Cardiovascular Clinical Trials

We have the EXPERIENCE You Need to Manage Your Cardiovascular Clinical Trial

With specific expertise in cardiovascular, oncology and CNS, among other therapeutic areas, Clinipace Worldwide has managed over 90 contract research projects conducted globally at almost 3,000 sites with 100,000 patients.

Clinipace offers unmatched expertise in providing emerging and mid-tier biopharmaceutical and medical device firms technology-driven contract research services. With more than 80% of our clinical operations staff having seven or more years of relevant industry and trial experience we provide exceptional operational, regulatory, and scientific guidance and oversight to your trial.

Our cardiovascular clinical trial experience includes managing wide-ranging cardio projects, including:

  • Phase 2 Cardiovascular Medical Device


  • Phase 4 Hypertension Drug


  • Phase 4 Heart Valve Replacement Medical Device


  • Registry Stroke Care Quality Improvement


  • Registry Heart Valve Replacement Device


  • Investigator-Initiated Study Stroke Health Management

How Can We Help You?

Trends in development of cardiovascular drugs have been mixed in the last year. While some companies announced that they are abandoning early cardiovascular drug development, others have made significant efforts to enter this area. Many late-stage failures have occurred due to unmet clinical needs in the cardiovascular disease area for subspecialties like hypertension, lipids, anti-thrombosis, ischemia and others such as inefficient approaches to target discovery and validation, lack of optimizing tools and biomarkers in the development process, and transparency conflicts.

Given the high stakes involved, running a successful cardiovascular trial can result in high returns.  Before embarking on a cardiovascular trial, teaming with the right CRO can reduce trial complexity and result in a more efficient trial. 
There are many special considerations you should take into account, including:

  • How to determine the best eligibility criteria and stick to it


  • How to choose the right investigator to increase enrollment (this often means going outside of the US to get the best participants for your trial)


  • Why you need to consider the role of technology in reducing trial complexity and running a more efficient trial:

    • - Partnering with a CRO to monitor which sites are getting patients on board and whether they meet eligibility requirements

    - Partnering with a CRO to keep down prices through licensed technology

    - Increasing trial efficiency through centralized data, standardized processes, branded methodology, and integrated site management with monitoring and regulatory aspects

    - Collecting and analyzing real-time data to track study results and implement corrective action, if required

  • How to develop and track patient treatment plans

Clinipace Cardiovascular Trial News

Friday, March 5, 2010
With drug pipeline brimming, outlook for CROs brightens (Triangle Business Journal)

Olson is skeptical about growth in the number of new drugs under development. He says some companies are flattening or even shrinking their R&D budgets. “If that’s the case for the industry, then CRO growth is going to have to come from increased outsourcing penetration because the pie won’t be getting larger, at least for now,” he says. Olson says oncology products are the single largest driver of the growth of compounds in clinical development. Cardiovascular and central nervous system compounds are also significant contributors to growth.

Wednesday, May 06, 2009
Clinipace Expands its Team of Clinical Development Experts

Williams explained, “Over the years, Clinipace and our team have conducted and provided oversight for dozens of clinical studies. While not specializing in any one therapeutic area, we have significant experience in managing trials and registries across North America with a focus on Cardiovascular, Central Nervous System, Psychiatry, Oncology, Gastrointestinal disorders, Dermatology, Biologics and Immunology. By operationalizing the trial protocols with our technology-driven model, sponsors are assured that our experienced clinical trial specialists in project management, clinical and site monitoring, data management, and biostatistics deliver the solution and budget to fit any trial or project.”

July 31, 2008
On-X Life Technologies Significantly Reduces Study Management Costs with TEMPO from Clinipace

On-X saves over $2 million in conducting the company’s prosthetic heart valve clinical trials – a phase IV and safety registry – with TEMPO research platform from Clinipace. Upon receiving the U.S. Food and Drug Administration (FDA) approval in early 2006 to conduct an investigational device exemption (IDE) clinical trial of the On-X® Prosthetic Heart Valve at reduced anticoagulation levels following review and approval by clinical centers, On-X began the process of evaluating partners to assist with study management.

June 21, 2006
EDC Needs at Heart Valve Maker MCRI

Based in Austin, Texas, Medical Carbon Research Institute (MCRI) is working on a new heart valve that features an exceptionally pure, smooth, biocompatible plastic. John Ely is MCRI's executive VP for regulatory affairs. We're hard-pressed to remember a more savvy outlook on the electronic data capture (EDC) space. Ely has been in the industry for a couple decades, including seven years at the FDA. And for most of that time, Ely has been interested in whether modern communications can expedite the process of creating new medical devices. "I've always been interested in ways to leverage technology to improve the way of doing this," says Ely. "Frankly, it's always been made too difficult."

Tuesday, March 28 2006
Clinipace Inc. Chosen by Medical Carbon Research Institute to Support Landmark Heart Valve Research

The On-X valve is an industry-leading carbon prosthetic heart valve developed and manufactured by MCRI. It is the first mechanical heart valve to receive FDA-approval for a clinical trial exploring associated lower anticoagulation therapy levels. Successful completion of this clinical study could result in the On-X valve becoming the only mechanical heart valve approved for low-dose anticoagulation therapy. Such FDA-approval would not only represent a considerable competitive advantage for MCRI, but would also be advantageous for On-X valve recipients.

What Our Customers Have to Say


"Since beginning the trial, site investigators found the data entry simple, the web-based platform convenient, and the paperless system has huge advantages.Investigators also told On-X officials that the serious adverse event notification is particularly helpful. The software deployed quickly, and the investigator sites love it. Several investigators have actually volunteered to tell us how well digital CRO software works in managing the study."

John Elym, Executive Vice President for Regulatory Affairs for On-X Technologies On-X Prosthetic Heart Valve