L I F E S C I E N C E S S O L U T I O N S SharePoint Based Clinical Architecture

Delivering Clinical Architecture that Supports

Clinical Trial Management

Paragon Solutions is an advisory consulting and systems integration firm that specializes in life sciences solutions across the pharmaceutical, biotechnology, and medical device industries.

Paragon defines clinical architecture as the ecosystem of system features, capabilities and data that support the overall business processes for clinical trial management. We follow a series of guiding principles and best practices in our implementations that when accounted for, will result in a more efficient, manageable and maintainable clinical architecture for your organization. Some of these include:

` Definition of user communities and the information they require to support their business processes.

` Single Source/Version of the Truth – To maintain a high level of information quality, it is critical to define the single source and/or version of the truth for a given piece of information.

` User Stories – Define what information users need, which systems and business processes they have heavy interaction with, and determine the most efficient and cost effective way to provide that information.

Defining Your Clinical ArchitectureThe clinical operations systems landscape is evolving and maturing at a rapid rate, as the business processes, health authority requirements, and pressures to become more efficient also mature and evolve. The landscape includes a large variety of system capabilities and vendors, which continue to push the feature sets they support for a given user role or business process. Where once there was just Clinical Trial Management Systems (CTMS), Clinical Data Management Systems (CDMS) and Electronic Data Capture (EDC), now there are a host of capabilities such as electronic Trial Master Files (eTMF), external collaboration/investigator portals, interactive voice response systems (IVRS) and electronic patient reported outcomes (ePRO) systems to assess and integrate into the larger clinical architecture and capabilities.

Copyright ©2012 n Paragon Solutions is a registered trademark of Paragon Solutions, Inc. n SCA-PBN/04-12

About Paragon

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’s Life Sciences practice addresses the needs of thepharmaceutical, biotechnology, and medical device sectors.Our technology solutions are helping firms respond andcapitalize on industry change driven by competition,consolidation, convergence and regulation.

For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582, ext. 3043.

About BioClinica

BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management services. BioClinica supports pharmaceutical and medical device innovation with imaging core lab, internet image transport, electronic data capture, interactive voice and web response, Microsoft Office-Smart clinical trial management, and clinical supply chain forecasting and optimization solutions. BioClinica services maximize efficiency and manageability throughout all phases of the clinical trial process. With more than 20 years of experience and over 2,000 successful trials to date, BioClinica has supported the clinical development of many new medicines from early phase trials through final approval. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide eClinical and data management services from offices in the United States, Europe and Asia. For more information, please visit www.bioclinica.com.

About NextDocs

NextDocs is the global leader in providing Microsoft SharePoint-based compliance software solutions including quality management software, regulatory document management, and clinical portals. Our solutions enable businesses in regulated industries to achieve compliance with FDA and other agencies while automating processes, improving efficiency, and dramatically reducing costs. NextDocs customers include pharmaceutical companies, bio-techs, medical device companies, and CROs. For more information on NextDocs Corporation and its software solutions visit www.nextdocs.com.

SharePoint Based Clinical Architecture

Alliance partners Paragon Solutions, BioClinica and NextDocs have jointly developed SharePoint based Clinical Reference Architecture to address document management and operational data management across all clinical trials. By leveraging SharePoint as the platform, this solution simplifies the consolidation and integration of operational data from and between CTMS, EDC, IVRS, eTMF and clinical portals to offer a cost-effective, unified study management environment.

NextDocs

NextDocs’ collaborative solution for clinical trials, helps our clients transform their operations by streamlining processes, automating information exchange, and reducing administrative overhead associated with running clinical trials. The NextDocs Clinical Document Management Solution is comprised of two main components – The Clinical Trial Investigator Portal and Electronic Trial Master File.

BioClinica

BioClinica OnPoint solutions help sponsors of clinical trials and CROs to efficiently access, share, and analyze operational trial data. OnPoint’s tight integration with SharePoint enables users to interact with the system via Microsoft Office applications (Outlook, Excel, Word, etc.), speeding user adoption and compliance. BioClinica OnPoint software fully supports compliance requirements for the US 21 CFR Part 11 Regulation.Interoperability is further enhanced by a standards-based architecture which supports XML-based conventions and CDISC standards.

Paragon Solutions

Paragon’s Life Sciences Clinical Optimization Practice specializes in solutions to help Sponsors and CROs increase operational efficiency, lower costs, improve situational awareness and manage risk. Paragon has the management consulting expertise to assess and develop business cases and capability maturity assessments, model the current state, develop the future state, define an implementable, practical capability roadmap, and deliver solutions that bridge the gap to improve the way work gets done. From strategy to implementation, we work to understand your current state and guide you through a vision for the future.