Healthcare Services Group including Clinical Trial Services Exclusively through GCP-MB, LLC

Contents

Corporate Background IDS Infotech’s Healthcare Services 3 5 Our Capabilities 17 Select Case Studies 20 IDS Infotech’s Best Practices 28

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Corporate Background

Twenty years of successful management in IT and Business Process Outsourcing

• Established in 1989, IDS Infotech employs over 1200 people • Offices in 6 locations globally • Located in Chandigarh, Mohali and New Delhi (Noida), India, IDS is one of the largest Back Office Processing Units in North India • Subsidiary - IDS America, Inc. founded in 2004 with offices in NY and Virginia • Support Office in the UK with additional Multi location facilities in India as a part of Business Continuity Plan (BCP) • IDS Infotech uses a seamless global delivery network and extensive domain expertise to help any type of business achieve rapid and sustainable cost savings, improve cash flow and drive top-line growth • IDS applies the latest technological advances, a highly educated workforce and total customer commitment to provide cost-effective solutions to our clients around the world

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Global Service Areas: Our experts successfully migrate processes —with quantifiable results —in the following service areas

IDS Infotech Healthcare

• Provides complete healthcare business solutions around the globe • Caters to provider, payer, and pharmaceutical segments • Services include clinical data management, medical transcription, accounts receivable management, electronic medical records, insurance & customer care • HIPAA compliant and ISO 9001:2000 certified

Engineering and Design

• Caters to diverse industry verticals such as automotive, aerospace, and machinery • Services include Engineering Design, Engineering Analysis, CAD services, and Manufacturing Support • Relationship management by local (EU & USA) engineering personnel • Domain & sub-domain expertise in all industry verticals • Value Analysis/Value Engineering across the product life cycle

Legal Services

• Offers Client dedicated teams, Six Sigma processes and leading edge world class technology • Specializes in ESI processing, Document review, legal research, and paper discovery • Caters to corporations, law firms, and e-discovery Alliances • Expert team includes certified ESI processors, Attorney reviewers, project managers, and litigation analysts

Content Management and Publishing Solutions

• Specializes in content management and pre press services such as data capturing, data conversion, typesetting, and document scanning • Caters to the production and conversion needs of publishers, knowledge service providers, professional organizations and universities • Services range from editing books to academic and financial publications involving high volumes of mathematical and tabulated data

Software Services

• Caters to diverse sectors, including Retail, e-Commerce, Network security, Healthcare, Media and Entertainment, and ISVs • Services include application development and maintenance, Technical helpdesk, QA and testing services • Expertise in technologies such as .Net, Java, LAMP, iPhone and in designing and developing Rich Internet applications

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IDS Infotech’s Healthcare Services

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We offer end-to-end Healthcare services across the entire value chain, thus adding higher value to our clients

Medical Transcription Patient Records Management Charge Processing Patient Record Secure storage and retrieval IDS Healthcare Solutions across the Value Chain Appointment Scheduling Insurance Authorisation and Pre-cert Patient Call Answering Clinical Research Data Management Billing and Claims Receivable follow-up and Collections Coding

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Our healthcare services

Provider Segment Medical Transcription Services (MTS) Account Receivable Management (ARM) Medical Record Digitization / Electronic Medical Records (EMR) Healthcare Services Payer Segment Insurance Services Group (ISG) Pharmaceutical Services Clinical Data Management Direct-To-Customer Services

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We cater to the provider, payer and pharmaceutical developer segments

Clinical Data Management (CDM)

Clinical Data Management and SAS Programming services to Pharmaceutical Research Companies through GCP-MB, LLC, providing both clinical and non-clinical services

Direct-To-Customer Services

Drug Information Services, Product Complaint Services, Drug Ad Response Hot line, Market Research, Patient recruitment and screening for Clinical Research

Account Receivable Management (ARM)

Appointment Scheduling, Patient Registration in Practice Management System, Patient coverage and Benefits verification, Coding, Charge Entry, Claim submission, Payment posting, Denial/Rejection Analysis, A/R Follow-up, Provider credentialing, and pre-adjudication

Medical Transcription Services (MTS)

Medical Transcription Services to US Hospitals and MTSOs

Medical Record Digitization / Electronic Medical Records (EMR)

