1. © Akaza Research, LLC. 2008 : 1 :: 10 Professional open source for clinical research

2. © Akaza Research, LLC. 2008 : 2 :: 10 Table of Contents Section TitleSlide Nos. Professional Open Source for Clinical Research 3 caBIG TM Experience 4 caBIG TM Enterprise Service Network 5-7 About Akaza Research 8 Quality and Compliance 9 Summary & Thank You 10

3. © Akaza Research, LLC. 2008 : 3 :: 10 Professional Open Source for Clinical Research Licensed caBIG TM Enterprise Support Services Akaza Research’s core business is to provide high-quality support, service, training and documentation to enable success with open source technologies used in clinical research.  Training Materials and Services  End User Training  Developer Training  System Administration Training  Deployment Support  Enterprise Installation  System support and maintenance  Integration  Validation

4. © Akaza Research, LLC. 2008 : 4 :: 10 caBIG TM Experience CTMS workspace participant since 2005 Developers for Patient Study Calendar and caAERS. Demonstrated integration of caBIG tools and caBIG compatible applications through open application programming interfaces (APIs).

5. © Akaza Research, LLC. 2008 : 5 :: 10 Enterprise Installation All Enterprise Installs include: Complete install and security configuration Staging & Production Environments Documentation Installation guide, release notes, administrator’s manual, help files Reports Implementation timeline and checklist, hardware and software specifications, customer acceptance plan Remote InstallPre-Configured ServerHosted

6. © Akaza Research, LLC. 2008 : 6 :: 10 Support Packages System AdministrationDeveloper Proactive monitoring (service availability, logs, database, file checks) Application patches Email and phone help desk Online support portal with knowledgebase, training, and other resources Procedures for back-up and restore Ticketing system Direct guaranteed access to experienced caBIG developers Assistance in requirements, systems integration, deployment, database management, configuration management Facilitate access to caBIG Knowledge Centers and development environments, including latest builds, automated testing reports, SVN Developer wiki Ticketing system Ongoing, on-demand assistance post initial training.

7. © Akaza Research, LLC. 2008 : 7 :: 10 Training Suites End-UserSystem Administrator Developer All training course are delivered by experienced instructors and limited to a small class size. We use hands-on exercises, virtual machine-based simulation, and can adopt a “Train-the-trainer” or direct end-user training paradigm

8. © Akaza Research, LLC. 2008 : 8 :: 10 About Akaza Research  Founded 2003  HQ: Cambridge, MA  23 employees  Flagship Product: OpenClinica, open source EDC and clinical data management platform  Team and organization optimized for service and support »Client Services Group »Engineering Group »Quality Assurance Group »Cross-domain project teams assembled to best meet client needs

9. © Akaza Research, LLC. 2008 : 9 :: 10 Quality and Compliance Akaza maintains a quality system designed to comply with ISO 13485:2003 (“Medical devices - Quality management systems - Requirements for regulatory purposes), Good Clinical Practice (GCP) Principles for Computer Systems Validation (CSV), and FDA 21 CFR Part 11 Guidelines Quality Policy We at Akaza Research are committed to:  Providing reliable and innovative software and technology solutions that adds real value in our customers’ clinical trial processes.  Fulfilling all applicable regulatory requirements for our customers.  Fostering a participatory, energetic open source product community that encourages employees and partners to contribute their talents and ideas while developing their futures.  Continually monitoring and improving the quality of our customer interactions.  Establishing quality standards for suppliers, partners, and contractors, including contributors and developers of the open source software technology in our products, and holding them accountable to these standards.

10. © Akaza Research, LLC. 2008 : 10 :: 10 Summary & Thank You! For more information, contact: Cal Collins Co-Founder & Chief Executive Officer ccollins@akazaresearch.com 617-621-8585 x.11 Benjamin Baumann Co-Founder & Director of Bus. Dev. bbaumann@akazaresearch.com 617-621-8585 x.22 Akaza Research, LLC One Kendall Square Building 400 Cambridge, MA 02139 USA www.openclinica.org www.akazaresearch.com