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PROGRAM COMMITTEE Shobhit Shrotriya Vice President Life Sciences Practice Accenture Raghavendra Kalmadi Director, GDSM Quintiles PROGRAM HIGHLIGHTS • The role of technology in the evolution of clinical data management • Technological innovations in clinical data management • Understanding data standards PROGRAM OVERVIEW The era of transactional delivery in history and in the changing industry landscape meeting SLAs (Service Level Agreement) is considered business-as-usual. In today’s competitive landscape, pharmaceutical companies are striving to bring their products to the market faster in a cost effective manner to enable the availability of drugs to patients at an affordable price. Therefore, it becomes quintessential for the service providers to partner with the pharmaceutical companies in this noble endeavor and start creating value by impacting their business outcomes around ‘speed to market’, ‘cost optimization’, ‘regulatory compliance sustenance’ and ‘improvement of throughput and efficiency without an impact on quality’. Clinical data management is playing a vital role in this important transformation. Lately, of the numerous dimensions that are impacting the way clinical data management is done today, technology and data standards have made a significant impact in the entire scheme of things. This conference will delve into the present and future trends of technology and data standards and the challenges faced by professionals as they navigate through this complex ecosystem. Yogesh Tambe Associate Director Quintiles Madhura Shivaram Vice President Life Sciences Practice Accenture Rajkumar Sinha Senior Director, GDSM Quintiles Mandar Ghatnekar Senior Manager Life Sciences Practice Accenture Goutham Vasudev Vice President Strategy and Business Development Clearight Infotech Ltd WHO SHOULD ATTEND Clinical research professionals involved in management and analysis of Clinical Trial Data including: • Clinical Data Managers • Clinical Database Programmers • SDTM Programmers • Biostatisticians • Statistical/Clinical Programmers • Clinical Project Managers Evolving Landscape of Clinical Data Management: Focus on Technology and Data Standards July 4, 2014 Hotel Vivanta by Taj | Bangalore, India India Office A-303, Wellington Business Park I Andheri-Kurla Road, Marol, Andheri (East) Mumbai 400 059 India All attendees will receive a DIA Certificate of Attendance at the conclusion of the event. For more information visit diahome.org/India-CDM Worldwide Offices Basel, Switzerland | Beijing, China Horsham, PA, USA | Mumbai, India | Tokyo, Japan DIA Global Center 21 Dupont Circle NW, Suite 300 Washington, DC 20036 Shobhit Shrotriya Vice President Life Sciences Practice Accenture Raghavendra Kalmadi Director, GDSM Quintiles PROGRAM CHAIRS Balaji C. L. Managing Director Life Sciences Practice Accenture Suresh Ramu CEO and Co-founder Cytespace KEYNOTE SPEAKERS SPEAKERS

Evolving Landscape of Clinical Data Management market’, ‘cost optimization’, ... and efficiency without an impact on quality’. Clinical data management is playing a vital role

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PROGRAM COMMITTEE Shobhit ShrotriyaVice PresidentLife Sciences PracticeAccenture

Raghavendra KalmadiDirector, GDSMQuintiles

PROGRAM HIGHLIGHTS

• The role of technology in the evolution of clinical data management

• Technological innovations in clinical data management

• Understanding data standards

PROGRAM OVERVIEW

The era of transactional delivery in history and in the changing industry landscape meeting SLAs (Service Level Agreement) is considered business-as-usual. In today’s competitive landscape, pharmaceutical companies are striving to bring their products to the market faster in a cost effective manner to enable the availability of drugs to patients at an affordable price. Therefore, it becomes quintessential for the service providers to partner with the pharmaceutical companies in this noble endeavor and start creating value by impacting their business outcomes around ‘speed to market’, ‘cost optimization’, ‘regulatory compliance sustenance’ and ‘improvement of throughput and efficiency without an impact on quality’. Clinical data management is playing a vital role in this important transformation. Lately, of the numerous dimensions that are impacting the way clinical data management is done today, technology and data standards have made a significant impact in the entire scheme of things. This conference will delve into the present and future trends of technology and data standards and the challenges faced by professionals as they navigate through this complex ecosystem.

Yogesh TambeAssociate Director

Quintiles

Madhura ShivaramVice President

Life Sciences PracticeAccenture

Rajkumar SinhaSenior Director, GDSM

Quintiles

Mandar GhatnekarSenior Manager

Life Sciences PracticeAccenture

Goutham VasudevVice President

Strategy and Business Development

Clearight Infotech Ltd

WHO SHOULD ATTEND

Clinical research professionals involved in management and analysis of Clinical Trial Data including:

• Clinical Data Managers• Clinical Database Programmers• SDTM Programmers• Biostatisticians• Statistical/Clinical Programmers• Clinical Project Managers

Evolving Landscape of Clinical Data Management: Focus on Technology and Data Standards July 4, 2014 Hotel Vivanta by Taj | Bangalore, India

India OfficeA-303, Wellington Business Park I

Andheri-Kurla Road, Marol, Andheri (East) Mumbai 400 059 India

All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.

