Aris Global Service Overview. agondemand. Software-as-a-Service Solution for Business-Critical and Regulated Life Science Applications

Transcription

1 Aris Global Service Overview agondemand Software-as-a-Service Solution for Business-Critical and Regulated Life Science Applications

2 Copyright 2011 Aris Global. All rights reserved. SO_OD0811 No part of this document may be reproduced or transmitted in any form or for any purpose without the express permission of Aris Global. Aris Global further does not warrant the accuracy or completeness of the information, text, graphics, links or other items contained within these materials. Aris Global shall not be liable for any special, indirect, incidental, or consequential damages, including without limitation, lost revenues or lost profits, which may result from the use of these materials. The information in this documentation is subject to change without notice and does not represent a commitment on the part of Aris Global in the future. Aris Global is a registered trademark and Total Safety, Total Clinical, ARISg, ARISj, agxchange, agsignals, agcomposer, aginquirer, agencoder, agcapture, agclinical, agondemand, agclinical NW, and Register are trademarks of Aris Global. Other products mentioned herein are registered trademark or trademarks of their respective owners. Page 2 Aris Global Service Overview

3 CONTENTS EXECUTIVE SUMMARY 4 WHY SAAS MAKES SENSE FOR THE LIFE SCIENCE INDUSTRY 5 agondemand - THE LEADING SAAS SOLUTION FOR LIFE SCIENCES 8 COMPREHENSIVE DATA SECURITY AND CONFIDENTIALITY 9 ASSURED COMPLIANCE 10 HIGH AVAILABILITY AND PERFORMANCE 11 FAIL-SAFE BUSINESS CONTINUITY 12 MULTI-TENANCY AND HIGHLY CONFIGURABLE APPLICATIONS 13 IMMEDIATE AND LONG-TERM BENEFITS 14 ABOUT ARIS GLOBAL 16 agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 3

4 EXECUTIVE SUMMARY In such times, Software-as-a-Services (SaaS) has emerged as a promising delivery platform that can give organizations a reduced total cost of ownership, streamlined processes, better scalability and improved adherence to compliance. Life sciences industry today is going through a tough phase and facing many challenges --patent expiry of blockbuster drugs, generic competition, thinning of research pipelines and diversification into newer, costly areas such as biotechnology and bioinformatics. It is imperative that companies who want to succeed come up with better and more efficient ways of doing business that can give them a market edge. Posed with multiple challenges, both business and IT organizations in the life sciences industry are searching for efficient, more cost-effective yet fail-proof software solutions to fulfill their business and regulatory obligations. In such times, Software-as-a-Services (SaaS) has emerged as a promising delivery platform that can give organizations a reduced total cost of ownership, streamlined processes, better scalability and improved adherence to compliance. Aris Global has been dedicated to offering innovative software solutions for the life sciences industry for more than 25 years. In 2007, we realized the need of managing business applications and supporting IT operations more effectively. We conceptualized and implemented a cloud- based SaaS solution for business-critical and highly regulated applications for our life sciences customers. Our SaaS solution, agondemand is available for all Aris Global products spanning pharmacovigilance and safety, regulatory affairs, clinical research and medical information managements. agondemand has been the chosen delivery platform for more than 50 companies worldwide, including small, mid-size and very large pharmaceutical, biotechnology, medical devices companies and CROs. This white paper provides a solution overview of agondemand and describes its robust features and capabilities that make it the robust, proven SaaS offering chosen by more than 50 customers worldwide and earning a 100% success rate in security audits conducted by more than 200 companies. Page 4 Aris Global Service Overview

