TCD eClinical Solutions Information

PharmaLTX (Pty) Ltd ("PLX") is an eClinical company launched in 2012 to provide EMR & EDC solutions within clinical research, eliminating the problems inherent to paper-based data collection methods. Rather than focusing on electronic case report forms, like typical EDC systems would, our solution stack offers an EDC integrated electronic medical record (EMR) platform which is used to collect all source data related to a clinical trial. Our EMR solution provides cleaner data more quickly by eliminating paper-based data collection – reducing costs and time to market for pharmaceutical and medical device companies. Our solution maintains the workflow of paper while allowing fast, secure transmission of source data via an online interface. Source data is validated at the point of capture and securely transmitted to the chosen back-end data system - whether it being a commercial off the shelf (COTS) product or PLX's in-house validated EDC called Nukleus. Point of capture validation and single data entry dramatically reduce the number of queries from monitors and data management. Furthermore, since there is only one central database of data, monitors can reduce the percentage of source data verification which enabled the concept of risk based monitoring. Our intelligence engine runs on our EMR's real-time database and allows our team of statisticians and data managers to do predictive analytics and enable adaptive clinical trial designs. Our uniquely designed solution allows all the stakeholders within the product development lifecycle to work on a central, cloud-hosted platform sharing the same database. The entire portal is governed using role-based access and has been implemented and built with the FDA's CFR Part 11 regulations and HIPAA privacy laws as foundation.