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

Clinical Data Management provides database development and data management for C5Research Core Lab data and for smaller, investigator-initiated, single and multi-center trials. 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.

Statistics

The C5Research Statistics team collaborates with investigators on the analysis of trial data and prepares the primary manuscript at the conclusion of the trial. In addition, several additional post-hoc manuscripts are usually developed in collaboration with the Trial Steering Committee, Publications Committee and investigators. Sponsor approval is obtained for all requests using the trial data. This exploration of the data and dissemination of the results through publication in top-tier, peer-reviewed medical journals are at the heart of C5Research’s mission as an ARO. To this end, and in response to medical journal dictates, C5Research must receive the trial data, preferably the trial analysis datasets, after data lock. 

Expertise

  • Protocol review of design and sample size
  • Review/input into statistical analysis plans
  • Review/input on CRF and Edit Checks
  • Independent validation of results
  • Support for manuscripts
  • Data Monitoring Committee (DMC) Services

Contracts & Finance

Our Research Contracts and Finance team develops, negotiates, and finalizes research contracts and manages the appropriate payments. Research Contracts and Finance will send out Letters of Indemnification on behalf of the sponsor and facilitate confidentiality agreements with the Investigators, sites and committee members. Contract templates are available for a variety of research agreements including: Confidentiality Agreements, Event Adjudicator Agreements, Data Safety Monitoring Boards or Data Monitoring Committee Member Agreements, Steering Committee Member Agreements, National Coordinator Agreements and Investigator Study Site Agreements. We use sponsor-approved alternate contract language available to facilitate and expedite contract execution. Sponsor approved agreements are distributed, tracked and followed-up on regularly through to completion.

The Contracts and Finance team will assess the protocol to develop a suggested site budget and corresponding payment benchmarks for the trial. Payments are made to the sites based upon the benchmarks met, per the clinical trial agreement. Detailed reports are provided to the sponsor for this activity.

Research Contracts and Finance will reimburse the various third party committee members based upon the established payment criteria detailed in their contracts.The team will perform comprehensive administrative accounting functions, including Sunshine Act reporting, for clinical trials.

Cardiovascular Clinical Research Information Services (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 around the selection and implementation of commercial off the shelf (COTS) applications and the internal development of applications provide the framework to demonstrate steps taken to address FDA 21 CFR Part 11 requirements.

Graphics and Design

Cardiology Graphics and Design provides professional graphic design services to C5Research and the Heart & Vascular Institute within Cleveland Clinic. Their goal is to ensure that any graphic materials required 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.