5 WHY SAAS MAKES SENSE FOR THE LIFE SCIENCES INDUSTRY The Software-as-a-Service (SaaS) platform has attracted lot of attention from different industries in an endeavor to make their IT operations more efficient, cost effective, scalable on demand, and to free up important organization resources, all to enable companies to focus more on strategic areas that can drive business growth and make them more competitive. keeping current with changing regulatory requirements requires system upgrades that can be complicated, time consuming and costly. With cloud computing, a new world of computing power makes it now possible for any organization to achieve these benefits. Cloud computing is a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction. The SaaS service model helps life science companies overcome a long list of traditional challenges: Economic pressures The life sciences industry thrives on deep research and has data as one of the most important assets that is generated using various technologies throughout the drug development lifecycle. Information technology is the backbone of this industry and is constantly evolving to make business more efficient and effective. Yet in light of economic challenges posed to their organizations, IT departments are under tremendous pressure to cut back on capital expenditure and budgets for maintenance of onsite servers, storage devices, business applications, and backup devices such as tape and optical drives. Limited resources and bandwidth to implement and maintain applications Often, pharma IT must prioritize and choose projects mandated from government regulators, consumers and global competition. The bulk of the costs and effort for installing a new application has very little dependency on the size of the department, size of the database, or the required throughput / number of transactions. As such, small-to-midsize companies have to cautiously decide at what point it makes sense to install their own life science applications, compared with a simpler, lessautomated solution, or an outsourced solution. Staying ahead of constant regulatory changes Regardless of the system pharmacovigilance and safety, regulatory affairs tracking, CTMS, medical information, or others keeping current with changing regulatory requirements requires system upgrades that can be complicated, time consuming and costly. System upgrades often require an upgrade of the underlying infrastructure, the installation and configuration of the new version, training and sometimes the complete revalidation of the entire system. Multiple regulatory authorities Especially for global organizations, meeting the often complicated and complex requirements from different regulatory agencies FDA, EMA, MHLW and others can be a challenge that consumes vast amounts of time, effort and resources. Companies need to be ready with systems that enable users to securely exchange information and reports to regulatory authorities and business partners on a global basis without the risk of non-compliance. agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 5

6 According to industry research, the annual cost to own and manage software application can be up to four times the cost of the initial purchase. Streamlining and standardizing IT systems The life sciences industry is inundated with home-grown systems, which has led to inefficiencies throughout the IT infrastructures. In order to maintain regulatory compliance, it is necessary for pharmaceutical companies to streamline and standardize their IT systems. Any major change to existing IT systems can be an extremely costly and time-consuming process, and companies are reluctant to commit their limited resources to update their IT architectural platform because they do not yet realize the importance. Ongoing costs of application ownership With traditional software deployments, the vendor delivers a CD or DVD with the software to the customer. The customer is then responsible for installation, configuration, validation, training, and ongoing support tasks, including account management, upgrades, troubleshooting, and security monitoring. All of these responsibilities are placed on the life sciences company, which must be managed to a tight budget and aggressive project timelines. The software pricing in traditional deployments is usually an upfront fee in exchange for a perpetual user license. All of the tasks associated with deploying and maintaining a software solution are much more costly than the software license costs. According to industry research, the annual cost to own and manage software application can be up to four times the cost of the initial purchase. Studies also indicate that 50-80% of the TCO (Total Cost of Ownership) of an application is attributable to the ongoing people resources that are needed to monitor, maintain and upgrade the safety application and to provide training and support to the end-user base. The SaaS revolution To meet both the challenges of IT and the business, cloud computing with Software-as-a-Service is now becoming a most preferred option for a growing number of companies. As shown in Figure 1, the SaaS model is very different. With a SaaS model, the entire burden delivering the solution is placed on the vendor. The SaaS revolution allows companies to subscribe to software applications and outsource operating the back-end infrastructure to the SaaS vendor. In most cases, the SaaS vendor can do this much more cost effectively, providing overall cost savings for the company. As a result, companies can now spread their pharma IT budget across many more applications to support and grow their business operations, which will, in turn, contribute to the bottom line and future drug development. By eliminating new hardware and software acquisition and maintenance costs, companies realize a substantial savings when moving to a cloud-based SaaS architecture. Page 6 Aris Global Service Overview

7 Traditional Software Deployment Software-as-a-Service Figure 1. Table representing the differences between traditional software deployment and Software-as-a-Service 5% to 20% 2% to 5% Initial Investment Hardware Software Security Network Monitoring/management tools Ancillary upgrades Facilities One-time setup fee 5% to 15% 3% to 5% Deployment Personnel Design Configure and integrate Validation Ancillary updates Launch IT staff training End-user training and awareness Application testing on desktop environment (PQ) Application configuration Launch End-user awareness 5% to 15% 80% to 90% Ongoing Costs Hardware repair and replace Network Security Bandwidth Software maintenance Redundant systems Additional capacity Add-on features Monitoring/management tools Facilities Other (help desk) SaaS subscription fees (this fee is all-inclusive, which includes training, support, maintenance, monitoring, help desk, and future upgrades) 50% to 85% 5% to 10% Ongoing Personnel Scheduled maintenance Unscheduled maintenance Outage response System monitoring End-user service and support End-user training IT staff training Administration, reporting and cost allocations Planning, engineering and testing Deployment of upgrades Security monitoring Marketing awareness and adoption Administration (end-user management) Usage analysis Escalation of user and service issues Help desk agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 7

