trial unique and are committed to providing you with exceptional operational, regulatory, and scientific personnel that are best suited to your specific trial.

Our People Make the Difference

Our experts bring extensive therapeutic knowledge and insight into assisting life science firms in developing and executing their regulatory strategies, clinical development, and post-approval research to ensure a successful drug and medical device development program. At Clinipace Worldwide technology is not an add-on to our service delivery; it is the backbone. As a dCRO, our experts are guided by the philosophy that using technology to drive project engagements optimizes outcomes.

We assemble the best team for each client engagement and believe that our dCRO culture yields substantial benefit for our clients. For example, we have very low employee turnover (less than 5%), which promotes stability and consistency. In addition, over 70% of our clinical staff has over eight years of industry experience and 90% of our regulatory, scientific, and medical team has over 15 years experience.

Our team provides expert guidance and operational execution across the spectrum of drug and medical device development - from regulatory strategies and filings to clinical activities to manufacturing, GxP compliance, and post-marketing research.

The Right Expertise

Drug Development
Our experts bring extensive therapeutic experience in building a well-defined strategy and operational plan to ensure the success of your drug candidate throughout its development lifecycle.

Medical Device Development
Our device experts will help you navigate the increasingly complex global regulatory and clinical landscape in support of your PMA or 510(k) application.

Clinical Development
From managing your entire clinical program to conducting an individual clinical trial (Phase I - IV), our clinical teams can help you affordably design and operationalize your protocol and gain visibility into your studies.

Regulatory & Strategic Development
Whatever the scale or complexity, we have the contacts and expertise to move your products from the lab to market while maximizing your success with regulatory authorities, worldwide.

Post Approval
Once a product is approved for use, understanding its efficacy and safety profile can be challenging. Our post-approval specialists deliver integrated phase IV research and registry services designed for your epidemiology, health economic, and safety programs.

Fixed-Price Guarantee

Our Right-Sized approach reduces costs since our business model is not based on the “optimize billable hours” mantra, nor does it rely on change orders. Optimized by our proprietary technology, Clinipace Worldwide delivers services under one of two Fixed Price models: 1.) Fixed Unit basis or 2.) Fixed Resource basis. Either way, we deliver the project at a price that is right for the project and you get predictability, not surprises.

That’s the power of a dCRO.