Benefits of Employing Virtual Data Rooms for Clinical TrialsAuthor: Logan Tanner
Clinical trials require the collection of information from volunteers, which may include confidential personal health records and other sensitive information. Researchers are responsible for ensuring that this data and the results of the trials are not compromised. However, information is now being digitized and sent via email to investors, researchers and licensing companies, with only basic encryption and password protection, and there is a risk of a privacy infringement. Virtual data rooms (VDRs) not only provide the safety features required by clinical trial programs but also offer a variety of other benefits.
VDRs provide a variety of safety features, the most valuable being access control and data encryption. VDRs include a function which allows the owner to limit a user’s access to certain files within the data room. This means that outside parties such as investors or unauthorized employees will not be able to access files or information intended for researchers’ eyes only, such as information that could lead to a volunteer being identified. This feature can be applied to entire groups of users at once allowing for ease of use for the owner. Another benefit of this feature is that access can be revoked at any time, allowing companies to protect their data from parties no longer involved in the project and an audit of who accessed certain files and what they did with them is kept to maintain control of the data room.
The data encryption services mentioned before are essential as medical information is being targeted by hackers more and more. Unlike credit cards, which can be canceled and replaced, medical data is permanent. Data encryption also protects valuable information such as research and information regarding the development of new drugs or equipment from competitors.
Other safety features include multi-factor verification systems, personally-identifiable watermarks, virus scanning and a “fence view” option. There is also an option that allows the administration of the virtual data room to control what users can do with the data that they have access to. For example, you can prevent the copying, downloading and printing of certain documents to ensure they are not leaked. However, the leaking of photos of documents still poses a security risk. This is where personal watermarks become important because each user has a unique watermark which would allow a company to identify where a leak originated so the necessary legal action against the person or party who leaked the information can be taken. Clinical trials involve volunteers’ personal and medical information. If this information is leaked, legal action may be taken against the company conducting the trials so these features are particularly important.
Clinical trials involve large amounts of data which is conventionally stored in on-site physical data rooms. Virtual data rooms have numerous features which make them favorable over physical data rooms. Bulk uploading saves time by allowing many files to be added to and organized into folders within the data room. They also have a search function, allowing files to be found and accessed quickly rather than having to search through the mountains of papers in physical data rooms. The use of virtual data rooms can also mitigate many of the costs associated with on-site data storage. This is due to there being no need for security monitoring, as well as not needing to print, copy, or transport the data.
Virtual data rooms also have an advantage over physical data rooms because they can be accessed remotely, allowing users all over the world to simultaneously access and review information. Another service offered by some VDRs is a Q&A section, which allows users to not only view documents but engage in discussions pertaining to them. This is particularly important for multi-regional companies who have trials and researchers operating in different regions or countries. It allows them to engage in discussions and analyze the results over different time zones. VDRs are particularly useful during the approval or licensing of a drug as they allow authorities all over the world to simultaneously perform the necessary due diligence required for approval. VDRs can also speed up the entire process because of the organizational tools they offer. A previously laborious and slow process can now be completed in a fraction of the time.