8 agondemand - THE LEADING SAAS SOLUTION FOR LIFE SCIENCES Aris Global has been dedicated to the life sciences industry for more than 20 years and realized the need of managing business applications and supporting IT operations more effectively. In 2007, we conceptualized and implemented a cloud-based SaaS solution for business-critical and highly regulated applications for our life sciences customers. Our SaaS solution, agondemand, has successfully onboarded a growing number of small, mid-size and very large pharmaceutical, biotechnology, medical device companies and contract research organizations. Aris Global has been in the niche area of application development for life sciences for the past two decades and we have in-depth knowledge of all business, regulatory/compliance and legal requirements and expectations from the health authorities around the globe. We have used our vast knowledge base to ensure that each and every element of our agondemand platform is in line with our customers requirements. Some of the significant key aspects and features of our agondemand platform are highlighted in the following pages. Available for All Aris Global Products agondemand is the ready-to-use, hosted services that enables all companies to use any of Aris Global s software solutions on a subscription basis without the investment in new software, hardware, or even new application and infrastructure support staff. Figure 2. Overview of agondemand managed business services Service Desk Aris Global Solutions for Pharmacovigilance and Safety Regulatory, Clinical Research and Medical Information Applications Service Level Management End-toEnd Support Application, Infrastructure, Training and Business Process agondemand Flexible Deployment Application Support Services per Business Requirements Data Back-up and Disaster Recovery Managed Services Data Security FullValidation Services Highly Secured and Highly Available Environment Business Continuity As shown in Figure 2, agondemand delivers the complete application functionality of Aris Global s product suite to enable life science organizations, regardless of status or size, to reduce their TCO by as much as 35-50%. Page 8 Aris Global Service Overview

9 Comprehensive Data Security and Confidentiality Aris Global understands the importance of client s data security and has built stringent controls to manage customer information assets. Aris Global preserves the confidentiality, integrity and availability of information through a robust agondemand security framework. (For further details, request the Aris Global white paper, agondemand: Addressing the Security Challenges of Software-as-a-Service. ) The agondemand SaaS security framework establishes the security policies and practices necessary to eliminate or minimize the impact that various security-related threats and vulnerabilities might be placed on agondemand and its customers. These policies and practices fulfill all the data security requirements needed to ensure the highest level of data security and integrity for our customers. The security framework is compliant with standards and guidelines such as ISO 27001, HIPAA, European Data Protection Act, 21 CFR Part 11, Annexure 11, Safe Harbor, and SAS 70. The agondemand architecture is based on the Private and Community Cloud approach, which aims to provide each customer with its own dedicated database to ensure confidentiality. Some of the key features of agondemand platform from a data security standpoint: Dedicated data security and security incident management team All data centers are SAS 70 certified ISO certified Remote Management facility Firewall system in place to restrict access from defined IPS and ports Infrastructure divided into Public, Private and Management Zone to protect critical customer data Aris Global preserves the confidentiality, integrity and availability of information through a robust agondemand security framework. Customer environment segregated via VLANs to protect data confidentiality Patch management systems to fix any security holes Antivirus system to block malicious codes Secured encrypted business transactions over 2048-bit SSL certificate Access management system in place to ensure highest level of security Regular penetration and vulnerability tests Applications with strong security framework and pass-through security tests during software development life cycle agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 9

10 Aris Global has achieved 100% success with current agondemand customers being audited by health authorities. Assured Compliance All organizations in the life sciences domain have the obligations to maintain compliance with the terms of regulatory authorities. agondemand ensures that applications hosted on agondemand platform fulfill all these compliance requirements. Some key features of agondemand compliance management include: Robust Quality Management System aligned and certified to ISO 9001:2008 and aligned with all GxP requirements. Monitoring and maintenance process aligned to ITIL guidelines Separate, dedicated and well-trained team of validation experts with vast experience in handling and validating regulated applications. Validation practices aligned to GAMP guidelines A separate compliance team and our own compliance framework to ensure stringent and proper monitoring of all deliverables from the compliance perspective The Life sciences industry demands compliance to a set of regulations specific to particular regions when it comes to managing personal information related to patients or physicians. The agondemand platform takes care of this by different means: Two private clouds/platform: one in the USA and the other in Europe Each platform compliant to cross-border data protection directives such as EU DPD, NHS requirements and Safe Harbor Page 10 Aris Global Service Overview