Online patient registration, medical template customization, data conversion dumping from old system to new system, medical records day-forward conversion, and medical records backfile conversion for EMR system

Insurance Services Group (ISG)

Data Entry of insurance claims for insurance companies and TPAs

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Our experience in Clinical Data Management (CDM)

• Clinical Trial Experience in Depression, Oncology, Psoriasis, Rosacea, Periodental disease, Lupus, HHID, Liver failure, Asthma, COPD, Hypertension, Analgesics, etc. • Dedicated experienced project manager for each account with over seven years of experience • Team of twenty people who have expert knowledge in medical terminology and coding methods with average experience of 3-4 years • Processing at an average 1000 records per day per person for clinical and non-clinical projects • Successfully delivered several complex projects well within expected budget and turn around time • Fully HIPAA Compliant process

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Our Process Flow Chart for Clinical Research Management

Version 1.1

IDS INFOTECH LTD 09/01/2009

SPECIFICATIONS RCV’D FOR NEW PROJECT PROJECT MANAGER READS SPECIFICATIONS ANY QUERY NO YES PROJECT MANAGER SENDS QUERY TO CLIENT USING ISSUE TRACKER CLIENT’S RESPONSE RCV’D

PRODUCTION

YES NO CRFs PROCESS>=20% OF RECEIVED NEW PATIENTS’ CRFs NEW PATIENTS’ CRFs ARE ASSIGNED TO TEAM MEMBERS BY TL/SPA TL/SPA PREPARES DAILY PRODUCTION SHEET QUERY ARISES AT THE TIME OF PROCESSING PROJECT MANAGER SENDS QUERIES THRU MAIL TO THE CLIENT QUERIES RESOLVED BY CLIENT PROJECT MANAGER INFORMS TL/SPA NO ANY FURTHER QUERY YES PROJECT MANAGER SENDS CONFIRMATION MAIL TO CLIENT TL/SPA ANNOUNCES DECISION ON FLOOR PROJECT MANAGER DETERMINES RESOURCE REQUIREMENTS FOR THE PROJECT TL/SPA GIVES TRAINING TO TEAM MEMBERS TL/SPA CHECKS FOR NEW PATIENTS’ CRFs ON CLIENT'S SERVER TRAINEES FILL TRAINING ACKNOWLEDGEMENT FORM IDS INFOTECH LIMITED Confidential QA PROCESS STARTS ALL NEW CRFs THRU QA PROCESS YES NO QA SAMPLING PROCESS STARTS NO QA SAMPLING PROCESS IS DONE YES CLIENT IS INFORMED BY EMAIL Clinical Data Management

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Our experience in Direct-To-Customer Services

Drug Information Services Product Complaint Services Drug Ad Response Hot line Market Research For Patients For Physicians

• Assist patients in better understanding the drug by answering their questions on drug usage, side effects and any other issues • Create database of prescribers, users, target patients • Serve as help desk for consumers, information collection desk for marketing division • Serve as the first level resolution center, answering questions around: appropriate therapy for specific patients; adverse reactions to drugs; efficacy of drugs; drug interactions; intravenous additive incompatibilities; biopharmaceutic and pharmacokinetic parameters of drugs; dosing in renal failure; appropriate therapy for a disease state; identification of foreign drugs; and information on new drugs • Log in the received complaint • Filter the complaint into critical or non-critical categories • Address non-critical complaints and escalate critical complaints as per protocols set • Follow-up on the resolution with the complainant This hotline can be used for any of the following purposes: • Answer clinical or Benefit questions • Collection of Patient interest data • Clinical Counseling • Product education – for the product on active promotion • Collect Socio Economic Statistics • Conduct patient Satisfaction survey’s • Conduct patient / physician Demographic survey

Patient Recruitment and Screening for Clinical Research

• Screen the patients for recruiting in clinical trials based on the inclusion and exclusion criteria

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We managed over 50 clinical and non-clinical projects Clinical Projects

Daiichi Sankyo Vicept BMS Novartis AZ-NXY Genzyme Astellas GPC Forest AMI Centocor AtheroGenics ARCA Hemispherx Allergan Eisai Astellas Shire Duramed NeurogesX AZ-Seroquel Al Pharma Pain Therapeutic AZ Crestor ALS (Advance Life Science) Premier Research Arca Biopharm Galderma

