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                                                                                                                  intelligence

     trial                         site                         patient
   intelligence                  intelligence                  intelligence




Wo r l d - C l a s s H o s t i n g S e r v i c e
t H e m e r g e e c l i n i c a l a d va n ta g e
Merge eClinical’s application hosting services go beyond standard hosting
                                                                                      merge eclinical’s highly robust
by providing a holistic solution to essential business continuity, resiliency
and security. Merge eClinical has invested heavily to help you attain the
                                                                                      hosting services help ensure:
peak performance your trials need to always be running quickly, efficiently          • Trial downtime is mitigated with
and in a security-rich and industry-compliant environment.                             state-of-the-art disaster recovery
                                                                                       systems
Recognizing your critical need to access trial data at any time and in
virtually any location around the world, Merge eClinical has assembled a             • Critical systems, IT processes and
highly talented team of IT professionals. Having successfully                          networks are highly available
implemented more than a thousand trials, you can rely on our proven
                                                                                     • Service levels are guaranteed across
experience and certified technical knowledge to support your trial
environments.                                                                          applications and operating
                                                                                       environments
Managed by Peak10, a recognized leader in IT site services, our data               • Business risk is greatly reduced due
center facility is able to ensure the network is highly available, reliable,
                                                                                      to unanticipated events
redundant and secure. The data center is fitted with the latest hardware
and software platform technology, disaster recovery and is configured for
scalability. Merge eClinical manages your eClinical platform and
applications to ensure consistent and reliable performance, while maintaining operations under virtually any condition.

HoSting infraStructure
Merge eClinical houses study data in a secure, state-of-the-art hosting center and includes:
• Superior service level agreements
• High-performance connectivity
• Redundant network and disaster recovery measures for high availability
• A rich set of security services

Service Level Guarantee
Merge eClinical provides a Service Level guarantee that the system will be available to users in excess of 99% of the time. Due to the
nature of most client activities, it is understood that the system often needs to be operational outside of regular business hours. The
production server environment does not require system shutdown for daily data back-up, and with the exception of short periods for
scheduled maintenance (conducted overnight on weekends) the system will be available on a 24/7 basis.

Data Protection
Continuous data protection is achieved with a powerful EMC SAN. Advanced storage capabilities include simple management tools,
continuous data availability and integrity, high performance data mobility and scalability. Additionally, Merge eClinical utilizes local
replication for backup/restore and remote replication for disaster recovery and data mobility.
Security
Physical security
Production & disaster recovery data centers
The data center restricts and monitors access using the following methods:
 • 24/7 onsite security personnel                     •       Proximity card access throughout the facility
 • Client security escort                             •       Access is restricted to authorized personnel
 • Electronic motion detectors                        •       There is a fire suppression system in place
 • Continuous video camera surveillance               •       Reinforced exterior and interior walls
 • Unified security breach alarm with                 •       Raised floors for secure cable routing
   access monitoring                                  •       Temperature and water sensors
 • Biometric fingerprint scan identification system

 Merge eClinical headquarters
 The following are high level security features at the physical location of our headquarters office:
 • Access is restricted to authorized personnel        • Break glass monitoring system
 • Proximity card access throughout the facility       • 24/7/365 badge access monitoring system
 • Motion detection system                             • Fire suppression system
 • Defcon Halogen units located in secured areas • Master key access for only senior management
 • 24/7/365 badge access monitoring system               team members

Network Security
 • Redundant firewalls with IPS (Intrusion            • State-of-the-art VPN connection between our
   Prevention Systems), protecting the                  wireless ISP and the production network
   infrastructure from internal or external attacks     provides secure data transmissions between
 • Data transfer between clients and Merge              our diary devices and the servers
   eClinical is over the Internet, operating on       • Secure SSL/TSL encryption at the mail
   secure port https                                    gateway
 • Firewall controls inbound and outbound             • Security-rich process for managing account
   access to Merge eClinical equipment and is           generation, maintenance and termination for
   only enabled through designated ports                maintenance, as well as user accounts
 • Hardened router configurations                     • Administrative access to Merge eClinical
 • Anti-virus protection                                systems are limited and based on group
 • Secure File Transfers via public SSH server          membership