11 High Availability and Performance agondemand ensures high availability and performance for all the applications hosted on its SaaSbased platform. Redundancy at each layer of agondemand platform ensures high availability and a seamless user experience. Fault tolerant and high-speed storage area network to ensure high availability of data with optimal performance Strong system monitoring and application monitoring in place to quickly identify any possible performance issues VMware virtualized HA clustered platform to take care of any impact on business due to system hardware failure Standby database server readily available to replace primary database should there be any fault in the primary database server Redundant pair of firewalls for load balancing and fault tolerance Clustered deployment of solutions to deliver high availability Proper capacity and availability planning to ensure adequate and accurate resourcing of computing resources Proper back-up infrastructure to restore mission-critical data should there be any need to rebuild systems Applications specifically tested on agondemand platform for performance benchmarking agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 11

12 Fail-Safe Business Continuity The agondemand platform ensures the highest level of business continuity and disaster recovery, which is especially important to data-critical and data-intensive industries such as those found in life sciences. Production site is augmented by an equally resourced disaster recovery site. Standby environments are readily configured to take over should there be any disaster situation at the production site Real-time replication of production data to disaster recovery. RPO (Recovery Point Objective) = Near-zero data loss RTO (Recovery Time Objective) = 24 hours to 72 hours Regular disaster recovery test conducted Figure 3. agondemand s proven architecture delivers real-time data replication As illustrated in Figure 3, Aris Global automatically backs up customer data and stores it at an offsite location. This includes daily incremental and weekly full, onsite backup and offsite transfer of backup data. There is a detailed and documented plan for a hot disaster recovery site and Aris Global conducts regular simulation tests to ensure all operations and data are recovered and available within hours. This provides each customer the comfort of near-zero data loss in case of disaster, using real-time data replication. Page 12 Aris Global Service Overview

13 Multi-Tenancy and Highly Configurable Applications All agondemand hosted applications allocate a distinct schema on the same or different database instances for each tenant. This provides a clear separation of data across tenants and ensures 100% confidentiality. This dedication of a schema per tenant ensures that each distinct schema can be individually integrated with a different enterprise application without compromising the data security of other tenants. The agondemand platform offers a separate, dedicated service for large customers who have pressing reasons to customize their application in order to suit specific business requirements. Scalability to Meet Business Needs agondemand platform runs on a server farm concept and virtualization technology, allowing more capacity to be added on a real-time basis. Applications hosted on agondemand have many background service engine components that help system performance in a more efficient manner than a monolithic system. These service components can be scaled as multiple instances to cater to the needs of an increasing workload. The multiple service instances help balance the load and also work as a fail-over mechanism. agondemand allows adding more instances of these service engine components dynamically to cater to the increasing workloads with zero downtime. The application web layer can also be scaled by adding more nodes to the cluster dynamically, based on the increasing number of concurrent users. Support for Extensive Reporting Requirements Analyzing the collected data and driving meaningful and quick business decisions is the most important part of our customers business needs. The agondemand platform supports extensive reporting support for its customers. agondemand provides seamless integration with SAP Business Objects and IBM Cognos Business Intelligence reporting tools on the agondemand platform. Using either of these technology platforms, customers can generate and fulfill their regular as well as ad hoc reporting needs, whether it is management or regulatory reporting. In addition, Aris Global also offers reporting experts who work with customers to help them design the reports required for their decision making and regulatory reporting. Customization and Enterprise Application Integration The agondemand platform offers a separate, dedicated service for large customers who have pressing reasons to customize their application in order to suit specific business requirements. The agondemand Select platform offers integration to other enterprise applications hosted inside a customer s premise or some other data center through interfaces, application program interfaces (APIs), DB-DB interaction, and other methods. The extent of integration is assessed during the project implementation and can be molded as per customer requirements. agondemand allows integration with customer ERP applications, EDC, Safety applications and other general services such as /fax solutions. agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 13

