Rochester Clinical Research understands that the key to any successful clinical trial is having reliable and accurate data entered in a timely fashion. We set high expectations for ourselves in regard to the data that we provide to the Sponsors, and the care that we provide to our study volunteers. Quality of care for our patients is our top priority, but ensuring their time and effort is worthwhile is a close second. We do this by guaranteeing to them that the time they spend working with us and the data collected from their efforts will be used to further medical research. The way we do that is by providing high quality data to you, our Sponsors.
Rochester Clinical Research has a number of SOP’s, templates and forms to help aid in the quality of our data collection. We have two Medical Doctor’s, two Nurse Practitioners, six Registered Nurse Clinical Research Coordinator’s, and one Registered Dietitian/Masters of Public Health/Certified Diabetes Educator Clinical Research Coordinator on staff. Additionally, we have three full time Research Assistants dedicated to entering data who boast an average turnaround of 24 hours. Beyond that, we have instituted a Quality Assurance department. Since the onset of the QA Department we have seen a decreased number of monitor findings at site visits, and increased praise from monitors on the accuracy of our data – making their time spent at our site more productive.
Our QA Department performs study audits on a regular basis. The following is an abbreviated list of duties our Quality Assurance Department performs in order to ensure you receive data of the utmost quality:
- Review study protocols, EDC screen shots, and source documents to ensure that the source accurately and completely reflects the protocol’s requirements and site’s documentation requirements
- Review completed source documents for accuracy, completeness, and legibility
- Compare data in source documents to data transcribed in EDC for accuracy
- Identify trends in errors to initiate improvements in source document flow, collection and site processes
- Review regulatory binders for proper organization, filing, delegation of authority, documentation and completeness of training
- Review site processes and forms and suggest revisions that will make the collection of data more streamlined
Adherence to the above processes, in combination with FDA guidelines for research and good clinical practices is what leads RCR to constantly evolve, improve, and efficiently provide your company with quality data.
What gives us an advantage over other research sites? It is our commitment to providing high-quality work. Here at RCR we strive as a team to exemplify quality in all aspects of clinical research. We embody our company’s mission to excel in our field by providing quality care for study volunteers and quality research data to sponsors. As a team, we take that thread of care from the beginning, and weave it through all we do, ultimately providing you with data of the highest caliber.