Enhancing Data Quality and Commitment to Excellence in Clinical Research
At Rochester Clinical Research, we recognize that reliable and accurate data entered in a timely manner is vital to the success of any clinical trial. Our unwavering commitment to providing high-quality data to our sponsors and exceptional care to our study volunteers sets us apart. Patient well-being remains our top priority, closely followed by ensuring their time and effort are valued. We guarantee that the data collected during their participation will contribute to advancing medical research. This commitment drives us to deliver top-notch data to you, our valued sponsors.
To ensure the highest standards of data collection, Rochester Clinical Research employs a range of Standard Operating Procedures (SOPs), templates, and forms. Our dedicated team comprises Medical Doctors, Registered Nurse Clinical Research Coordinators, and Registered Dietitian, Masters of Public Health, Certified Diabetes Educator Clinical Research Coordinator. In addition, we have full-time Research Assistants who excel at data entry with an impressive average turnaround time of 24 hours. Moreover, we have established a specialized Quality Assurance (QA) department, leading to decreased monitor findings during site visits and increased accolades for the accuracy of our data, thereby maximizing monitor productivity.
Our QA Department performs regular study audits, undertaking the following essential tasks to ensure the utmost quality of the data we provide:
- Thoroughly review study protocols, EDC screenshots, and source documents to ensure accurate reflection of the protocol’s requirements and the site’s documentation criteria.
- Scrutinize completed source documents for accuracy, completeness, and legibility.
- Cross-check data in source documents with the data transcribed in the Electronic Data Capture (EDC) system to ensure accuracy.
- Identify error trends to implement improvements in source document flow, data collection, and site processes.
- Conduct meticulous reviews of regulatory binders to ensure proper organization, filing, delegation of authority, documentation, and training completeness.
- Assess site processes and forms, providing valuable suggestions for revisions to streamline the data collection process.
By adhering to the above processes, in conjunction with FDA guidelines for research and good clinical practices, Rochester Clinical Research continually evolves, improves, and efficiently provides your company with unparalleled data quality.
What sets us apart from other research sites is our unwavering commitment to delivering exceptional work. At RCR, we strive as a unified team to embody quality in all aspects of clinical research. Our company’s mission is to excel in our field by providing quality care to study volunteers and sponsors alike. We consistently weave this thread of care throughout every endeavor, ultimately ensuring the highest caliber of data for your research.
Rochester Clinical Research Mission Statement and Commitment to Quality:
At RCR, our mission is to excel in the field of clinical research by providing quality care for study volunteers, delivering top-notch research data to our sponsors, and fostering a team-oriented workplace focused on excellence.
Our dedicated Quality Assurance department has played a pivotal role in our success. Since its establishment, we have witnessed a significant decrease in monitor findings during site visits and received greater praise for the accuracy of our data. The QA Department conducts regular study audits, performing various critical duties to ensure sponsors receive data of the utmost quality, including:
- Rigorous review of study protocols, EDC screenshots, and source documents to ensure compliance with protocol requirements and documentation standards.
- Thorough assessment of completed source documents for accuracy, completeness, and legibility.
- Cross-referencing data in source documents with the data transcribed in the EDC system to ensure precision.
- Proactive identification of error trends to drive improvements in source document flow, data collection processes, and site procedures.
- Comprehensive review of regulatory binders to ensure well-organized filing, delegation of authority, documentation,