At PMI, our multi-tiered computer platform is a robust mix of servers supporting both paper CRF double-entry and eCDM applications. Both applications are Microsoft-based and very familiar to most computer users. They are built specifically to the requirements of each clinical study.

Our applications are characterized by 21 CFR Part 11 compliance, as well as best practices related to ongoing management of load balancing, bandwidth, and 24/7 availability.

Backup, Redundancy, Security
Our systems are designed to facilitate rapid restoration of data in the unfortunate event of server failure. PMI’s servers are located in a secure, environmentally controlled area within our corporate facility and backed up at an off-site data center. Both facilities utilize standard best practices with respect to data security.

PMI facility
Building card access - controlled during non business hours
Office - card access employees only or controlled login guest pass
Motion detection alarms
Access controlled secure server room
Servers secured in locked cages within server room.
Climate controlled Server room

Off-site backup facility
Remote location facility specifications:
Building 55,000 square feet, single level, raised floor
Designed to Zone 4 earthquake specifications
Onsite Network Operations Center
Accessible 24x7x365

Space
Dedicated locked cage
Conditioned AC power
Clean, continuous power with redundancy and disaster recovery configurations
Ethernet/fiber access to each row of cages
Staging area

Connectivity/Bandwidth
Vendor-neutral bandwidth provider offering a blend of solution to provide connectivity.
Backbone circuits: multiple Gigabit Ethernet, OC12 (620Mbps), and OC48 (2.48Gbps)

Electrical/Power
HVAC, N+1- redundant cooling system
N+1 redundant power
Back-up batteries with 20 year design life
UPS is backed up by 1.25 MW Diesel Generator
UPS output capacity up to 4x375 KVA

Security
Single point of entry
24x7x365 monitoring
On-site security personnel
Remote controlled CCTV
Motion detection alarms
Combination access card/photo ID badges
Cages have combination or key locks

Fire Suppression
Industry leading VESDA system for the detection of smoke and fire
Dual-interlocking pre-action fire suppression system, separated by zones
Fully addressable fire alarm system

Environmental systems
Temperature maintained at 68degrees F
Humidity maintained at 45% to 55%
Status/alarms for temperature, humidity, smoke/particulates
Raised floor and vented cabinets for improved air flow
Dual stage air filtering system
Automatic fail-over

24x7 Network Operations Center
The Network Operations Center is manned with 24x7 on-site security personnel and staffed by engineers who specialize in security, network monitoring, fault monitoring, resolution, and disaster recovery. The entire network is constantly monitored to ensure that the network and equipment are online and available for data transfer.

 

 

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