Built by software developer Ideagen, PleaseReview is an application that aims to simplify co-authoring and reviewing of documents produced for several purposes, including regulatory submissions and clinical data management.
According to Ideagen, the application also enables redaction of documents, in order to assist the users in protecting sensitive information.
US-based pharmaceutical company, Immunomedics, announced it will utilize the software service to support its development projects for candidates in oncology.
Kiyoung Hong, Immunomedics’ director of Regulatory Operations and Publishing, suggested that the adoption of the application is expected to be ‘extremely beneficial’ as the company looks to streamline its operations, adding that documentation review can often be “quite intense and time-consuming, with sometimes up to 50 authors and reviewers involved at any one time.”
Moreover, Hong noted that the company aims to initially use PleaseReview for its regulatory submission documents, however, over time the application will be integrated as the software for document reviews across the organization.
Earlier this year, Immunomedics experienced a regulatory blockage, with the FDA rejecting the biologics license application for its antibody-drug conjugate (ADC), sacituzumab govitecan, and then announcing instances of data integrity breaches and manipulation found during an inspection.