Clinical TOTAL CLINICAL THE COMPLETE CLINICAL CLOUD. Clinical on the Cloud. Total. Clinical Data Management. Operations. Clinical

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1 Powe r i n g C l i n i c a l D eve l o p m e n t f r o m C o n c e p t t o C o m m e r c i a l S u c c e s s Data on

2 CLINICAL RESEARCH SUCCESS Company efforts to speed development, boost success rates, and control runaway R&D costs, all of which are critical to improving R&D efficiency, require objective, robust metrics. Tufts CSDD Outlook 2014 Data on

3 Powering Trials from Start to Finish Do you face: Increased pressure to mitigate risks? Rising clinical development costs? A constantly changing regulatory environment? Intense competition and the race for faster time to market? An incomplete view of clinical activity and progress? development challenges have never been tougher, forcing sponsors to be smarter and more creative in how they conduct and manage clinical research. To succeed, life science organizations must: Integrate and converge clinical development systems intelligently. It s now possible to integrate clinical systems without the complexity and pain of point-to-point efforts that fail to deliver consolidated information and data for improved decision making and better metrics. Ensure compliance without exception. Frequent changes in R&D regulatory requirements involve systems that provide the robust capabilities to ensure compliance across the globe with complete confidence. Deliver a holistic overview of clinical activity, metrics and data. Improve oversight and reduce costs and timelines by giving your clinical development teams the ability to access complete, integrated views of site / study / program status from their desktops or mobile devices. Work smarter. Organizational reductions in staff and budgets may be your present or future reality making it all the more reason to optimize and automate business processes that streamline activities and foster collaboration and knowledge sharing for greater operational efficiency. Power your R&D with ArisGlobal ArisGlobal helps sponsors and CROs power their clinical trials from beginning to end with an advanced e platform that, for the first time, fully integrates your clinical systems whether from ArisGlobal, third-party suppliers, or your own internally developed solutions.

4 - The Complete Cloud Data on

5 for Optimized The platform streamlines clinical operations, drives down costs and optimizes trial outcomes: CTMS: ag delivers comprehensive functionality to plan, track and control all clinical trial tasks. For complete automation and to reduce redundant data entry, ag can be integrated with other corporate department systems including finance (e.g., SAP ), safety, trial disclosure and EDC systems. Investigator Site Portal: agcenter facilitates the communication and collaboration between sponsors and clinical study sites. Trial Disclosure: agdisclosure efficiently manages trial registration and reporting of results to global registries. Safety-to-Investigator Reporting: agnotify automates the electronic distribution of safety reports to investigators and others; integrates out of the box with ARISg, ArisGlobal s adverse event reporting system and, through web services, can integrate with CTMS databases, including ag. for Unified Data Many elements of EDC, epro and RTSM databases are common across the three applications. offers a unified CDM platform that significantly reduces study build times: EDC: agcapture captures, cleans and reports clinical trial data; fully integrates with CTMS to manage clinical trials seamlessly from end to end. epro: agoutcomes facilitates data management activities such as capturing data directly from the patient, notifying them when intervention is required and providing status updates when posted. Medical Coding: agencoder automates and standardizes the medical coding process. RTSM / IWRS: agsupply automates the tracking of clinical trial supplies throughout study sites, warehouses and supply depots.

6 Integrate Systems Intelligently The R&D environment of most life science companies consists of numerous clinical development systems from multiple vendors. These systems tend to have different technology standards, which require more time to manage diverse infrastructure and support requirements. How can you mitigate the ensuing complexity fatigue? Integrate All Systems Regardless of Vendor empowers customers with a complete suite of solutions that provides comprehensive functionality. is also completely flexible so that your organization can easily swap in and out third-party or in-house solutions with full interoperability and without the complexity fatigue of point-to-point integration. Simplify Vendor Complexity and User Acceptance By reducing the number of vendors to manage and simplifying infrastructure and support requirements, helps customers drive down cost. All clinical programs are accessed through one browser window, providing a convenient and easily accessible way to find, retrieve and combine data from different clinical systems. Reduce Data Redundancy Our smart integration approach enables companies to enter data once, so they can control and share it seamlessly across the enterprise. This results in greater data consistency and reduces both data redundancy and the potential for human input error. Smart integration turns IT from a cost center to an asset that delivers efficiencies, better decision making and improved trial outcomes. Integrate Beyond can also be integrated with ArisGlobal s solutions for pharmacovigilance and safety (ARISg /ARISj ), regulatory affairs (Register ) and medical affairs (aginquirer ). Data on

