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DOUBLEBRIDGE TECHNOLOGIES www.doublebridge.com Bridging Technologies and Your Business Global IT Solutions Provider for Global Pharmaceutical Companies

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Page 1: Bridging Technologies and Your Businessdoublebridge.com/pharma.pdf · ner in your success. We work closely with you to improve processes, reduce operating complexity, and provide

DOUBLEBRIDGE TECHNOLOGIES www.doublebridge.com

Bridging Technologies and Your Business

Global IT Solutions Provider for Global Pharmaceutical Companies

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Table of Contents

2 Who

2 What

2 How 3 Quality3 Speed3 Methodology3 Value

4 Major Service Lines4 Custom Software Development & Maintenance4 Database Services4 Information Architecture & UI Design4 Quality Assurance & Test4 ERP Systems

5 How We Are Structured

6-7 Our Commitment to Life Sciences/Pharmaceutical Field Force

8-18 Case Study

DOUBLEBRIDGE TECHNOLOGIES

www.doublebr idge.com

Bridging Technologies and Your Business

BeijingParisJapan

Hong Kong

DoubleBridge OfficesDoubleBridge Projects Locations

BostonNew

TexasMexico

California

Minneapolis

DenverXiʼan

Headquarters - New JerseyDoubleBridge Technologies, Inc.103 Carnegie Center, Suite 317Princeton, NJ 08540Phone: +1-609-716-9001Fax: +1-609-716-9002

Boston Office20 Mall Road, Suite 151Burlington, MA 01803Phone: +1-781-221-6909

Fax: +1-781-221-6959

China Office - BeijingA2105, Eagle Run PlazaNo.26 Xiaoyun RoadBeijing, ChinaPost Code: 100016 Phone: +86-10-8458-4219Fax: +86-10-8458-4219 ext 110

General InquiriesFor general inquiries, please send an e-mail to: [email protected] [email protected]

Contact Information

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Who We Are

DoubleBridge Technologies, Inc. is a leading provider of technology and innovative software services. Head-quartered in Princeton, New Jersey, USA, with worldwide offices in Boston, Toronto, Paris, Hong Kong and a development center in Beijing, China, DoubleBridge has excellent technology talent in the USA, China and beyond. DoubleBridge develops and supports mission critical enterprise-class products, solutions and sys-tems for Fortune 500 enterprises and World-Class organizations. Utilizing the robust global (network) infrastructure, DoubleBridge possesses the ability and flexibility to deploy the services onshore, offshore, near-shore and offshore-onshore to our clients located in North America, Japan, and Eu-rope. DoubleBridge client list spans multiple markets with industry leaders from the Fortune 500 such as Petroleos Mexicanos, Pfizer, Aventis SA, Microsoft, and Hewlett-Packard. The client list also includes World-Class orga-nizations such as The World Bank, The United Nations and Massachusetts Institute of Technology.

What We Do

With a seasoned, highly experienced management team, strong technical and resource management system, deep industry knowledge, and established relationships with leading organizations, Doublebridge is ready to bridge the gap between business and technology with finely tuned services and solutions.

DoubleBridge has substantial experience developing software/application solutions and services for a wide range of industry sectors. We provide consulting and integration services to life sciences/pharmaceutical, financial services, health care, software development, and telecommunications companies.

How We Do It

At DoubleBridge, we believe in contributing more than just technical resources. We view ourselves as a part-ner in your success. We work closely with you to improve processes, reduce operating complexity, and provide the perfect fit for your immediate needs. Most importantly, we keep our focus on your future needs, by designing and implementing scalable systems.

Established in 1997 by a group of former Oracle, IBM and Microsoft employees.

Worldwide offices in: Boston, New Jersey, and Beijing, China

Over 150 Software Developers

Leading venture capital firms as investors: IDG, iVenture, and Global Strategic Investment, Inc.

