Internal Support Services

Regulatory and Quality Assurance

The Regulatory and Quality Assurance team is comprised of Compliance Specialists experienced with the regulatory requirements of both the Sponsor and Investigator. Regulatory and Quality Assurance provides C5Research with regulatory consultation and a comprehensive, multifaceted Quality Assurance Program and offers the following services:
  • Independent Auditing
  • Good Clinical Practice (GCP) Training
The primary goal of the Regulatory and Quality Assurance team is to promote data integrity and protection of human subjects by ensuring compliance with Federal Regulations, GCPs, and sponsoring agencies policies and procedures governing the use of human participants in research.

Data Management

C5Research Clinical Data Management provides FDA/Pharmaceutical Industry focused clinical data management for the C5Research Core Labs (CEC, Angiography, IVUS, CIMT, Echo) and for smaller investigator-initiated trials within the Heart and Vascular Institute. The team is experienced in all aspects of data management:
  • CRF development
  • Database design
  • Data tracking and data entry
  • Data Edit Checks/Validations
  • QC audit
  • Query issue/resolution and data lock
  • Data transfers
All aspects of C5Research CDM activities are performed in accordance with CDM Standard Operating Procedures and Internal Operating Procedures, as well as GCP and ICH Guidelines

Cardiology Clinical Research Information Systems (CCRIS)

The Cardiovascular Clinical Research Information Services (CCRIS) group supports the information technology needs for C5Research.  As a business unit IT group within the Heart and Vascular Institute at Cleveland Clinic, CCRIS is a liaison for the enterprise Information Technology group which provides network, file storage, messaging, hardware and database services.  CCRIS provides guidance to the C5Research functional groups on how to leverage technology to help project teams be efficient and ensure data integrity throughout the clinical trials phases.  Additionally, CCRIS provides help desk and 24-hour support for all C5Research personnel.
 
The CCRIS team is responsible for the review, interpretation and implementation measures to support FDA 21 CFR Part 11 as it relates to electronic records and electronic signatures for computerized systems.  SOPs directing the selection and implementation of commercial of the shelf (COTS) applications as well as internally developed applications provide the framework to demonstrate steps taken to address the requirements FDA 21 CFR Part 11.


Graphics and Design

Cardiology Graphics and Design provides professional graphic design services to C5Research at the Cleveland Clinic. Their goal is to ensure that any graphic materials C5Research requires reflect the professionalism and high quality of the #1 Heart Center in the US.

Graphics has three very talented, degreed professionals who design and create research study tools, presentations, manuscript figures, newsletters, brochures, trial logos, as well as, maintaining the C5Research website