The alliance partner provides a low-code automation platform that accelerates the creation of high-impact business applications. Many of KPMG's biggest clients and some of the world's largest organizations use the alliance partners applications to improve customer experience, to achieve operational excellence, and simplify global risk management.
A global Contract Research Organization (CRO), handling some of the most complex clinical drug trials, struggled with ensuring compliance and quality control over regulatory information across ever-changing global requirements. In addition to being able to maintain the required level of control, they had difficulty producing audit trails for their processes. Additionally, local and regional interpretations and assessments of regulatory requirements were collected locally and not in a global centralized repository, so that capturing and memorializing this critical knowledge proved challenging.
Their dispersed subject matter expertise needed to be better coordinated, but they lacked a means to organize and consolidate their scattered data sources and disparate procedures.
The organization sought a solution that could bring together and organize regulatory intelligence and requirements data from their operational Regulatory Intelligence Units (RIU’s). This included being able to sort and add a taxonomy for information on product lifecycle, safety, regulatory affairs, and medical affairs.
They additionally wanted to give end users the ability to customize how data would be viewed, validated, and updated within the RID system, without the need to bring in a software developer and systems integrator each time.
With the platform, the company was able to digitally transform their processes to:
• Allow all end-users to have access to all content, while managing content ownership and edit capabilities based on user role and permissions
• Create multiple flexible change request processes and consolidate data into unified procedures
• Establish the flexibility to generate reports on any data within the system
• Provide a single, secure place for personnel to see the status of all Regulatory Intelligence activities
• Create a system for managing key regulatory form templates, latest regulations and documents by location
• Produce reports to assure that procedures such as validation approvals, process checklists, and fully reportable audit trails are being followed