SINGLE VIEW OF THE TRUTH? DO YOU NEED A

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1 DO YOU NEED A SINGLE VIEW OF THE TRUTH? Finally: A Web-based solution that seamlessly tracks and manages your global life sciences registration process

2 Expedite drug approvals, slash compliance costs, and streamline submissions and marketing authorizations, health authority queries and commercial opportunities from a single, Web-based application: TRS Tracker. Are You: Experiencing growing cost and time constraints as you move new products through the R&D pipeline, from discovery to market? Finding it challenging to track and manage information as you increase collaboration with affiliates, contract research organizations and licensed partners, globally? Facing increasing complexity in complying with growing regulatory requirements in the U.S., Europe and emerging markets? Would You Like To: Manage compliance and speed product development via a single view of the truth for all registration information across your global value chain? Respond rapidly and accurately to requests for product registration information? Quickly analyze what if scenarios so your regulatory strategists can make informed product growth decisions? Then, help is at hand. In 2013, the U.S. Food and Drug Administration (FDA) approved only 27 new drugs down from 39 the prior year (and well below the 35 projected by McKinsey & Company).* Declining approvals pose a considerable challenge for pharma companies overall. During the past 5 years, big pharma has received approval for only 11 new drugs per year well short of the number needed to sustain the world s multibillion-dollar R&D business.** Increased regulatory compliance is, in part, slowing the approval process. As patents expire, regulations increase globally and R&D costs soar, life sciences companies are under intense pressure to simplify regulatory information management (RIM) to dramatically speed up product approvals. But companies have faced considerable challenges. Despite the promise of new global coding standards and despite significant investments in document management systems many drug makers face a similar obstacle: Regulatory compliance information is still stored in spreadsheets and disparate systems across multiple information silos. Locating this information is time consuming and costly. Your regulatory team may spend days or weeks tracking down files and data to: Respond to a health authority s request for details about a specific product registration Support your product development staffers in maximizing a product s life span by determining in which countries the product is registered and whether or not it is marketed there so they may plan additional registrations Assist your product owners and regulatory managers in determining the impact, by global region, of proposed changes to product registrations Imagine if all of your global registration information were easily and instantly accessible through a convenient electronic search. If all stakeholders had access to a single view of your global registration status and the capacity to produce a variety of standard and ad hoc reports. If you could use a robust Web-based platform to simplify and streamline regulatory compliance and slash costs. * Source: FDA Approvals 2013: DrugInnovation/ucm htm ** Source: FDA Approvals 2012: DrugInnovation/ucm htm Now, you can accomplish all these actions with TRS Tracker. 1

3 WHAT IS TRS TRACKER? TRS Tracker provides a central, Web-based repository for global product registration information and a decentralized solution for simplifying entry of new registration information. Through TRS Tracker, you can quickly, thoroughly and globally manage and track the change status of every product in your company s life science portfolio. This intelligent database streamlines and simplifies: Worldwide product registrations and marketing status Marketed product variations/changes through health authority approval and implementation, such as a manufacturing site s name change Regulatory authority correspondence and post-market commitments and requirements, e.g., pediatric studies, Phase IV studies and more Routine maintenance submissions, e.g., annual compliance reports, periodic safety updates and renewals HOW DOES TRS TRACKER WORK? TRS Tracker enhances portfolio management by showing which products have been submitted where, which products are approved to market, and which face expiring registrations or sunset clauses. It then issues automated notifications for specific task completion by the appropriate stakeholders. Submission details are captured at a granular level, for more efficient tracking of submissions and applications, including: Application type Procedure type Submission type (regulatory activity/event) Sequences Submission format Responsible regulatory manager/affiliate Related health authority correspondence and queries Operational Value Information Integration Improve information flow Simplify processes Eliminate rogue systems Improve operational efficiency Health Authority Q&A Compliance Status Commitment Management Submission- Relevant Content Labeling and Safety/PV Cohesive Regulatory Information Management Capability Building Blocks Registration Management Submission Management Correspondence Management Regulatory Intelligence Strategic Value Information Aggregation Timely decision-making Better portfolio management Compliance at a reduced cost Improved information confidence and reliability Easier consumption (dashboards) Figure 1: By providing a single view, a centralized regulatory information management (RIM) solution speeds decisions while slashing compliance costs (Source: Gens and Associates, white paper, Fall 2012). 2