Well-known Private Investor: Dr. Michael Dertouzos - Former Director MIT Laboratory for Computer Science

Company Facts

Industry Highlights

Life Sciences/Pharmaceutical

Financial Services

Telecommunications

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QualitySpeed

Methodology Value

DoubleBridge

Information Architecture & UI Design

Custom Software Development and Maintenance

Database Services

ERP System Implementation and Maintenance

e-Business & Internet Applications Development and Maintenance

Software Localization and Globalization

Quality Assurance & Testing

Legacy System Maintenance and Migration

Major Service LineDoubleBridge is a customer-oriented company. We start working for you by looking at your demands, your expectations, your time frame, and your budget. It is our mission to deliver the most cost-effective and powerful solution for your needs, quickly. and with high quality.

Quality

Our highly skilled teams thrive on meeting the diverse and sophisticated demands of our clients. We bring an ongoing focus to mastering evolving technologies so that our clients receive the best solutions available. We have the breadth of experience and the knowledge base to meet any implementation challenge and deliver the most comprehensive solutions with speed and reliability.

Speed

We deliver projects on time without exception. Our proven distributed development methodol-ogy allows us to provide rapid solutions by utilizing our vast global resources. Our development teams work in unison in the U.S. and Asia, allowing the round-clock real-time development. The com-bination of our powerful resources and proven expertise results in a fast and high-quality project delivery.

Methodology

We are committed to bringing unprecedented client value to each engagement. We develop technology to fit your needs. Our project team Partners with our client to find a flexible, affordable solution that will deliver the most for their business. We build systems that are dy-namic in nature so that as our client’s business evolves, their technology is right in step.

Value

We believe in provid-ing the best software services at the most competitive rates. We organize our operations to be as streamlined and effective as possible and deliver pricing to our clients that reflects our efficiency. We have structured ourselves to give our clients an immediate competitive advantage through solu-tions that are innovative, flexible, and most of all, cost-effective.

Clients choose DoubleBridge for our high-quality practices in the field. DoubleBridge has developed a unique software execution model focused on product development, global collaboration, and delivery excel-lence through process maturity. Product development imperatives are deeply embedded in our development framework (D-Framework) and institutionalized as best practices.

Partners

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Major Service Lines

We realize that its not only what we do that is important, but also how we do it. That is why DoubleBridge has invested in the tools and infrastructure that will allow us to work the way our client would like. Our work has centered around these service lines:

Custom Software Development & Maintenance

DoubleBridge helps clients put their application to work. We solve a diverse set of business problems in every aspect of our clients’ business in various industries. Our team is dedicated to using the right technology for the job and has the skills and experience to work confidently and efficiently.

Database Services

DoubleBridge provide a full range of related services and solutions for most industry standard database products including Oracle, SQL Server, DB2 and Sybase. Our extensive experience with many different products and industries can provide our clients with the assistance they need for their database problems.

Information Architecture & UI Design

Good design distills and seamlessly integrates business challenges, user needs and complex technologies.DoubleBridge Information Architecture and Graphic Design services ensure that the systems we develop not only look good, but work well and add to the bottom line by making people more effective and efficient through superior user interfaces.

Quality Assurance & Testing

Quality solutions begins with a committment to quality. Quality can be found in our internal reviews, rigorous levels of testing and structured quality checks. It can also be found in our individual team members who bring a passion and unparalleled attention to detail to everything they do; and in the end product we deliver.

ERP Systems

DoubleBridge provides ERP systems support and services to enhance our clients abilities to compete in a technology-driven world. ERP systems are now the engine of virtually every enterprise. DoubleBridge can speed up your business engines by automating most aspects of performance tuning, upgrading, patching, and manag-ing of Oracle, SAP and Baan ERP applications.

Software Development Tools: Java, C, C++, Visual Basic, Perl, .NET

Application Development Tools: JavaScript, XML, SOAP, HTML, DHTML, ASP, JSP, Tcl, VB Script, OMD, Jdeveloper, BC4J

Software Modeling: Rational Rose, UML, OOSE, OMT, Oracle Designer, ERWin

Relational Databases: Oracle, SQL Server, Sybase, DB2, UDB

Application/Web Servers: BEA Weblogic, Microsoft IIS, Netscape, AOL Server, Apache

Application Servers: BEA Weblogic, ATG Dynamo, Cold-Fusion, IIS Middleware: CORBA, COM+, RMI, MOM, Entera

Applications: PlumTree, Documentum, Oracle Application, Oracle Manufacture, BAAN, People Soft, Abase, CoreDossier,

Knowledge Base

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How We Are Structured

Our passion is delivering solutions that empower organizations to compete in the ever-changing economy. Each employee from our company brings experience, wisdom, knowledge and a true passion for creating innovative solutions that change the way you work and that empower you to beat your competition. When working with our professional consultants, you will experience how our integrity, accessibility and the ability to communicate clearly

and openly contribute to the overall success of implementing the solutions to your problems.

