Contract Research Organizations and Clinical Trials

P-Wave has focused some of their products on the records and data management needs of contract research organizations including those conducting clinical trials. There is a critical need for implementation of better data and records management systems in the CRO and clinical trials market. It is difficult to provide sufficient chain of custody tracking for pharmacokinetic (PK) samples with paper-based systems because they are inherently slow and error prone. Quality problems in this area have the potential to effect PK test results. Processes where data is captured on paper and subsequently transferred into electonic records management system (ERMS) or document management systems have high potential for errors, especially when the data is entered by staff who do not fully understand the data's relevance.

Errors that affect the validity of clinical trials can easily occur when the protocol and procedures are not well known or readily accessible. It is conceivable that a physician, who is treating a number of patients during different Phase 1 clinical trials, is not aware of the protocol for increasing or decreasing a dosage due to an adverse effect. The physician's actions or lack thereof, if not in compliance with the study protocol, may have a serious effect on the data and the clinical trials results.

However, in P-Wave 21 CFR Part 11 validated solutions such as LabCORE, a participating Phase 1 clinical trial physician may have been prompted by the ERMS to read and sign the protocol or the SOP for that particular clinical trial. The pysician's actions would be logged as part of the audit trail and potentially flagged by the system with notification sent to the appropriate managers for review. The bottom line is that the data and related documentation captured and archived in an ERMS can help enforce process consistency and provide the FDA with more confidence in the efficacy of the results.

The eCTD is a complex document that can be daunting to create and manage, especially manually or by assembling the required documents and data from mixed paper and electronic sources. It can be nearly impossible to ensure the use of the correct and current versions of documents and data by manual or partially automated methods.

P-Wave LabCORE product can organize the information into the required eCTD folder structure. LabCORE can automate the conversion of documents from a variety of formats to PDF or other formats required by the eCTD and generate the XML backbone for the eCTD. Automating the eCTD process will greatly improve the lifecycle management of the eCTD. LabCORE will track modifications and versions of documents and data to facilitate the management of resubmissions.

Contact P-Wave and we will describe the process of managing documents and data and creating and managing an eCTD, within the context of the LabCORE Document Management System which is specifically designed for use by CRO's and life Science laboratories.

See more at www.lab-core.com