4 TRS Tracker v5.3 Benefits A robust and feature-rich application, TRS Tracker v5.3 offers tremendous value. It delivers a superior regulatory information management solution that includes: A holistic view of vital product information on registrations and authorizations Time-saving automation of routine processes Enhanced collaboration through data centralization More-efficient access to product licenses and marketing statuses worldwide via improved facilitation of decision making, analytics and reporting Integration with the rest of CSC s Total Regulatory Solution (TRS) family With TRS Tracker, you can monitor activities to ensure that your plans are on schedule and keep detailed records of all completed, current and planned activities. With a completely redesigned technical architecture and user interface, TRS Tracker simplifies regulatory information tracking and management in five key areas: Product Management. With crucial regulatory information at your fingertips, you can organize and plan resources for peaks in the submission pipeline, thereby minimizing the risk of late submissions and maintaining control over critical data. Users can monitor market approvals against target dates to ensure that marketing launches are on schedule. Registration Tracking. A one-stop, authoritative location for registration data offers a clear improvement over the multiple, disparate spreadsheets and formats that your competitors still use. TRS Tracker also provides an instant view of all your products current registration status. Submission Management. A centralized view makes it easier for users to maintain, track and manage submissions and approvals. Correspondence Management. All correspondence between sponsors and health authorities is tracked and easily retrieved. Commitment Management. Routine commitments or requirements, such as annual reports and safety update reports, as well as post-marketing commitments, are tracked and managed to completion. TRS Tracker s automatic notifications remind users of approaching milestones. FAST AND EASY WEB ACCESS TRS Tracker puts regulatory information at your fingertips via the power of the Web. The direct data access user interface offers a powerful search engine, an interactive world map for streamlined viewing of information about individual regulatory regions, and a unified view of information that promotes global stakeholder collaboration. REPORTING OF RELEVANT INFORMATION By managing all of this information in one repository, users can generate reports that contain the information important to them. TRS Tracker quickly locates the needed information and can save it to PDF, Microsoft Excel or Word and CSV formats. In addition, TRS Tracker leverages a third-party tool to provide robust reporting functionality while minimizing development efforts. Standard reports can be automatically generated and distributed on a pre-defined routine basis. 3

5 WHAT IF ANALYSES A key benefit of TRS Tracker is its change-log capability, which provides the following key features: Perform impact analyses identifying applications impacted by a change, e.g., label change, manufacturing site change, etc. Automate creation of related submissions and tasks Automatically notify responsible personnel of impending submissions Track and manage the status globally via one holistic view Source Record Associated Applications (13) Submissions Containing Change (13) Related Tasks (13) We designed TRS Tracker s data model to simplify compliance with the European Union EudraVigilance Medicinal Product Dictionary (EVMPD) and allow for expansion, to include emerging regulations and standards. In addition, Tracker 5.3 includes an add-on XEVMPD module for end-to-end processing that identifies and submits updates, and obtains Acknowledgement and Message Disposition Notification messages directly from the European Medicines Agency. To build commonality into the model, Tracker incorporates our experience and best practices from both CSC FirstDoc, our life sciences document management and collaboration solution, and CSC ectdxpress, which simplifies Electronic Common Technical Document (ectd) submissions. SIMPLIFIED BUSINESS PROCESSES As a leading technology innovator and systems integrator with regulatory domain expertise, we give you deep visibility into your regulatory information and streamline and simplify your underlying business processes to address your integration challenges. As your one-stop technology and regulatory services vendor, we are positioned to be your single point of contact for all your regulatory needs. ROBUST SECURITY TRS Tracker s security model will readily increase information access to stakeholders across the globe as it secures your sensitive data. Tracker can configure user permissions to ensure that users have access to the information they require, while not oversharing product information. Groups can be established to govern access to records based on product, market, role and so on. This ensures that users see only the information that is relevant to them. NEEDED: SINGLE SOURCE OF THE TRUTH Today s forward-thinking biopharmaceutical companies are transforming their RIM approach to improve decisionmaking. For many, TRS Tracker is the go-to solution to produce more reliable and actionable intelligence throughout the product development lifecycle. It enables them to: Better manage submissions and marketing authorizations Respond more rapidly to health authorities queries Reduce non-compliance financial penalties The following features of TRS Tracker will enable your organization to more effectively manage compliance and regulatory commitments: Change-log functionality Correspondence- and commitment-management capabilities Built-in business rules that automatically plan routine maintenance submissions TRS Tracker s single, Web-based repository for product information will centralize your regulatory planning. As your network of external service providers, global affiliates and new market entries grows, Tracker will streamline and simplify portfolio management giving you the confidence to make informed decisions as regulatory scrutiny increases. Built upon proven CSC best practices and domain expertise, and implemented by our highly experienced integration teams, TRS Tracker will help you: Incorporate existing business processes into a single Web-based database Replace old and inefficient spreadsheet business processes Further reduce operating costs by replacing multiple point solutions with one core application that provides a single source of truth for your organization s most critical asset: regulatory product information Data Prepare Manage Result External Applications Internal Teams External Teams Registration Details Plan Manage Track Report Registration Clinical Trial Authorizations Marketing Authorizations 4