Non-clinical Projects

Pain Therapeutics Mits Acceleron Battelle ALS (Advance Life Science) Actelion Premier ARCA Eisai Ligand Pharmacyclics Hyperion DSPA PGx Health Tracon Nuvo Premier Research Prolexys Synta Auxilium Novartis EndoCeutics Xanodyne Poniard Pharmasset TMC Cangrelor Pacira Lux Biosciences

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Select Case Studies

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Case Study for Clinical Research Management

Client background Project background

The client is one of the largest global Clinical Research Organizations having footprint in 18 countries. Services support the entire drug development process cycle. Service offerings range from preclinical testing to clinical trials management (Phase I to Phase IV) thus assisting pharmaceutical and biotech companies of all sizes to fulfill their research and development, clinical trial, regulatory and marketing support needs.

Data entry of Case Report Forms (CRFs), as part of Clinical Trials Phase II and III, was expensive, time consuming, and created a bottleneck in proceeding to the next stages of review for the client. CRFs were being entered by the client at the client’s own production facilities. The client was looking for a way to eliminate the bottleneck resulting from the time consuming, low end 1st and 2nd pass data entry of CRFs

Challenges faced by our Client

The client, being a global operator, has a centralized online database and the service provider needed to have 24-hour access to this database To eliminate the bottleneck, the client established a minimum turn around target of 21 days to process a backlog of 11,500 forms Being a Phase III clinical study requisite, audit trails were required to ensure client confidentiality The client utilized Oracle Clinical, which required specific application knowledge and operating skills

Our Solution

IDS Infotech established fire walled VPN connectivity between the customer’s Oracle Clinical Database in the US and our operational facility in India All 11,500 forms processed by IDS Infotech in 7days. Post processing efforts by the client was reduced significantly, as all manual discrepancies were resolved at 2nd pass entry A secure, US based server was used to transfer scanned CRFs (images) to India. All processes strictly followed the required SOPs dictated by the client • • • IDS Infotech core team working on this project was trained by CRO in UK on Oracle Clinical (OC) A T3 module created by the core team, with assistance from the client, allowed efficient transfer of OC skills to India based data entry personnel Additional on-line training by teleconference and Web Cast was imparted to facilitate knowledge transfer, resulting in OC expertise with minimal investment

Benefits to Client

•

Accuracy:

The accuracy of the delivered work was on average 98.5% •

Turn Around Time (TAT):

The agreed upon TAT by the client to receive the indexed CRFs was 21 days whereas IDS Infotech delivered the same within 7 days as we have dedicated team at IDS Infotech to do CRF indexing exclusively. Currently the team is working with a TAT of three days and meeting the same consistently. •

Cost saved up to 40%:

By using IDS Infotech personnel who are well trained to provide best of services there is no capital investment on infrastructure and resources from the client’s side, the total reduction in the cost of the client is as high as 40 %. We were able to provide solution to the client to reduce the costs involved in handling multiple databases as against a single database.

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Case Study: Our approach

Phase 1: Process Assessment Phase 2: Implementation of Services Phase 3: Quality Analysis

• • • • Client visit: IDS Infotech team visited the client’s site in the UK for three months in order to understand their process The client also visited IDS Infotech in India and performed audit of the facility for the capability testing to perform clinical research related work • We were compliant with all the requirements Established Clinical Data Management (CDM) processes at IDS Infotech Trained the IDS Infotech team • • • • Gained access to client’s application and database through secured user IDs and passwords Provided the following services for the CRFs Phase I, II and III of the clinical trials • • Indexing First pass • • Second pass of the CRFs Quality Management of the studies Performed data indexing of all the above mentioned studies, which is the step two in data entry of Phase I clinical trials • The entire team at IDS Infotech was trained online for data indexing Conducted Quality Management: QM is the final step in Clinical Database check. The main objective of QM was to ensure that the database is an accurate reflection of the CRF and the data review is appropriate and consistent with study guidelines and conventions • Post completion of data entry, released the CRFs, which in turn were saved in the client database for the Quality Analysis at their end

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Case Study for Clinical Research Management

Client background

Our client is a leader in the electronic transformation of clinical R&D. They offer a suite of regulatory, clinical, process and IT solutions. They have a proven record of delivering innovative solutions to leading biotech and pharmaceutical companies.

Our Service Offerings

• • • Received Case Report Forms (CRFs) and Data Clarification Forms (DCFs) for book marking and linking from the client The overview of steps is as follows: • • • • Case Report Forms (CRF) Book marking Case Report Forms (CRF) Linking to DCF Quality Check 100% Second stage Random Sampling QA process Assisted the client in both clinical and non-clinical projects • Managed over 50 clinical and non-clinical projects for the client

Project Achievements Description

Total number of client projects: Total number of files (PDF): Total number of pages (CRF): Total number of DCF / Bookmarks: Total number of Queries resolved / Links:

Volumes handled for Clinical projects

68 18306 2132534 173030 DCF 215917 queries resolved

Volumes handled for Non-Clinical projects

30 1789 410954 169748 bookmarks 124091 links

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Case Study for Clinical Research Management

Client background

Our client is dedicated to serving the Pharmaceutical, Biotechnology and CRO Industries by developing and supporting state of the art software and services designed to facilitate a more efficient, effective and timely capture, distribution and analysis of clinical data from paper or imaged CRF forms. It offers the possibility of electronic data capture from paper or imaged CRF, including full verification, validation, data management and clean-up.

Our Service Offerings

• • • • • Image Verification for CRFs • Verify the received images against online client data Data Entry – 1st and 2nd Pass Quality Check • Check all records100% by comparing the data entered in the 1 st and 2 nd pass to ensure quality SLA Field Data Clarification Forms (FDCFs) • Data entry of DCFs including query resolution Statistical Analysis Systems (SAS) in Clinical trials • Complete analysis of the patient data deploying SAS tools

Statistical Analysis Systems

The following steps are followed for performing Statistical Analysis in Clinical Trials

Import external data Data validation Data analysis Report generation

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Case Study for Insurance Services Client: Third party Administrator

Client

The client is a leading Third Party Administrator and principally engaged in administering self funded healthcare plans for 300+ lives, single or multi-site employers and back shop claim processing. The client is responsible for the administration of an employer’s medical benefit plan. They are also responsible for printing and providing ID cards and medical benefit plan booklets, as well as processing and arranging for payment of medical claims.

Project Background

The client was looking for a partner who could help them to perform the digitization of about 3000 medical claims per day. The client wanted to engage cost effective service providers which can meet the expected TAT of 12 hour for these claims with at least 99% accuracy. IDS conducted detailed study of their requirements and undertook the pilot for the project.

Challenges faced by Client

The major challenges were to : • • • Cut on the paper printing cost. Output in HIPAA 837 format. 3). Achieve the turnaround time with the expected 99% accuracy levels.

Our Solution

• The IDS in-house training team developed a fast track training program for the data entry personnel, and ramped up staff into its dedicated facility to the required number on an accelerated pace.

• Key processes were optimized to maximize productivity from the staff and all the team members were adequately trained and tested before putting them on the project.

• To meet the TAT requirements of our client, a special application was designed where we could open the client input files on the upper half of the screen and index the data in our application in the lower half of the screen. Also this application recorded all the entries made and auto-populated the recurring data. This saved a lot of time and increased the productivity of our team members. Also, we did not have to print all the input data received from the client.

• 100% quality sampling was done during the initial 2 weeks to understand the weak areas of the team and retraining sessions were conducted to improve on them. • Daily feedback sessions with the client were conducted during the pilot phase to ensure customer satisfaction. •

Benefits to Client

Client appreciated the performance during the pilot phase. They were particularly happy with the quick turnaround and the quality work.

• Client gained the confidence on IDS, and they doubled up the volumes in 45 days.

• Client started seeking solutions from IDS wherever they required our services that required any special treatments.

• Cost Saving: The outsourcing concept resulted in huge cost savings to the client as otherwise they were getting the digitization done domestically which incurred heavy costs compared to the off-shore digitization.

