Shadow is designed to assist medical writers and biometrics teams in the pharmaceutical field to comply with policy 0070 of the European Medicines Agency (EMA) in meeting the requirements for de-identifying clinical trial documents and data.
Tom Kalfas, head of GCE’s Innovative Solutions team, added, “It’s an exciting time for GCE and our clients. The commitment of our executive leadership and a unique combination of industry and software development experts, we have the resourcing, the vision, and the tools to produce innovative products benefitting our clients as well as our own operational support teams. The future is bright, and the path is clear.”
Shadow provides a machine learning component to leverage metadata for the decrease in project time-to-completion. This allows time to focus on results and further development of the client’s strategy repository. With continued use, Shadow’s machine learning engine will learn to recommend applicable rules, thereby making it increasingly more convenient with every use. With a focus on user experience, Shadow offers dual frame displays to the user so they can see “before and after” versions of data and documents as they consider the best approach to de-identifying their data.
GCE Solutions CEO Neha Aggarwal says Shadow will feature notable innovations including an interactive user guide, a customizable workflow component, and the ability to interactively apply and test data and doc strategies. She adds that, “Shadow will pack applications for data and document de-identification and anonymization as well as report generation, with an emphasis on analysis tools to use for determining risk for re-identification and evaluation of impact on data utility.”
As a mid-sized CRO, GCE prides itself on developing innovative solutions to meet clients’ needs. “We have a great sense of integrity,” says Aggarwal, “and we understand that the development of tools such as Shadow will benefit medical writing and biometrics teams industry-wide. It’s just one more way that GCE Solutions is making a difference for our clients and in the lives of patients we serve.” Shadow is available beginning October 4, 2017, with more features and updates coming soon.