The data management process is one of the hallmarks of RCTS. Your data is never unattended as it moves through our system, and sign-off forms are required at every step to ensure complete accuracy. This attention to detail helps us ensure data integrity. Once a test is underway, our quality control staff conduct a complete review of all data points and study documentation to ensure accurate, attributable and defensible test results.
All RCTS reports adhere to International Conference of Harmonization (ICH) standards. Reports detail the conduct of the study, the results that were obtained and conclusions. While detailed, they are also very readable and very user friendly. We archive all information, both locally and at remote sites. Data and reports can easily be retrieved from archived studies should the need arise.
Thanks to our unique combination of technology, processes, quality control measures and state-of-the-art facility, you can count on clinical testing at RCTS to be done right the first time.
Source Documents and Case Report Forms
While the protocol, standard operating procedures and regulations/guidance documents describe the conduct of the study and the manner in which it is to be conducted, source documents and case report forms (CRFs) are the actual, contemporaneous record of the clinical trial. Because of our lengthy experience with clinical trials, we have become expert in the design of source documents and CRFs. Because of their critical nature, these documents are available for review and approval by our sponsors.
Electronic Data Capture and Electronic Case Report Forms
More and more clinical trials are moving toward electronic data capture (EDC) for source documents and CRFs, particularly for pharmaceutical trials. RCTS has worked with EDC systems of several pharmaceutical companies. We are thoroughly familiar with the training in the use of EDC and recording of data within EDC systems.