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IDS Infotech’s Best Practices

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We differentiate ourselves by following best practices in all our processes

Security and Compliance Project Management Global client requirements

Our best practices

Quality and SLA requirements HR policies

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Our best practices We follow a zero-tolerance security and compliance policy

Confidentiality & Data Security Personnel Level

Each employee is trained on the Confidentiality and monitored for any data exchange, either physical or virtual

Technology Level

We have all the necessary security features to ensure all data is not only protected, but stored with a Business Continuity Plan. We have a mirror site with NTT Vario with full fledged secure servers and systems

HIPAA Physical Security

All locations secured by Security and Electronic controls

Personnel Level

All IDS Infotech employees in our Healthcare division undergo a HIPAA Compliance training Program and evaluated. Those that pass only can work with clients

Technology Level

We request for a HIPAA compliance checklist from the client. Check list signed off once technology requirements are met

Contract Level

All locations secured by Security and Electronic controls

Compliance Officer

Dedicated Compliance officer for HIPAA

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Our best practices We understand Global Client requirements

• No Downtime – Guaranteed 24x7 operations • 100 percent link redundancy including Last mile local loop • 5 Mbps Bandwidth with VPN - Easily scalable • Facility wide and inter facility level BCM • Data security audit process; ISO 270001 company; 100% data back up • Own US based secured, dedicated FTP, email and web server • Client confidentiality - NDA; firewalls at gateway/ remote server

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Our best practices Our staff and HR policies have yielded lower than industry attrition rates

• Strict adherence to Indian government rules for employee welfare • Staff covered under group medical insurance scheme • Ethical workplace practices • No employee below 18 years of age • Structured reward/recognition and performance appraisal system • Employee work place as per international standard • Induction and on-going functional training • Continuous feedback and improvement mechanism

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Our best practices We guarantee Quality and Turn Around Time (TAT) SLA requirements

• ISO 9001 certified QMS • Identify KRA in joint review with client • Process based, data intensive approach based on DMAIC • Well documented SOP’s for maintaining project quality • Each SOP with clearly defined tasks and control points • Each task staffed with trained staff • Each task with well defined performance and quality metrics • • 100% QA to client. No dispatch to client without Quality Check MIS to track and deliver TAT – within 24 hours or more

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Our best practices We follow a least pain to the client, project management based migration approach

• Establish Team Charter; understand business rules • Process a sample; analyze client requirements • Translate in terms of project resource requirements • Present solution costing to client; sign SLA • Setup process requirements • Phased approach: run a Pilot; tune process; incorporate improvements; continue phased ramp up till ownership of full volume; MIS system for reporting & communication

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We have been certified for providing top-most quality while maintaining security and confidentiality ISO 9001:2008 ISO 27001:2005 HIPAA COMPLIANT AS 9100:2001

QUALITY

The ISO 9001:2008 standard provides a

tried and tested framework

for taking

a systematic approach

to managing an organization's processes so that they consistently turn out product that satisfies customers' expectations.

SECURITY

ISO/IEC 27001 formally specifies a management system that is intended to bring information security under explicit management control. Being a formal specification means that it mandates we meet specific requirements.

CONFIDENTIALITY

HIPAA establishes standardized mechanisms for electronic data interchange ( EDI ), security, and confidentiality of all healthcare-related data. The Act mandates security mechanisms to ensure confidentiality and data integrity for any information that identifies an individual.

QUALITY

The standard adheres to all the requirements of ISO 9001:2000 plus additional requirements for the aerospace industry.

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Safe Harbor Privacy Principles

IDS consider protecting the integrity and privacy of every confidential information as a crucial part of our services. We have strict directives for Safe Harbor Privacy principles and our security and policies are revised from time to time for better scrutiny and privacy maintenance. With every such amendment, changes are made in the processes and the technology so as to make both compliant.

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Our Clinical Trials support services are offered exclusively through GCP-MB, LLC. For other services we can be contacted at…

USA Office IDS America Inc.

1501 Broadway, 12 th New York-10036 Floor Tel : (+1) 734 276 5260 Fax : (+1) 703 462 5459 www.idsil.com India Office IDS Infotech Ltd.

C-138, Phase VIII, Industrial Area, Mohali, India. Tel : +91 (172) 509 1601/602 Fax : +91 (172) 509 8475 Europe Office IDS Infotech Ltd. Croy 7 5653 LC Eindhoven The Netherlands Tel : +31 (0) 40 256 16 02 Fax : +31 (0) 40 256 11 05

This document details information and methodology of a confidential nature given by IDS Infotech. No part of this document can be used, reproduced or disclosed to any third party without the written prior consent of IDS Infotech.

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