The Value of a Dedicated Team

Our dedicated team is on call to address every one of your needs and concerns as they come up. We guarantee that somebody will be there to help you at anytime.

The Value of Local Knowledge

While most companies try to manage utilization by staffing their consultants on multiple proj-ects with multiple clients, we believe that success of ours and yours only comes through qual-ity work and quality relationships. One of the most frustrating aspects of working with vendors is the need to familiarize them with your environment. By focusing our organizational structure around a handful of clients.

We are able to quickly acquire a thorough familiarity with your organization, business chal-lenges, technical environments and political climate. This minimizes this level of ramp up time and enables our project teams to hit the ground running.

The Value of an Offshore Development Center

Our offshore developing center will help you on your projects, with remarkably fast turn around time and proven quality standards, and especially the reduced costs. Our local (U.S.) senior technical management teams constantly oversee the projects to adhere to our clients require-ments. We can cut your costs and increase efficiency with strategic planning, rapid develop-ment, testing and deployment.

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DOUBLEBRIDGE TECHNOLOGIES Life Sciences/Pharmaceutical

DoubleBridge Technologies positions itself as a global information technology solutions provider for pharmaceutical compa-nies. We provide technology solutions for life sciences and pharma-ceutical industries to utilize information effectively and transform key business practices. Our technical activities cover the whole pharma-ceutical development life cycle - from discovery, to clinical trial and regulatory submissions. DoubleBridge delivers solutions that help our clients prioritize, plan, and implement the right technology solutions to meet their needs.

Our solutions, knowledge and expertise cover the spectrum of innova-tive projects in the life science industry including:

Bridging Technologies and Your Business

Bioinformatics and Genomics

Clinical Trials

Lab Information Management

21 CFR Part11

System Validation

NDA Submission

Data Integration & Aggregation ToolsRelevant

Knowledge

Others

DoubleBridge Solutions

Bioinformactic data management system Laboratory experience data management system Laboratory logistical information tracking & management sys-tems Drug discovery data integration & data warehouse systems Clinical trials data management systems Validation system FDA 21CFR Part 11 Compliance Web based auditing tracking system Regulatory affair document retrieval and archive system NDA e-Submission system Patient monitoring system Pharmaceutical sales information management system

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DevelopmentDiscovery

Regulatory Affairs & NDA Submission

Sales & Marketing

DoubleBridge Solution Diagram

DoubleBridge provides solutions for the entire value chain. For the Drug discovery area, our solutions acceler-ate the discovery life cycle. For drug development area, our solution helps our clients to streamline clinical data capture, reporting, validation and integration.

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3Ds, BioInformatic Suite, SDMS, Abase Support, 2D Gel Tracking, Clone Database, Data Sync. Integration. Remote Application Support

Oracle ClinicClinicSoftClinic TrialClinic SaveData Warehouse

e-Submission21 CFR Part 11ServicesWATSRADARSNDA SubmissionAPML

Regulatory AgenciesBiomedical/Pharmaceu-tical Companies

DistributorsBiotech/Pharmaceutical Research Labs

Do

ub

leB

rid

ge

So

lutio

ns

Business Activity Monitoring ToolSales Distribution Data WarehousePatient Information Management System

Our Clients

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DOUBLEBRIDGE TECHNOLOGIES Case Study 1 - Cloning Information Repository system

Problem: No system existed for scientists to find out whether a clone in which they were interested was available in the company.

Impact: The lack of easy access to clone information became the bottleneck of the business process and created duplication of work.

Problem: Scientists relied on Sequencing, Cloning and Finishing Group (or Clone Management Group, in short) to find out the answer for them.

Impact: The long turnaround time for clone requests prevented the scientists from reaching their full productivity and efficiency, and hindered scientific research. Ultimately, it increased the time for the company to bring innovative drugs to the market.

Problem: Clone Management Group had access to some of the information, the needed information, however, was stored in different locations (U.S. and Germany) in different formats, such as Microsoft Word, Excel, Access and plain text files.

Impact: The Clone Management Group was burdened by manual management and retrieval of clone data.

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Client Background

A major pharmaceutical compa-ny that has operations in United States, France, Germany, Japan and other countries.

Drug discovery and develop-ment plays a major part in company operation.

Business Problems

End Users

Location 1

Location 2

Location 3

Request & Reply

Clone Management Group

Before Implementation

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The Challenges

There were concurrent developments of other initia-tives within the client company while those initiatives were in the early stage of scope definition and did not have concrete time lines. It was a requirement that the system should be delivered on time and be integrated with systems produced by those initia-tives.

The Approach

DoubleBridge took an iterative approach in which four rounds of preview versions were released to progressively elaborate the requirements. We used Object-Oriented design and analysis to ensure a flexible design that could be easily adapted to the changes and uncertainties of other initiatives.

Solution: DoubleBridge implemented a centralized repository of clone data and a browser- based application to allow global access to the repository.

Benefit: Improved productivity. Scientists can now find clone data without relying on the Clone Management Group. Clone Management Group can now focus on the sequencing, cloning and finishing activities instead of spending time looking for clone data in many different places. Elimination of duplication of work. A globally accessible system allows easy sharing of clone information among geographically distributed sites and greatly reduces the possibility of duplication of work.

Solution: The new system is integrated with the Cloning Laboratory Information Management System (LIMS). The integration allows clone data produced in LIMS to be automatically registered in the repository in a controlled environment.

Benefit: The integration allows clone data produced in LIMS to be automatically registered in the repository in a controlled environment. Better utilization of valuable information.

Solution: The Clone Request and Fulfillment subsystem is integrated with the existing clone inventory system to provide end-to-end tracking of the ordering and fulfillment process. As part of the solution, the publishing services of the system periodically exports bioinformatics data in formats that were acceptable to other BLAST servers.

Benefit: The browser-based system allows easy access to the information. The publishing services of the system makes the valuable information available to other applications and reaches a broader user base within the company.

DoubleBridge Solution

DoubleBridge built a scalable systems environment on an enter-prise grade Database Management System that satisfied the needs of the growing user base and user activities.

DoubleBridge delivered the solution on time in 8 months. Our flexible design and iterative approach allowed the project team and the solution to cope with changes.

Project Highlights

End Users

Clone Management Group

Clone DB

System

Interaction

After Implementation

Case Study 1 - Cloning Information Repository system

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Problem: Lack of integration among the company’s compound registration systems, logistics system and laboratory information management systems

Impact: Operational inefficiencies and data inconsistencies.

Client Background

A major pharmaceutical compa-ny that has operations in United States, France, Germany, Japan and other countries.

Drug discovery and develop-ment plays a major part in company operation.

Business Problems

Case Study 2 - Lab Data Syndication System

Disparate applications and distributed data stores - five different applications span across four sites glob-ally (U.S., Germany, and France). More than 20 databases were involved.

The Challenges

Solution: DoubleBridge implemented a solution comprised of automated, subscription-based data distributors and message queues where applications can publish data to subscribers through a chain of distributors. Instead of point-to-point communications, applications send messages to a distributor and receive messages from a distributor. A distributor maintains subscription information and dispatches sync jobs to asynchronous transactional queues. A distributor is placed at each site for load balancing and fault tolerance. Acting as routers, distributors communicate among themselves to form a global network of data/message exchange. In addition to the automated back end processing, DoubleBridge also implemented a web-based user interface for external compound registration, sync conflict resolution, error handling and re-publishing.

Benefits: Increased operational efficiency. Elimination of on-demand manual data transformation and loading which was the bottleneck of the process. Consistency of selective data sets across systems. A robust store-and-forward distribution mechanism that accommodates system or network downtime and guarantees the delivery of messages when the systems and network come back online.

DoubleBridge Solution

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DATASYNC

APP ALICE

DATASYNC DATASYNC

ESMACTIVITY BASE

ACTIVITY BASE ACTIVITY BASE

APP APP ALICEALICE

ESM ESM

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The Challenges

Software for Japanese use must be fully localized to meet the language,cultural, and technical needs of users. To maintain its leadership position,Phase Forward must support its customers regulatory compliance activitiesa cross the globe.

DoubleBridge Solution

DoubleBridge helps to ready Clintrace, the client’s adverse drug event reporting solution, for use in Japan. This project is more than a simple language translation, it is a localization pro-cess. It is a process of • adapting the software for Japanese Kanji characters • adding reports to meet specific Japanese managerial needs and governmental regulations • maintaining flexibility for multiple client platforms • delivering a commercial software product ready for upgrading to new versions and releases

DoubleBridge’s experience in globally distributed development, Japanesesoftware, and the pharmaceutical industry provided a strong foundation forcollaboration with the client’s software development teams in Boston andJapan. Continual communications in person, by telephone, and by internetleveraged the U.S.-China time difference to deliver rapid responses to issuesthat arise in the development process .

Technical Specifications

• Kanji translation of Clintrace software • Add new reports and GUIs to meeting Japanese regulations • Database applications: Oracle 8i • Operating systems: Windows NT servers, multiple client platforms • Hardware platforms: HP UX, IBM, DEC, Intel NT Servers • Development languages: CG++ • Project architecture: CG++ client, Oracle Database

Client Background

It is a global market leader in data man-agement solutions for regulated clinical drug trials,

It is mission-critical to the regulatory approvals, safety, and effectiveness of 90% of drugs sold around the globe.

Its customers include more than 30 of the worlds’ top 50 pharmaceutical com-panies.

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Case Study 3 - Clinical Trial Data Management System Localization Solution

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The Challenge

The current client/server architecture application could not meet the requirements of the distributed depart-ments of global companies. A web-based multiple tiers application was urgently needed. However, the new system was required to work in the similar way as the existing legacy client/server application. The new design is a multi-platform design and web-enabled commercial client-server application.

Project Highlights

DoubleBridge Solution

Solution: By providing the user with a rich featured Java Applet / JSP based front end, DoubleBridge made it possible for the user to keep using their existing experience gained from working with the legacy system for years. A smart cache mechanism was implemented to provide best performance on the client side. The new system can be deployed out-of-the-box or can be configured to meet specific needs; based on the technique that the Java Applet User Interface is dynamically generated with a Form Description XML file. The XML file can be easily customized by the end user. Back-end database fields can also be assigned in the XML file for each GUI control, which enabled the automatic data rendering through the Database Access Engine.

Benefit: There is almost no training needed for users of the legacy system to use this new system. Different organizations can customize the User Interface easily to meet their specific needs. As a result, this greatly increases the system usability. By using the three-tier application architecture, the users at different location within a global organization can operate on the same set of data concurrently. This eliminated the problem raised by the inconsistent data at different locations.

DoubleBridge implemented an XML based dynamic user interface gen-eration mechanism, which works together with the Database fields binding mechanism. The system dynamically created the rich fea-tured user interface with data from the database filled in.

Case Study 4 - Web-based Clinical Trial Data Management Solution

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Case Study 5 - Regulatory Information Portal

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Client Background

A major global pharmaceutical company with worldwide offices in all major continental states in-cluding North and South Ameri-ca, Asia, Europe, and Australia.

Employees mainly communicate with each other through phone calls and emails.

Employees go to the company’s internal and external for informa-tion they need.

Business Problems

Problem: The client company hosts a number of regulatory-related web sites. However, the web sites are using a variety of different technologies.

Impact: It is difficult to navigate among web sites as users have to remember all the web sites and guess what information is stored in where; It is difficult to manage these web sites since managing web sites with expertise in different technologies is very challenging. Also, managing redundant resources drains company time and money. Identical or similar information may be stored in different web sites. Each web site is hosted on its own dedicated hardware environment.

DoubleBridge Solution

1) Employees2) Partners3) Suppliers4) Customers

The system we built provides the following benefits to the client:

1) Business intelligence2) Collaborative functionality3) Information Access4) Content Management

Doublebridge Technologies built an Enterprise Information Portal (EIP) delivering the broadest array of re-sources, applications, communities, and content to our client. An Enterprise Information Portal (EIP) is a class of applications enabling organizations to unlock internally and externally stored information. It:1) Provides users a single gateway to personalized information2) Facilitates information access3) Works to consolidate, manage, analyze, and distribute information across and outside an enterprise

Benefits

We provided a secure, web-based interface that allows a single point of integration for and access to the client Regulatory information, applications, and services:

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Case Study 6 - Web-based Documents Management System

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Problem: Copies of the client’s regulatory filings were mostly in paper when archived. There was no digital library that hosted the archive for easy retrieval electronically.

Impact: When researches requested review of a particular filing, a separate paper copy had to be made and sent to the requester via courier. It is costly and inefficient.

Problem: There was no central registry of the regulatory filings that provided details about the submissions and the correspondence from the FDA.

Impact: Researches had to call the help desk and ask the staff to pull all filings concerning a particular drug application, in order to trace the history of the regulatory submissions and found what was looked for. It was a time consuming manual process.

Problem: Some regulatory filings were compiled electronically, even though they were sent in paper. They could be accessed online for research, but they were scattered in different enterprise systems.

Impact: Access to these available electronic resources had to be configured individually. There was no uniform security policy covering these resources. And the maintenance of the separate systems was costly.

Client Background

A major pharmaceutical company with operations in over 150 countries in the world. The company discovers, develops, manufactures, and markets leading prescription medicines for humans and animals and many of the world’s best-known consumer products.

Business Problems

DoubleBridge leveraged the Documentum document management platform and developed a scalable and extensible regulatory archival and retrieval system. The system allowed the client to search and retrieve past regulatory filings. The system also accommodated a new business process to digitize the new regulatory filings before the paper is archived.

The project was designed and delivered within 6 months. The project team employed internal expertise in Documentum and J2EE, using best practices to ensure the system is easily customized to meet new business process requirements, as well as the increasing number of users. The entire design was well documented, making the deliverable easily validated to meet the FDA compliances.

Project Highlights

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Web Client

XSL Transformation

Logic Controller

Data EJB Operation EJB

Documentum Repository

TransactionGet Data

Operation RequestData Request

Response XML

Data or Operation Request

Response HTML

The Challenges

The new system needed to provide search and retrieval of the existing filing archive. It also needed to develop a process to digitally archive the new regulatory filings when they were submitted. This is a technical implementation that also dictated a new business process.

The Approach

DoubleBridge helped the client decide on the right docu-ment management system platform to host the new sys-tem. The team worked with the business group to prioritize the requirements that provide core functionalities. The system was released to meet the most urgent business needs. Enhancements were gradually added on a rolling basis.

Solution: DoubleBridge implemented an electronic document management system that allowed the users to electronically access the digital images of the past regulatory filings.

Benefit: The turnaround time for the retrieval of research materials were cut down from days to virtually zero.

Solution: The new system had pertinent details about each regulatory filing.

Benefit: Researchers were able to search for particular regulatory filings based on a range of attributes, or by the text contained in the filing. The help desk staff can now focus on more complex research requests, instead of spending time locating paper records.

Solution: Existing electronic resources were gradually migrated into the new system.

Benefit: A uniform archive strategy. Existing systems that were kept alive solely for the purpose of hosting the electronic compilations, were retired, saving an enormous amount of software and hardware costs. User administration is centralized, leveraging Documentum’s extensive security and access control framework.

DoubleBridge Solution

Case Study 6 - Web-based Document Management System

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Case Study 7 - Web-based Audit Tracking System

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The Challenges

Target system was to be used to handle complex business logic for four different kinds of clinical trial related audits: site audit, system audit, submission document audit, and vendor audit. The project needed to be delivered in a tight time line.

The Approach

DoubleBridge sent the most experienced consultants to work with client closely. We adopted a phased approach to build a scalable and flexible database system and then implement different types of audit with minimal modification.

Solution: Provide phased based design and implementation

Benefit: The project met customer expectation and time line. The approach also reduced risk and ensured the quality of overall project

Solution: Web-based paperless process oriented system with automated and system enforced workflow.

Benefit: Reduce human errors and manual process burden of observation and audit response collection. It helps to save up to 60% of Auditors’ daily work time.

Solution: Digital sign off of audit report

Benefit: The audit reports are CFR21 Part 11 compliant. The document integration and security are ensured. Complied with FDA requirements.

Solution: Full audit trail and multi-level security control

Benefit: All modifications are tracked by the system. Combined with sophisticated authentication and authorization control, the system provides maximum security. It also provides maximum flexibility and fine-grained control for system administrator.

DoubleBridge Solution

DoubleBridge delivered a high qual-ity system within a short period of time. On site consultants provided not only quick solutions but also excellent consulting services. Our customer services and post-produc-tion support were second to none.

Project Highlights

Observation Collection Audit

Report

WATS System

Site Audit System Audit Vendor AuditSubmission Document Audit

The Auditor External Auditor Report Recipients

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Case Study 8 - Application Migration Solution for Company Acquisition

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Project Background

A large well-known Pharmaceutical company had just completed a merger with another competitor and asked DoubleBridge Technologies for a solution that would facilitate a smooth application migra-tion transition. The ownership for the legacy applications was transferred to new management at different sites.

The Challenges

Provide seamless transition of application migration in order to comply with FDA regulations and maintain business continuity. Regulatory records needed to be migrated with different data structures from a relational system to an object-oriented repository.

DoubleBridge Solutions

Solution: The project team rebuilt content in XML to provide a detailed description of each submission.

Benefits: The XML provides a detailed description of each submission. Using XSL transformation, the details were displayed in easily readable forms. In addition, the XML is text based, thus allowing a full text index to be built for each record and in turn making all legacy records fully text searchable.

Solution: The project team fit the source data into the target data structure by extending the attribute sets on the target system. The extended attribute sets were hidden from the user interface, but are searchable if the user chooses to search for legacy records.

Benfits: Application user interfaces were not modified so they remained consistent and each record had content that was fully text searchable and allowed management to view the status of submissions in real time. Provided 24x7 support, management and performance tuning.

Project Highlights

DoubleBridge was asked to map the source system to fit with the architec-ture of the target system. There were fundamental differences in data structures between the two systems. And the business required that no details should be left behind by the migration. In the end, the DoubleBridge team successfully delivered a complete migration without any loss of information. The migrated data fit into the new system easily, without the need to modify the existing user interfaces. The project was delivered within 3 months, and received high remarks from the client.

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DOUBLEBRIDGE TECHNOLOGIES

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The Challenges

Maintain application stability and add new functionality quickly in response to new client requests. Deliver a high level of application availability and support to a sophisticated global user base in a secure, cost-effective manner.

A large well-known Pharmaceutical company asked DoubleBridge Tech-nologies, Inc. for a solution to help provide global application support on a 24x7 basis. This service allowed the client to focus on core revenue generating projects and offloaded the responsibility of application mainte-nance, performance tuning, change management, ad-hoc reporting utilities development and application data update utilities development.

DoubleBridge Solution

Deploy the DoubleBridge Technologies hybrid support methodology to incorporate remote and on site consulting resources through a VPN connection from the client site to the DoubleBridge Technologies remote site. The application management repository was developed so the consultants could efficiently diagnose and take action on any potential problems. Information kept in this repository includes: change management details, concurrent version system, patch management, bug tracking, application server configuration, server OS system parameters and configuration, application related document library, backup/restore schedules. Each support event consists of several phases that were logged into this system. These phases include the following process:

Event initiating where the client requests a service reports a bug or requests a change of feature.Event identification where the DoubleBridge support person communicates with the client to identify the detail of the event.Planning to show a schedule and scope with the client.Executing debugging or changing in the testing or staging environment.Stabilizing the solution in the staging environment.Integration and User Acceptance Test.Applying the fix to the production system.

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Case Study 9 - Remote Application Support Solution

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Project Background

Troubleshooting andProblem Diagnostic

Remote Support

Client

Onsite Support Team

System Administrator

Network Architecture Expertise

Database Expertise

Application Developer