For several years, trends in modern medicine have been shifting towards promising treatments in cell and gene therapy. Backing these innovative treatments is a complex production process that typically involves many more parties than traditional models, leaving many organizations open to risk as the treatments themselves and supporting documentation moves up and down stream. For personalized medicine companies, solutions like the Veeva Vault QualityDocs and RIMS platforms allow for greater control and visibility into the compliance and quality processes.

Founded in 2015, this client is a pre-commercial genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases by curing the underlying cause of the disease. As the client moved toward clinical development and eventual commercialization of innovative gene therapies, they realized the need for new IT systems to support both quality and regulatory document creation and management. Specifically, the client needed to manage expanding content generated by its engineering, facilities, manufacturing, research, product development, regulatory, and quality organizations.

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Currently lacking any centralized content management systems, the client realized that a platform for sustainable growth was critical in this period of development and expansion. After leading a requirements-gathering and vendor selection project, Clarkston worked with this client to implement two Veeva softwares – the Veeva Vault QualityDoc and Veeva RIMS solutions. Clarkston provided oversight and execution of governance document updates, system validation, user training, and cutover.

Primary Objectives

• Establish sustainable and scalable content management and regulatory information management capabilities
• Control the distribution of each system’s data and content, including automated workflows and electronic storage
• Streamline processes around submission organization, and and data included in the application were substantiated by the appropriate documentation
• Reduce inefficiencies in document creation, revision, review, and approval

Resolution

• Provided project management oversight for both implementation phases, guiding the core client team and the external vendor partner, including all cutover activities and ensuring successful go-lives
• Developed and documented new processes to govern electronic record systems
• Validated each of the out-of-the-box Veeva Vault solutions, including documentation of client-specific user requirements and execution of new test scripts
• Produced training materials, job aids, and delivered initial training to ensure business adoption, while empowering the client to perform ongoing training efforts post go-live

For the full details on this project and the resulting benefits, read the full case study below.

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