Cardiovascular Research

In 2007 Sarah Cannon Research Institute launched its cardiovascular research program. The network has grown to 11 hospital programs across the country working in collaboration with more than 125 physician investigators in multiple sub-specialties: interventional, electrophysiology, heart failure, cardiothoracic surgery, endovascular surgery, peripheral, and structural heart.

Services

Sarah Cannon Research Institute specializes in providing clinical research services for physician groups. Our expertise includes program development, clinical trial pipeline development, regulatory affairs, quality assurance, contracts and budgets, site management, patient recruitment and marketing support. By integrating these capabilities into our organization, Sarah Cannon Research Institute is able to be an effective liaison between the physician and sponsor, ensuring quick startup timelines, successful enrollment and accurate data reporting.

Research Excellence

SCRI Cardiovascular has conducted over 180 industry-sponsored trials and enrolled more than 2,000 patients since the program’s inception providing innovative approaches to clinical trial management.

Cardiovascular Leadership

gregory-fontana

Gregory P. Fontana, MD
SCRI Director of Cardiovascular Research, SCRI Cardiovascular

 

Dr. Fontana joined the SCRI Cardiovascular team in 2016 and serves as the Director of Cardiovascular Research. In this role he provides scientific and clinical expertise to develop sites and pipeline growth. In addition to his role within SCRI Cardiovascular, he serves as the National Group Medical Director of Cardiovascular Research and Innovation for HCA Healthcare and the Medical Director of Cardiovascular Services and Cardiothoracic Surgery at Los Robles Hospital and Medical Center in Thousand Oaks, CA.

Dr. Fontana received his medical degree from the David Geffen School of Medicine at UCLA, completed postgraduate studies at Duke and Harvard and has more than twenty years of adult and pediatric cardiac surgery experience.




sybil-hyatt

Sybil Hyatt, MSN
Director of Operations, Cardiovascular Research

 

Sybil joined Sarah Cannon in 2009 and serves as the Director of Cardiovascular Operations. In this role Hyatt manages the cardiovascular research teams for eleven hospitals within the HCA network.

Sybil received her undergraduate degree in nursing from Bob Jones University in 1995 and her graduate degree from the University of South Carolina in 1998 with an Acute Care Nurse Practitioner specialty. Sybil has focused on cardiovascular clinical research since 2000.

Program Benefits for Physicians

By working with Sarah Cannon Research Institute, physicians can add clinical research to their practice with minimal disruption to office workflow. Sarah Cannon Research Institute allows access to the latest in medical breakthroughs while diversifying sources of financial revenues. Sarah Cannon Research Institute, an industry leader in clinical trials, is dedicated to advancing solutions for patient care through clinical research.

Sarah Cannon Research Institute conducts the largest community-based research program in the nation, including clinical trials in multiple therapeutic areas through its affiliation with a powerful network of hundreds of physicians. Physician practices often lack the capital and infrastructure to manage clinical trials on their own.Sarah Cannon Research Institute works with existing groups to form a network of skilled researchers and supply the technical infrastructure and standardization support needed to effectively manage clinical trials in a community setting.

Program Development

  • Interacts with numerous pharmaceutical companies and contract research organizations to develop a deep and broad trial menu.
  • Reviews the feasibility of each trial under consideration through the weekly Protocol Review Panel, a multi-disciplinary panel consisting of representatives from Study Recruitment, Financial Services, Clinical Services, Quality Assurance, Data Management and Patient Recruitment.
  • Accesses multiple sites through one central organization.
  • Simplifies communication by serving as the point of contact for study start up from completion of CDAs and feasibility questionnaires to site activation.

Patient Recruitment

  • For applicable studies, coordinates all advertising and patient recruitment activities.
  • Pre-screens and pre-qualifies all present qualified patients.

Contracting and Financial Services 

  • Simplifies financial aspects by negotiating the budget reimbursement for all studies.
  • Manages all financial study obligations such as patient stipends, purchased services and contractor payments.
  • Tracks the progress of the trial and invoicing sponsors for payment in a timely manner.
  • Reconciles of amounts due and monies received on a monthly basis.
  • Reviews and negotiates all contracts to include appropriate payment terms and indemnification provisions.

Clinical Services

  • Assists with interviews, selection and hiring of research coordinators.
  • Provides in-depth training for new coordinators. Local training updates occur frequently.
  • Offers daily oversight, support and guidance to physicians and coordinators.
  • Assures that smooth and timely communications occur between the site, the coordinator and the sponsor.
  • Provides local site support via a Site Manager.
  • Provides oversight and support to enhance patient accrual.

Regulatory Submissions

  • Prepares initial regulatory packets and study documents with site-specific information for sponsor and Institutional Review Board (IRB) approval.
  • Prepares and submits required ongoing regulatory documents to the sponsor and IRB.
  • Minimizes rapid turnaround times for the preparation and delivery of regulatory packages.

Quality Assurance

  • Prepares comprehensive internal audit reports for any selected organization along with a plan for corrective action.
  • Provides oversight and a quarterly internal audit to assure compliance with all study-related activities.
  • Reviews all processes for compliance with GCP (Good Clinical Practices),ICH and FDA guidelines.
  • Reviews site research documentation and provides guidance in preparation for external sponsor and FDA audits.

Program Benefits for Sponsors

Site Capabilities

  • -20°C Freezer
  • IVUS
  • QCA
  • Central IRB
  • 1-2 Full-time CRC's
  • One monitoring location
  • Electronic medical records

Centralized Study Start Up

  • One regulatory package sent to Sarah Cannon Research Institute
  • Sarah Cannon Research Institute centrally completes all regulatory documents
  • Sarah Cannon Research Institute manages all central IRB submissions, all of our sites use central IRBs

Centralized Clinical Trial Agreements (CTAs)

  • Sarah Cannon Research Institute negotiates the CTA on behalf of the site
  • All CTAs are 3-party agreements between the site, Sarah Cannon Research Institute and the Sponsor/CRO
  • All payments are made directly to Sarah Cannon Research Institute who then pays each of the sites

QA Oversight

  • Sarah Cannon Research Institute conducts quarterly on-site audits of all strategic sites

Marketing and Patient Recruitment

  • Sarah Cannon Research Institute provides dedicated, full-time marketing and patient recruitment professionals

Clinical Oversight

  • Sarah Cannon Research Institute provides clinical oversight for strategic sites via physician leadership and dedicated clinical operations staff

Scientific and Investigator-Initiated Resources

  • SCRI Research Consortium provides Sponsor support to Sarah Cannon Research Institute research Investigators for creation and implementation of clinical trials

Cardiovascular Sites

Centennial Medical Center

Redmond Regional Medical Center

Chippenham Hospital

Henrico Doctors’ Hospital

Northside Hospital

Coliseum Medical Center

Riverside Community Hospital

Memorial Hospital Jacksonville

Medical City Dallas

Blake Medical Center

JFK Medical Center