7 Deliver a Holistic Overview of Activity For most organizations, their vast volume of clinical data resides in disparate silos. The ability to access and view realtime, consistent, quality data is difficult and nearly impossible to achieve. This inability threatens both study timelines and compliance. It also continues to put the goal of making the data collection and management process more efficient and predictable out of reach. Leverage Today s Modern Technology and Standards is a scalable e platform that enables sponsors and CROs to address common operational and management challenges in clinical development. Our use of modern technology and evolving standards, including CDISC ODM ( Data Interchange Standards Consortium Operational Data Model), gives users centralized access to a suite of scalable, interoperable applications and critical performance indicators, metrics and reports all from a fully enabled portal. users only need one user name and password to access all e solutions, including third-party vendor applications and homegrown systems. Applications and the agworld portal are fully integrated via web services/soa using CDISC ODM standards. Connect Users to the Information They Need s agworld portal delivers information via a single, integrated dashboard. Users are shown key performance indicators and given collaboration tools, such as online chat. These dashboards are role-based and can be created and customized for each user at different levels of the program to provide instant access to trial data. Instant access to information and drill-down capabilities give users a holistic view of their trials and enable improved communication between peers. Reduce Study Build Times offers a solution where EDC, epro, randomization and supply management are all built on one platform. CDM teams can shave many weeks off study build times, achieve instant and full data consolidation with zero effort, and eliminate duplicate site and user administration and training.

8 Ensure Compliance without Exception Regulatory agencies continue to increase the scope and breadth of compliance efforts required to manage and mitigate the risks of clinical R&D. At every stage of a clinical trial, the activities requiring compliance demand the best. In the face of possible trial setbacks or heavy fines, compliance is paramount. How can organizations ensure compliance? Take Advantage of Advanced Trial Registration and Results Disclosure agdisclosure enables life sciences organizations to efficiently manage clinical trial registration and reporting of results, ensuring compliance and consistency of data published in registries worldwide. Provide Intelligent Oversight ag helps plan and track every aspect of clinical trials, enabling complete oversight. Extensive features allow sponsors and CROs to monitor their progress in multiple trials, which are becoming increasingly complex. Automate and Streamline Reporting Processes Using agnotify, companies can automatically and securely distribute clinical safety reports, including SUSARs and aggregate line listings, to investigators, IRBs/IECs or any other stakeholders in support of differing regulatory obligations. Manage the TMF with Complete Confidence Since the CTMS is the daily workhorse of any clinical operation team, having the electronic trial master file (etmf) closely integrated or a part of the CTMS is essential. ag gives study teams complete TMF functionality for efficient, secure document archiving and storing. ag also provides full document management and etmf functionality for the timely, efficient and secure exchange of trial documentation and management of the investigator file. Data on

9 Work Smarter Delays in accessing timely trial information. Decisions made based on incomplete knowledge. Redundant efforts that waste staff resources and money. Investigators frustrated by a lack of transparency and communication with sponsors. Challenges like these need solutions that provide a better, smarter way of working one based on collaboration and knowledge sharing. Foster Collaboration The agworld portal fosters collaboration and changes the way sponsors conduct their clinical research programs. Users have centralized access to all critical clinical trial data and documentation for a single trial or across multiple trials. agworld supports online collaboration tools such as online chat to facilitate communication and collaboration between all agworld users. Improve Site Relationships agcenter is the investigator site portal that enables sponsors to facilitate and streamline communications and collaboration with study sites, helping reduce the time and cost of administrative management. From an intuitive dashboard, study site staff are provided with role-based access to information including TMF-related documents, training modules and records, feasibility questionnaires and safety reports. Leverage for Lower TCO Today, more than 100 companies from Top 10 pharmas to small biotechs to CROs of all sizes have chosen to deploy an ArisGlobal solution on the agondemand cloud, eliminating the cost and pressure of maintaining sophisticated IT infrastructures. Each hosted solution is backed by a global service delivery model that caters to the day-to-day needs of business users, thereby allowing customers to focus on their core business activities and lower their total cost of ownership. agondemand leverages the SaaS (Software as a Service) delivery platform to offer all ArisGlobal products on its private cloud, dedicated and aligned to the specific needs of the life sciences industry.

10 In the realization that the status quo has no chance of delivering longterm industry sustainability, the ability to work and collaborate effectively on an ever-expanding global and value chain basis is a key and core capability that companies will need to succeed, both now and over the foreseeable future. IDC Health Insights Best Practices: Collaboration as a Key Success Factor in Life Science Industry Transformation (Document #H ) Data on

11 About ArisGlobal For over 25 years ArisGlobal has been a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality and compliance for medical inquiries. Solutions are available on premise or on a regulated cloud platform. Life science companies using ArisGlobal s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world. The mission of ArisGlobal is to provide the life science industry with the most complete information management environment to bring the highest levels of trust of one's company and products to their customers (patients, practitioners and government administrators).

12 Corporate Headquarters ArisGlobal LLC 1266 East Main Street Stamford, Connecticut T: F: International Offices Europe: Belgium, Germany, Ireland, United Kingdom Asia Pacific: India, Japan Location details: arisglobal.com/about-us/worldwide-locations Data on Copyright ArisGlobal LLC. All rights reserved. All trademarks are the property of their respective owners. BRO-TC-1114