Systems Architecture

Introduction

Pharmaceutical, biotech and medical device companies require advanced systems to support the clinical trial process in today’s competitive market. Fountayn provides a complete and innovative systems architecture for the global clinical trials industry. Our extensive systems infrastructure is built upon industry-leading technology designed to securely deliver enterprise applications, provide superior performance and maximize application uptime.

N-Tier Architecture

We utilize N-tier architectural design that enables you to distribute functionality across computer resources. Distributed workload allows using available resources more effectively. The architecture consists of the following tiers: User Interface Tier, Application Server Tier and Data Tier with physical separation between each tier and logical separation between each layer. The Data Tier stores your enterprise data in a relational database or on the file server. Application Server Tier enables users to access data and functionality, provides logical security, and controls data validation and analysis. The User Interface tier consists of the end user's desktop web browser and allows access to our applications from anywhere in the world over the Internet. The User Interface tier utilizes the latest web interface technologies to provide a flexible and adjustable view that is tailored to the user's needs and workflow. Our Application Server Tier is powered by the Apache Tomcat Application Server. The Apache Tomcat Application Server, a key component of this infrastructure, offers the industry's most comprehensive solution for developing, integrating and deploying enterprise applications using Open Source products. Our Relational Database is powered by Oracle Database to meet our performance, high availability and reliability requirements.

Availability, Scalability, Redundancy & Performance

Fountayn has been designed to be highly available. This design includes redundancy and fault tolerance of the entire platform stack, including network, security and server infrastructure. Fountayn is using SOC 2 Type 2 data center with infrastructure designed to be highly available. Our data center design includes robust power backed up by largest diesel generators in the region and refueling priority status, power monitoring, climate control and BGP dedicated Internet access for high Internet availability with multiple upstream providers.

Our rationale follows (n+ 1) redundancy model where 'n' equals the number of components necessary plus one. This model provides high availability and redundancy in every layer of our design and ensures maximum performance and application uptime in the event we experience a single component failure. A powerful advantage of our systems architecture is that each component in the design is clustered to support maximum scalability and availability. A cluster is defined as two or more computing devices working together for a common purpose. As our customers grow and the user workload increases, we can scale with our customers by adding Internet bandwidth, application servers and database servers seamlessly into our environment.

Our application server tier is fronted by a traffic management appliance powered by F5 Load Balancers with centralized certificate management, central restriction of weak SSL ciphers and advanced compression engine. Load balancers, when integrated into our systems architecture, allows us to load balance traffic to our entire application server cluster securely, and with an ensured quality of service.

Our data tier is back-ended by a storage area network (SAN) solution. We utilize a flash storage array with 256-bit AES inline encryption for the data-at-rest. Self-encryption drives provide encryption without sacrificing performance. Oracle Automatic Storage Management (ASM) is used for administering space usage on SAN. Oracle ASM is a volume manager and a file system for Oracle database files that supports our Oracle Real Application Clusters (Oracle RAC) configurations to achieve maximum performance and ability to grow on-the-fly. Oracle Database RAC software provides continued operation of applications and databases in the event of a server failure. This creates an extraordinarily high availability database environment, balances workloads across multiple database servers and allows unprecedented levels of scalability. We deploy our Oracle Database RAC software on 64-bit server hardware and 64-bit Linux operating systems. Our database server infrastructure is positioned to deliver security, scalability and a high performance experience. Each server in our infrastructure has a redundant network access, redundant power supplies and Redundant Array of Independent Disks (RAID).

Data Security

Rest assured knowing that the Fountayn platform is monitored on a 24x7 basis. Information data security has changed radically in the last decade, and is more important today than it has ever been in the past. A security breach has the potential to impact a business's bottom line; damaging its reputation, customer loyalty and profitability. We are employing a layered approach to protect our systems from Physical security to Administrative security. Our system's data architecture offers an innovative and secure data design by segregating and organizing customer data. Our secure network includes state-of-the-art systems for both physical and logical security. The first step in maintaining a secure environment is preventing unauthorized access to the data center and Fountayn facilities. To this end, both our SOC 2 Type 2 production and disaster recovery data centers are physically secured with multi-factor authentication including, but not limited to: key card access to authorized personal only, 24x7x365 video surveillance and trained 24x7 on-site guards to provide additional protection against unauthorized entry and access logs.

We have protected our production perimeter network with redundant intrusion prevention and detection systems (IPDS) and redundant firewalls providing ongoing protection from exploits and to block unauthorized system access. Our IPDS units managed and monitored 24x7 with at least daily or more often signatures update to provide continuous threat intelligence. Network Security is also controlled with network segmentation, regularly scheduled vulnerability audits, network event logging and system patching to prevent misuse or modification of network-accessible resources.

To ensure the security of our transactions we are enforcing 128-bit or higher encryption. To guarantee that a client receives this level of protection, we require that the client uses a browser that supports 128-bit encryption with our production applications. Our servers also enforce strong ciphers to protect the integrity of data exchange with centralized certificate and ciphers management. To further strengthen our security, we ensure that all employees are trained on documented information security and privacy procedures, follow secure document and media destruction policies and follow other documented management procedures.

Disaster Recovery

Fountayn has established and maintains processes and/or procedures aimed at allowing the company to continue functioning during a Disaster, rather than simply being able to recover after a Disaster. Fountayn's Business Continuity plan addresses Planning, Assessment, Prevention, and Procedure. Fountayn maintains the Disaster Recovery host-site with close to a real-time database data replication and Recovery Point Objective of 15 minutes or less, with a regular testing program established and executed.

Backup & Recovery

While High Availability Design and Disaster Recovery are the primary means to recover data and restore service in the case of a service disruption, in certain cases it is desirable to use more traditional data backup and recovery mechanism. We keep three weeks of daily backups on-site at the primary datacenter for fast recovery if necessary and send month-end backups to the secure off-site location. All backup tapes are encrypted with 256-bit AES encryption with centralized key management. Backup data are completely protected in transit or at rest and stored off-site at the highly protected facilities and offer increased protection from high flood, earthquake, or disaster risk with an ability to retrieve it when necessary at any time.

Conclusion

We offer a systems architecture that provides secure, reliable, high-performance systems for the clinical trial process. Our goal is to provide the most efficient, stable and successful experience possible throughout the life cycle of clinical research.

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