14 The agondemand team works very closely with customers during the decision-making process and supports them in making a clear, wellinformed decision. Service Level Agreement (SLA) In a life sciences environment, SLAs for business-critical and tightly regulated applications are very demanding. agondemand service management and support platform is aligned to ITIL philosophy, offering globally recognized and well-accepted support practices. 24*7*365 support availability Three ways to contact support: Log ticket on Web portal agservicedesk@agondemand.co.in; Use international toll-free numbers to contact Service Desk representatives, Write an to agservicedesk@agondemand.co.in End-to-end incident tracking through world-class incident management software Adherence to stringent support SLA: Priority 1-8 hours, Priority 2-16 hours, Priority 3-48 hours Engagement manager assigned to each customer for obtaining the right attention of support team Customer Feedback Survey sent with each ticket closer for improving customer expectations Pre-defined escalation path Immediate and Long-Term Benefits agondemand can be deployed as an out-of-the-box solution or configured and integrated with other systems. Unlike other SaaS solutions for life sciences that are developed and maintained by third parties, agondemand upgrades are performed by experienced and certified Aris Global staff. This gives customers the peace of mind that they have a powered-by solution that reflects the innovative technologies of the world s most trusted solution provider for pharmacovigilance and safety. Regardless of the size of an organization, agondemand delivers the following short- and long-term benefits: agondemand s QMS system has been audited and accepted by more than 200 life sciences organizations across the globe. Lowers your total cost of ownership With agondemand, there are no hardware costs or software license fees. With agondemand, customers can start using the platform with a minimal set-up fee and usage-based annual fee. This takes away the customer s challenge of upfront large capital expenditure and unpredictable annual fee. agondemand has helped customers reduce their TCO by almost 35-50%. Page 14 Aris Global Service Overview

15 Simplifies future upgrades agondemand takes care of all upgrades both regulatory and non-regulatory on behalf of our customers. A customer s role is limited to deciding and letting us know if they would like a particular upgrade. agondemand proactively ensures that all new and upcoming regulatory guidelines are implemented well ahead of the timelines to ensure compliance. All tasks involved during upgrade are handled by Aris Global, including database upgrade, data migration, report migration, validation, and documentation. Customers are involved in joint reviews and formal approvals of all steps and related documentation. Eases the migration from in-house to agondemand agondemand understands that a number of considerations come into play when a customer decides to move to a hosted solution: the application usage experience on a SaaS-based platform, size and complexity of current applications, the amount and number of applications, and whether the existing legacy platform is overdue for upgrades, replacements, etc. The agondemand team works very closely with its customers during the decision-making process and supports them in making a clear, well informed decision. Lowers 0ngoing maintenance Aris Global manages and maintains all servers, databases, internal network components, operating systems, databases, and third-party applications along with the installations, upgrades and validation. Controls future IT spending With agondemand, you pay a subscription fee for what you use as long as you use the service. The service fee includes maintenance, support, training and upgrades. Goodbye to perpetual software licenses, maintenance and unpredictable consulting costs. Allows improved growth management agondemand grows with you as your business grows. You can make decisions based solely on initial business needs and easily add services as required. Leverages Aris Global s expertise in life sciences We are a worldwide company with 20+ years of industry experience and a respected partner to many of the world s largest, multi-national pharmaceutical companies. agondemand: SaaS for Business-Critical and Regulated Life Science Applications Page 15

16 ABOUT ARIS GLOBAL Aris Global is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Since 1985, the company has become the chosen partner of many of the world s leading pharmaceutical, biotechnology, and medical device companies. Today, more than 300 life science companies worldwide, including twelve of the top fifteen pharmaceutical companies, rely on Aris Global software to meet international regulatory requirements, manage and mitigate risk, improve operational efficiencies and easily share missioncritical information on a global basis. For information on Aris Global solutions, visit or us at info@arisglobal.com. Page 16 Aris Global Service Overview

17 CORPORATE HEADQUARTERS Aris Global LLC, 2777 Summer Street, Stamford, CT 06905, USA Tel: Fax: UNITED KINGDOM Aris Global UK Ltd, 5-6 Shenley Pavilions, Chalkdell Drive, Shenley Wood, Milton Keynes MK5 6LB Tel: Fax: ITALY Aris Global GmbH, Via degli Ausoni 7/a Palazzo della Cerere Roma Italy Tel: Fax: GERMANY Aris Global GmbH, Inselkammerstrasse 11, D Unterhaching Tel: Fax: INDIA Aris Global Software Pvt. Ltd. SKR Towers, # 19/2, 15th Cross, JP Nagar 4th Phase, Dollars Colony, Bangalore , India Tel: Fax: JAPAN Aris Global KK, TK Shin-Toshin Bldg., 6F1-23-1, Nishi-Shinjuku, Shinjuku-ku Tokyo, Japan Tel: Fax: