Last updated on June 23rd, 2023 at 12:28 pm
INTRODUCTION
Clinical Data Management is a critical phase in clinical research that leads to the generation of high quality, reliable and statistically sound, sensitive data from clinical trials. This helps in drastically reducing time from drug development to marketing. There are various team members that are actively involved in the various stages of clinical trial right from inception to its culmination.
They have to deal with and manage vast amounts of data, much of which is highly sensitive and subject to privacy rules. This is where Virtual Data Rooms play a huge role in improving clinical research data management. They offer easier file sharing with valuable advanced features that not only simplify the work flow for the teams, but keep your data highly secure. Since they are virtual cloud-based spaces, authorized users can access it from anywhere in the world using internet connection.
VDRs offer impeccable security to your data both at rest and in transfer using the most secure encryption. Besides it offers multi-factor authentication and advanced security features like watermarks, fence views, granular permissions and audit trails. This protects against cyber-attacks and data breaches.
The purpose of a clinical trial is to find answers to the research questions by means of generating data for proving or disapproving a hypothesis. So the data that is collected needs to be organized and easily accessible. Besides there needs to be minimum number of errors or missing data as possible and gather maximum data high quality for analysis. For these best practices need to be adopted to ensure that the data is complete, reliable and processed correctly.
A proper audit trail has to be maintained, that provides easy identification and resolution of data discrepancies. Besides in clinical trials regulatory authorities mandate compliance with certain protocol specified parameters and requirements. In regulatory submission studies, maintaining an audit trail of data management activities is of utmost importance. VDRs ensure audit trails and help in the management of discrepancies. According to the roles and responsibilities of each team member, multiple user IDs are created, with access permissions and limitations.
This ensures that each user has access to only the respective functionalities allotted to that user Id and cannot make any other change in the data base. For user IDs to whom making changes is permitted the VDR software audit trail will record the change made, the user ID that made the change, the time and date of change. The clinical research and pharmaceutical industries rely heavily on electronically captured data, hence a VDRs validated systems ensures accuracy, reliability and consistency of data with the use of secure, computer generated, time-stamped audit trails that independently record actions that create, modify or delete the data. This ensures the integrity, authenticity and confidentiality of the data and is fully compliant with all regulatory requirements for regulatory evaluations.
Moreover, the teams can also benefit from collaboration tools like notifications, Q& A section, live discussion function that’s basically a live forum for authorized users, finely controllable differential privacy.
All these advanced features of VDRs have made it very popular with the clinical research industry.
The Confiex team specializes in providing premium virtual data room solutions tailored for businesses. With their vast experience in working with document sharing platforms, they have been actively supporting the Virtual Data Room community since 2015 by offering valuable information to users free of charge.