Host Security
 • Patches are applied to Merge eClinical                 •   System access logs are local to the systems
   systems as available and after thorough                •   Access limited to certain IP address ranges
   assessment                                             •   All privileged use is logged
 • Administrative access to Merge eClinical               •   Security-related events are logged and
   systems is limited and based on group                      reviewed daily, including:
   membership                                                 o User login failures
 • Merge eClinical systems are administered                   o Failure to obtain privileged access
   remotely                                                   o Access policy violations
 • Utilization of Windows® terminal services                  o Administration events
   client                                                     o Access policy modifications

Antivirus Policy
 • McAfee® Virus Scan Enterprise anti-virus solution
 • All devices placed on the network system are patched prior to initial connection
 • Virus definitions are updated daily via automatic updates

Incident response policy
  Internal employees are trained on procedures for reporting security incidents
arcHitecture
Network
Merge eClinical has invested more than $1M U.S in its new network
infrastructure. High availability is achieved through the use of
redundant firewalls at the network gateway and high-end core
switches internally. Network security is enhanced by the use of an
IPS at the network gateway.

Production Application/Database
Merge eClinical utilizes a three-tier high availability design for its
application and database hosting:
• Tier one are the application servers, which utilize blade servers
   for their compact design, speed, and ease of expansion.
• Tier two is a database cluster which provides high availability and
   scalability of the database.
• Tier three is a SAN (Storage Area Network) which houses the
   databases and provides speed, high availability, scalability,
   redundancy and security.
                                                                                                                Reliability
reliability                                Reliability
                                                                                                                         Server hardware
                                                                                                                         etrials uses only high-end IBM
Server Hardware                                      Server hardware
                                                                                                                         achieve full redundancy with re
                                                     etrials uses only high-end IBM and Dell servers to host all client applications. Servers
Merge eClinical uses only high-end IBM and Dell servers to host all client applications. Servers
                                                     achieve full redundancy with redundant power supplies, processors, network mirrored operatin
                                                                                                                         connections,
achieve full redundancy with redundant power supplies, processors, network connections, mirrored RAID-5 data storage.
                                                     connections, mirrored operating system drives and
operating system drives and RAID-5 data storage.                                                                         Data center
                                                     Data center                                                         The following are reliability fea
                                                     The following are reliability features of the physical data center:          Redundant air conditio
Data Center                                                   Redundant air conditioning systems                                  Raised floor designed
The following are reliability features of the physical data center: floor designed for efficient cooling
                                                              Raised                                                              Static transfer switche
• Redundant air conditioning systems                     • Certifiedtransfer switches and fully redundant UPS
                                                              Static technical staff onsite 24/7                                  Backup diesel genera
                                                              Backup diesel generator entrances                                   State-of-the-art netwo
• Raised floor designed for efficient cooling            • Redundant and diverse fiber
                                                              State-of-the-art network operations center                          Certified technical staf
• Backup diesel generator                                • Multi-homed Internet backbone with DS-3,                               Redundant and divers
                                                              Certified technical staff onsite 24/7
• Static transfer switches and fully                        OC-3 and Gigabit diverse fiber entrances
                                                              Redundant and Ethernet connections                                  Multi-homed Internet b
  redundant UPS                                             using BGP-4 routing protocol
                                                              Multi-homed Internet backbone with DS-3, OC-3 and Gigabit Ethernet  connections using BG
• State-of-the-art network operations center                  connections using BGP-4 routing protocol




                                                                                                                                                4
t e l e c o m m u n i c at i o n S
Merge eClinical telecommunications vendors are required to maintain redundant systems in the event
of a failure.


Advanced Phone System
Merge eClinical uses an IP phone system that enables locations to be connected 24/7/365. The
phone system can be used as a disaster recovery process when phones are programmed in the
teleworker mode in the event of an emergency.

Automatic Call Dialer (ACD) System
The Merge eClinical ACD system is state-of-the-art and enables our helpdesk staff to quickly,
efficiently and knowledgably aid in the handling of any issues that may occur while assisting our
clients. Report generation can be obtained through this system for all calls entering the ACD network.

Fax Server
Merge eClinical uses a robust fax server for all external/internal faxing.


S ta n d a r d o p e r at i n g p r o c e d u r e S
Merge eClinical follows a very detailed set of operating procedures to ensure the security and
confidentiality of information. The procedures also identify hiring and training methods, project
design and control, quality control and customer support.




Call today 866.387.4257 or visit www.merge.com/eclinical
Merge Healthcare utilizes decades of technology, expertise, intellectual property, innovative software development and expert services to build IT solutions for
healthcare and biopharmaceutical customers worldwide. We bring a customer-driven enthusiasm that assures etrials Service Delivery remains relevant to your
business goals, now and into the future. Copyright 2009 Merge Healthcare Incorporated.

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World-class Hosting Services

  • 2. synchronized intelligence trial site patient intelligence intelligence intelligence Wo r l d - C l a s s H o s t i n g S e r v i c e t H e m e r g e e c l i n i c a l a d va n ta g e Merge eClinical’s application hosting services go beyond standard hosting merge eclinical’s highly robust by providing a holistic solution to essential business continuity, resiliency and security. Merge eClinical has invested heavily to help you attain the hosting services help ensure: peak performance your trials need to always be running quickly, efficiently • Trial downtime is mitigated with and in a security-rich and industry-compliant environment. state-of-the-art disaster recovery systems Recognizing your critical need to access trial data at any time and in virtually any location around the world, Merge eClinical has assembled a • Critical systems, IT processes and highly talented team of IT professionals. Having successfully networks are highly available implemented more than a thousand trials, you can rely on our proven • Service levels are guaranteed across experience and certified technical knowledge to support your trial environments. applications and operating environments Managed by Peak10, a recognized leader in IT site services, our data • Business risk is greatly reduced due center facility is able to ensure the network is highly available, reliable, to unanticipated events redundant and secure. The data center is fitted with the latest hardware and software platform technology, disaster recovery and is configured for scalability. Merge eClinical manages your eClinical platform and applications to ensure consistent and reliable performance, while maintaining operations under virtually any condition. HoSting infraStructure Merge eClinical houses study data in a secure, state-of-the-art hosting center and includes: • Superior service level agreements • High-performance connectivity • Redundant network and disaster recovery measures for high availability • A rich set of security services Service Level Guarantee Merge eClinical provides a Service Level guarantee that the system will be available to users in excess of 99% of the time. Due to the nature of most client activities, it is understood that the system often needs to be operational outside of regular business hours. The production server environment does not require system shutdown for daily data back-up, and with the exception of short periods for scheduled maintenance (conducted overnight on weekends) the system will be available on a 24/7 basis. Data Protection Continuous data protection is achieved with a powerful EMC SAN. Advanced storage capabilities include simple management tools, continuous data availability and integrity, high performance data mobility and scalability. Additionally, Merge eClinical utilizes local replication for backup/restore and remote replication for disaster recovery and data mobility.
  • 3. Security Physical security Production & disaster recovery data centers The data center restricts and monitors access using the following methods: • 24/7 onsite security personnel • Proximity card access throughout the facility • Client security escort • Access is restricted to authorized personnel • Electronic motion detectors • There is a fire suppression system in place • Continuous video camera surveillance • Reinforced exterior and interior walls • Unified security breach alarm with • Raised floors for secure cable routing access monitoring • Temperature and water sensors • Biometric fingerprint scan identification system Merge eClinical headquarters The following are high level security features at the physical location of our headquarters office: • Access is restricted to authorized personnel • Break glass monitoring system • Proximity card access throughout the facility • 24/7/365 badge access monitoring system • Motion detection system • Fire suppression system • Defcon Halogen units located in secured areas • Master key access for only senior management • 24/7/365 badge access monitoring system team members Network Security • Redundant firewalls with IPS (Intrusion • State-of-the-art VPN connection between our Prevention Systems), protecting the wireless ISP and the production network infrastructure from internal or external attacks provides secure data transmissions between • Data transfer between clients and Merge our diary devices and the servers eClinical is over the Internet, operating on • Secure SSL/TSL encryption at the mail secure port https gateway • Firewall controls inbound and outbound • Security-rich process for managing account access to Merge eClinical equipment and is generation, maintenance and termination for only enabled through designated ports maintenance, as well as user accounts • Hardened router configurations • Administrative access to Merge eClinical • Anti-virus protection systems are limited and based on group • Secure File Transfers via public SSH server membership Host Security • Patches are applied to Merge eClinical • System access logs are local to the systems systems as available and after thorough • Access limited to certain IP address ranges assessment • All privileged use is logged • Administrative access to Merge eClinical • Security-related events are logged and systems is limited and based on group reviewed daily, including: membership o User login failures • Merge eClinical systems are administered o Failure to obtain privileged access remotely o Access policy violations • Utilization of Windows® terminal services o Administration events client o Access policy modifications Antivirus Policy • McAfee® Virus Scan Enterprise anti-virus solution • All devices placed on the network system are patched prior to initial connection • Virus definitions are updated daily via automatic updates Incident response policy Internal employees are trained on procedures for reporting security incidents
  • 4. arcHitecture Network Merge eClinical has invested more than $1M U.S in its new network infrastructure. High availability is achieved through the use of redundant firewalls at the network gateway and high-end core switches internally. Network security is enhanced by the use of an IPS at the network gateway. Production Application/Database Merge eClinical utilizes a three-tier high availability design for its application and database hosting: • Tier one are the application servers, which utilize blade servers for their compact design, speed, and ease of expansion. • Tier two is a database cluster which provides high availability and scalability of the database. • Tier three is a SAN (Storage Area Network) which houses the databases and provides speed, high availability, scalability, redundancy and security. Reliability reliability Reliability Server hardware etrials uses only high-end IBM Server Hardware Server hardware achieve full redundancy with re etrials uses only high-end IBM and Dell servers to host all client applications. Servers Merge eClinical uses only high-end IBM and Dell servers to host all client applications. Servers achieve full redundancy with redundant power supplies, processors, network mirrored operatin connections, achieve full redundancy with redundant power supplies, processors, network connections, mirrored RAID-5 data storage. connections, mirrored operating system drives and operating system drives and RAID-5 data storage. Data center Data center The following are reliability fea The following are reliability features of the physical data center: Redundant air conditio Data Center Redundant air conditioning systems Raised floor designed The following are reliability features of the physical data center: floor designed for efficient cooling Raised Static transfer switche • Redundant air conditioning systems • Certifiedtransfer switches and fully redundant UPS Static technical staff onsite 24/7 Backup diesel genera Backup diesel generator entrances State-of-the-art netwo • Raised floor designed for efficient cooling • Redundant and diverse fiber State-of-the-art network operations center Certified technical staf • Backup diesel generator • Multi-homed Internet backbone with DS-3, Redundant and divers Certified technical staff onsite 24/7 • Static transfer switches and fully OC-3 and Gigabit diverse fiber entrances Redundant and Ethernet connections Multi-homed Internet b redundant UPS using BGP-4 routing protocol Multi-homed Internet backbone with DS-3, OC-3 and Gigabit Ethernet connections using BG • State-of-the-art network operations center connections using BGP-4 routing protocol 4
  • 5. t e l e c o m m u n i c at i o n S Merge eClinical telecommunications vendors are required to maintain redundant systems in the event of a failure. Advanced Phone System Merge eClinical uses an IP phone system that enables locations to be connected 24/7/365. The phone system can be used as a disaster recovery process when phones are programmed in the teleworker mode in the event of an emergency. Automatic Call Dialer (ACD) System The Merge eClinical ACD system is state-of-the-art and enables our helpdesk staff to quickly, efficiently and knowledgably aid in the handling of any issues that may occur while assisting our clients. Report generation can be obtained through this system for all calls entering the ACD network. Fax Server Merge eClinical uses a robust fax server for all external/internal faxing. S ta n d a r d o p e r at i n g p r o c e d u r e S Merge eClinical follows a very detailed set of operating procedures to ensure the security and confidentiality of information. The procedures also identify hiring and training methods, project design and control, quality control and customer support. Call today 866.387.4257 or visit www.merge.com/eclinical Merge Healthcare utilizes decades of technology, expertise, intellectual property, innovative software development and expert services to build IT solutions for healthcare and biopharmaceutical customers worldwide. We bring a customer-driven enthusiasm that assures etrials Service Delivery remains relevant to your business goals, now and into the future. Copyright 2009 Merge Healthcare Incorporated.