CRANFORD, NEW JERSEY – October 17, 2016 – Paragon Solutions, a leading advisory consulting and systems integration firm specializing in the life sciences industry, announced the successful completion of a large-scale implementation and deployment of Vault eTMF for a Top 20 Global Pharmaceutical Company.
The client needed a true client partner consulting partner that could provide end-to-end full services including, but not limited to, vendor identification acceleration, future state processes building and enablement, systems integration, document and data migration, change management, organizational design and training and implementation.
“Our client wanted to ensure that they were fully satisfying the requirements of Global Health Authorities” said James O’Keefe, Vice President of Paragon’s R&D Consulting Practice for Life Sciences. “After a thorough assessment, we realized the need to drive a more active management of TMF documents, to ensure completeness and compliance in flight of studies instead of at study close. There was also a clear need to harmonize and codify business processes, further define requirements and select a COTS vendor to support the future state of the eTMF.”
Based on the depth of Paragon’s knowledge of the COTS vendor landscape, and to ensure timely selection of a vendor aligned to the vision and requirements of the client, Veeva’s Vault eTMF solution was chosen. After vendor selection, Paragon Solutions was responsible for the overall program implementation, coordination and partnership with Veeva services, the clients internal middleware and integrated systems team, and provided the services of program management, test leadership, solution design, implementation planning and change management, requirements management and communications execution.
As a result, the client ended up with a fully implemented Vault eTMF system, with a pilot phase scope encompassing integrations with 6 systems to over 200 users and 7 studies. The full implementation included migration of over 8 million records from legacy eTMF to Vault. In September 2016, the clients eTMF solution launched successfully for all active studies with complete CRO Enablement leveraging the clients Vault eTMF across all strategic CRO partners.
“Paragon’s deep domain expertise and technical experience helps us identify and remain focused on client challenges,” said O’Keefe. “This project represents another great example of how Paragon is an invested client partner, and how our focus on outcome-based delivery drives greater business value and commitment to our clients’ long-term success.”
About Paragon Life Sciences Consulting Services
A practice domain of Paragon Solutions, Paragon Life Sciences expertise and solutions include clinical optimization, commercial consulting, corporate and enterprise solutions, quality and manufacturing services and regulatory optimization strategy and services. Paragon’s Life Sciences practice stems from decades of experience across the Life Sciences industry, resulting in a team with deep industry thought leadership that provide practical solutions to client problems by leveraging technologies from various technology partners.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.
Paragon works with businesses that are focused in a few key industries − communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management and Information Integration. For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582. On social media, visit Paragon on Twitter @consultparagon or Paragon Solutions on LinkedIn and follow updates from Paragon on Facebook.