For more information visit diahome.org/India-CDM

Worldwide OfficesBasel, Switzerland | Beijing, China

Horsham, PA, USA | Mumbai, India | Tokyo, Japan

DIA Global Center21 Dupont Circle NW, Suite 300

Washington, DC 20036

Shobhit ShrotriyaVice President

Life Sciences PracticeAccenture

Raghavendra KalmadiDirector, GDSM

Quintiles

PROGRAM CHAIRS

Balaji C. L.Managing Director

Life Sciences PracticeAccenture

Suresh RamuCEO and Co-founder

Cytespace

KEYNOTE SPEAKERS SPEAKERS

2

DAY 1 | CONFERENCE AGENDA FRIDAY, JULY 4, 2014

9:00-9:30 am REGISTRATION

9:30-9:45 am WELCOME

Shobhit ShrotriyaVice PresidentLife Sciences PracticeAccenture

9:45-10:15 am KEYNOTE ADDRESS

Interplay of Technology and Data Standards in CDMSuresh RamuCEO and Co-founderCytespace

10:15-10:45 am TEA BREAK

10:45–1:00 am IMPACT OF TECHNOLOGY ON CDM

10:45-11:30 am Recent Innovations in Technology Solutions for Clinical Data Management

Mandar GhatnekarSenior ManagerLife Sciences PracticeAccenture

11:30 am-12:15 pm The Future Just Happened: How Recent Innovations and Advances in Ubiquitous Computing and Human Networking Influences Clinical Data Management

Yogesh TambeAssociate DirectorQuintiles

12:15-1:00 pm Technology in CDM – An Enabler or a Deterrent?

Goutham VasudevVice President Strategy and Business DevelopmentClearight Infotech Ltd

1:00-2:00 pm LUNCH AND NETWORKING

2:00-2:30 pm KEYNOTE ADDRESS

Changing Trends in CDM and Outsourcing Balaji C. L.Managing DirectorLife Sciences PracticeAccenture

2:30–5:15 pm DATA STANDARDS: CDASH, SDTM, ADAM — TYING THE KNOT

2:30-3:15 pm Integrated Standards through Comprehensive Synergies between CDASH, SDTM and ADaM

Madhura ShivaramVice PresidentLife Sciences PracticeAccenture

3:15-4:00 pm CDASH, SDTM and ADAM — Fixing the Puzzle

Rajkumar SinhaSenior Director, GDSMQuintiles

4:00-4:30 pm TEA BREAK

4:30-5:15 pm TBC

TBC

5:15-5:30 pm VOTE OF THANKS

Raghavendra KalmadiDirector, GDSM Quintiles

5:30 pm CONFERENCE ADJOURNED

FRIDAY, JULY 4, 2014

2014 DIA INDIA EVENTS

TO BE ANNOUNCED

Conference on GenericsAhmedabad

OCTOBER 16-18

DIA INDIA 2014: 9th Annual ConferenceMumbai

For more information, please contact: Manoj Trivedi, Senior Manager Marketing and Program Development tel: +91.22.6741.7625 | cell: +91.98.1977.7493 [email protected]

CANCELLATION POLICY:  On or before JUNE 19, 2014Cancellations must be in writing and received by June 19, 2014. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

REGISTRATION FEES

Registration fee includes refreshment breaks, luncheons.

Join DIA now to qualify to save on future events and to receive all the benefits of membership. To see all the benefits of DIA membership, visit www.diahome.org and click on Membership.

Upon cancellation, the administrative fee that

will be withheld from refund amount is:

FULL MEETING CANCELLATION All refunds will be issued in the currency of original payment

75% of the Delegate fee

PLEASE PRINT ALL INFORMATION CLEARLY

Degrees:  q Dr.  q Mr.  q Ms.

Last Name (Family Name)

First Name

Job Title

Affiliation (Company)

Address (Please write your address in the format required for delivery to your country.) q Business Address q Home Address

Postal Code City State Country

Telephone Number Fax Number Mobile Number

email (Required for confirmation) Signatory

Payment contact person’s Full Name Telephone Number email

A limited number of student registrations are available.A student is an undergraduate/graduate who can document enrollment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment. TOTAL AMOUNT: __________________

ORGANISATION PAN No.: __________________

REGISTRATION TERMS AND CONDITIONS: Registration form should be duly filled, signed by the authorized person. You are requested to email the duly filled and signed Registration Form first and then courier/mail

it along with registration fees on or before 5 working days of this conference.

PAYMENT INFORMATIONCompleted form, along with draft/cheque made payable to DIA (India)

Private Limited should be sent to:

Bhavesh Vora | Senior Executive Accounts

[email protected]

Drug Information Association

A- 303, Wellington Business Park 1, Andheri Kurla Rd.

Marol Naka, Andheri East, Mumbai 400059 INDIA

tel: +91 22.6523.0676 | cell: +91 98.2097.2630

PLEASE CONSIDER THIS FORM AS AN INVOICEEvolving Landscape of Clinical Data Management: Focus on Technology and Data Standards

Meeting I.D. # 14661 | July 4, 2014 | Hotel Vivanta by Taj | Bangalore, India

VENUE DETAILS Hotel Vivanta by Taj M G Road, Bangalore, 41/3 Mahatma Gandhi Road Bangalore 560 001 Karnataka, India www.vivantabytaj.com

ROOM RESERVATION CONTACT Dibyanjana Chowdhury, Catering Sales Supervisor cell: +91 87.9200.9006 | direct: +91 80.6660.4239/4240 tel: +91 80.6660.4444 | fax: +91 80.6661.4444 [email protected]

CONTACT

Manoj Trivedi Senior Manager, Marketing and Program Development

DIA (India) Private Limited cell: +91 98.1977.7493 [email protected]

DELEGATE REGISTRATION FEE

BASIC RATE SERVICE TAX TOTAL

Industry 5000 618 5618 INR

Academia/Government 3000 371 3371 INR

Student 2000 247 2247 INR

Please check the applicable category:   

q Academia  q Industry  q Student

Kanchan Patel, Senior Manager, Operations DIA (India) Private Limited cell: + 91 98.2062.1844 [email protected]