6 WHY CSC? In today s regulatory environment, companies must wade through numerous complex steps in the regulatory submission and approval process. CSC s professional services help you expertly manage these challenges, from data analysis and documentation preparation through final submission compilation. Our services portfolio spans data management, regulatory affairs and regulatory writing. CSC s time-tested methodologies ensure project success regardless of format (ectd, paper, or non-ectd electronic submissions [NeeS]) or approach (first-time submission, conversion of paper to ectd, or reuse of a regulatory submission from one market to another). Drawing upon extensive global resources, our expert team provides domain expertise in multiple therapeutic categories, such as autoimmune, cardiovascular and infectious diseases; oncology and neurology; and drugs, devices, gene therapy and genetics. To date, CSC has compiled thousands of regulatory submissions in more than 70 countries, including more than 6,000 ectds. Because of our commitment to accuracy, we have never had a refusal to file based on errors in submission compilation. In addition, our long-standing relationships with CDISC and Health Level Seven International (HL7) give you access to industry best standards. 5

7 CSC S TOTAL REGULATORY SOLUTION FAMILY TRS Tracker is the cornerstone component of CSC s groundbreaking Total Regulatory Solution (TRS), an integrated application suite providing support for end-toend regulatory information management. TRS drives interoperability between content management, publishing and registration tracking, providing cradle-tograve monitoring of regulatory content and data. Tight integration between the suite s products results in highquality and intelligent documents, dossiers and registration records that increase R&D productivity. CSC is the only technology and regulatory services vendor to offer a full suite of applications and domain experience that specifically target the needs for global product registration, including: Content management Regulatory information management Both ectd and paper submission, e.g., NeeS and ASEAN Common Technical Dossier (ACTD) dossier publishing applications Productivity applications Robust business process outsourcing services Regulatory consulting services available in a cloud environment or as-a-service At a Glance: CSC s Total Regulatory Solution Innovate and Improve the Process An application family providing integrated support for the end-to-end regulatory information management process, including: Planning submission, tracking components through entire lifecycle Full integration with content management and publishing Provide Regulatory Affairs with decision impact analysis and advanced planning tools Global view of submission regardless of origin and archival platform Author & Approve FirstDoc CRX/Writer Plan, Track and Manage TRS Tracker Publish PDF Publish ectdxpress Publisher VLM and ToolBox Access, View and Navigation TRS Viewer Archive TRS Exchange For more information about TRS Tracker, visit CSC Life Sciences at csc.com/tracker 6

8 Worldwide CSC Headquarters The Americas 3170 Fairview Park Drive Falls Church, Virginia United States Asia, Middle East, Africa Level 9, UE BizHub East 6 Changi Business Park Avenue 1 Singapore Republic of Singapore Australia 26 Talavera Road Macquarie Park, NSW 2113 Australia +61(2) Central and Eastern Europe Abraham-Lincoln-Park Wiesbaden Germany Nordic and Baltic Region Retortvej 8 DK-2500 Valby Denmark South and West Europe Immeuble Balzac 10 place des Vosges Paris la Défense Cedex France UK and Ireland Region Royal Pavilion Wellesley Road Aldershot, Hampshire GU11 1PZ United Kingdom +44(0) About CSC CSC is a global leader in next-generation IT services and solutions. The company s mission is to enable superior returns on our clients technology investments through best-in-class industry solutions, domain expertise and global scale. For more information, visit us at Designed and produced by CSC s Creative Services Computer Sciences Corporation. All rights reserved