John McNeil, CEO
In excellent electronic trial master file (e-TMF) system is the differentiator between organizations that are competing to pioneer clinical and life science research. For clinical research officers, career opportunities are abundant if they possess the knowledge of e-TMF software. Clinical research organizations are looking for a product that improves the standards of recording clinical trials using various means of technological improvements. Phlexglobal, with an experience of more than 20 years in the field of TMF, has developed its unique range of products and services with an improved and technical approach that plays a crucial role in resolving clinical research issues. Phlexglobal delivers complete, accurate, and consistent solutions from the source of the research to the archive with its very own range of products consisting of PhlexEview and PhlexEarchive, both of which have unique capabilities and features which benefit not only the CRO but every other affiliated entity in the study.
PhlexEview is a customer-driven e-TMF software that functions in real time across all sites of the trial. Built to support CROs and sponsors, PhlexEview is intuitive and has a simplified study setup. While it combines tree and search navigation, it captures study changes, visually identifies missing documents, and provides TMF heat maps to determine the quality of the trial. Its embedded TMF quality review module for oversights and quality management is configurable to the organizations’ standard operating procedures (SOP) and regulatory measures such as good clinical practice (GCP) protocols.
can handle multiple TMF structures to satisfy the demands of various clients
PhlexEview can handle multiple TMF structures to satisfy the demands of various clients. It streamlines the workflow by auto-assigning activities, eliminating multiple communication paths, capturing all relevant information at one place, identifying gaps in the procedure and rectifying them immediately.
On the other hand, PhlexEarchive uses advanced technologies and best practices to ensure content security. This way, firms can avoid any damage to the documents, be it accidental or deliberate. It functions by converting the documents into PDF/A format with the metadata file being in XML format. This way, a standard backbone is created for the documentation and it is ensured that the data is stored securely. Some of the critical features of PhlexEarchive are that it meets all the regulatory requirements, reduces unnecessary IT, while providing 100 percent data integrity. It also offers 24-hour document retrieval and secures the documents by creating three copies of the same. Finally, it also provides a very comprehensive data insurance coverage. Phlexglobal provides expertise at any stage of the trial with its vastly experienced team of professionals that has conducted hundreds of TMF reviews over the years.
Phlexglobal also provides TMF heat maps feature, providing a detailed and textual roadmap to better the TMF health and ensure inspection readiness. Phlexglobal’s expert team helps the users to achieve TMF “Health Zone,” which is the balance between the resources, processes, and technology involved in the TMF across the entire organization. Phlexglobal follows the motto of ‘Raise your standard’ and approaches every project, interaction, and opportunity with a strong mindset.