Immunomedics adopts PleaseReview to accelerate documentation management

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/nirat)
(Image: Getty/nirat)

Related tags: Data management, Immunomedics, antibody-drug conjugates, Antibody drug conjugates, Antibody, Data, Software, Clinical data, Clinical data management, Fda

Immunomedics to leverage Ideagen’s PleaseReview software service to support documentation management of its ADC development projects.

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.

Related topics: Clinical Development, Data management

Related news

Show more

Related products

show more

Overcoming Challenges of Clinical Data Review

Overcoming Challenges of Clinical Data Review

PerkinElmer | 10-Jun-2021 | Technical / White Paper

Clinical data review is intrinsic to clinical development, assuring patient safety, determining drug efficacy, and assessing data quality. It involves...

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 09-Jun-2021 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Related suppliers

Follow us


View more