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Page 1: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica

DESTINATIONORLANDO

Page 2: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica
Page 3: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica

3SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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TABLE OF CONTENTS

CONFERENCE HIGHLIGHTS ............................................................................................................................................................................. 4

SCDM MOBILE APP .............................................................................................................................................................................................. 5

NETWORKING OPPORTUNITIES ..................................................................................................................................................................6

SCDM FAIR ...............................................................................................................................................................................................6

OPENING RECEPTION .......................................................................................................................................................................6

SCDM NETWORKING RECEPTION (BLACK & WHITE NIGHT) .......................................................................................6

MEDIA PARTNERS .................................................................................................................................................................................................6

PRE-CONFERENCE FUNCTIONS .................................................................................................................................................................... 7

A DATA MANAGER’S GUIDE TO RISK BASED MONITORING 2017 ............................................................................... 7

PREPARING DATA FOR FDA SUBMISSION ............................................................................................................................... 7

LEADERSHIP FORUM ..........................................................................................................................................................................................10

KEYNOTE PRESENTATION ...............................................................................................................................................................................12

REGULATORY PANEL..........................................................................................................................................................................................14

EDUCATIONAL SESSIONS ...............................................................................................................................................................................15

POSTER PRESENTATIONS .................................................................................................................................................................................16

NEXTGEN TECHNOLOGY INNOVATION AWARD (TIA)...................................................................................................................16

SPONSORS ..............................................................................................................................................................................................................18

EXHIBITOR LIST .....................................................................................................................................................................................................19

PRODUCT SHOWCASES ..................................................................................................................................................................................20

EXHIBIT HALL BINGO CARD .........................................................................................................................................................................22

GREEN MEETING INITIATIVES .......................................................................................................................................................................22

WELCOME TO ORLANDO! ............................................................................................................................................................................23

ABOUT OUR HOST CITY ...............................................................................................................................................................23

LOCAL ATTRACTIONS .....................................................................................................................................................................23

TRAVEL & ACCOMMODATION....................................................................................................................................................................23

AIRPORT..................................................................................................................................................................................................23

ACCOMMODATION .........................................................................................................................................................................23

SCDM 2018 ANNUAL CONFERENCE..........................................................................................................................................................25

Page 4: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica

4SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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SCDM LOOKS FORWARD TO WELCOMING YOU IN ORLANDO

CONFERENCE HIGHLIGHTS

• Discover more about the Educational Sessions in the SCDM 2017 Annual Conference program, steered by our devoted Conference Co-chairs.

• Join the interactive Roundtable Sessions, led by CDM industry influencers and thought leaders.

• Hear the latest updates on current key topics concerning clinical development and the data management discipline from our experts during the Panel Discussion Sessions.

• Train yourself and learn the essential skills of preparing and conducting data in different clinical research areas with the Preparing Data for FDA Submission Pre-Conference Workshop.

• Learn what you can do to help your organization manage risk and be Data Driven from our distinguished Subject Matter Experts during the A Data Manager’s Guide to Risk Based Monitoring 2017 Pre-Conference Workshop.

• The SCDM Data Innovation Task Force is happy to present the 2017 NextGen Technology Innovation Award. Winners will showcase their products during a dedicated plenary session and you will have a say in who the winner is.

• Visit the Exhibit Hall and meet our Partners and Exhibitors to experience new products and innovative industry technology.

• View SCDM’s Poster Presentations on Monday, September 25 & Tuesday, September 26.

• Get involved in one of the many networking opportunities available during the conference.

• Find out more about SCDM activities during the SCDM sessions of interest on topics such as the CCDM Exam, GCDMP, etc.

The SCDM 2017 Annual Conference is just around the corner.

SCDM invites you to participate in the largest international educational event for Clinical Data Managers and related professionals. This year, the SCDM 2017 Annual Conference will take place at the Grande Lakes Orlando, on September 24-27. The conference venue will host all educational sessions, exhibition and social events to ensure that you make the most of your SCDM experience.

We look forward to welcoming you there!

Grande Lakes Orlando 4040 Central Florida Pkwy Orlando, Florida 32837, USA

Register Now!

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STAY TUNED - THE SCDM MOBILE APP WILL BE LAUNCHED SHORTLY

We are proud to present our all-new mobile application allowing you to access the most updated conference information at the tips of your fingers.

Now it is easier than ever to...

Learn more about the program and session chairs/ speakers

Build your own agenda to make the best out of the conference

Find your way around the conference venue using the interactive floorplan

Discover this year’s exhibitor listing

Engage during the sessions with the live polling and Q&A features

Rate the sessions’ content and speakers

Network with your peers

Get live access to key information that will make your experience memorable

SCDM goes digital in the quest for a better conference experience!

CO-SPONSORED BY

3find your inspiration during 3 outstanding plenary sessions

Educational Opportunities

Who will attend?

2roundtable sessions

3SCDM sessions of interest

6product showcases

5panel discussions

+60exhibiting companies

learn valuable skills and discover new tools during 24 educational sessions

24

gain in-depth knowledge with 3 pre- and post-conference functions

3

+20countries represented

among attendees

+110international speakers

+650CDM professionals

unlimited networking opportunities

14presentation sessions

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6SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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SCDM FAIR

Sunday, September 24 | 05:00 PM – 08:00 PM

Location: Palazzo Ballroom Foyer

Join us for the second edition of the SCDM Fair. This session gives conference attendees the chance to meet members of the SCDM Board and SCDM Committees & Task Forces, while networking with fellow colleagues!

OPENING RECEPTION

Sunday, September 24 | 06:00 PM – 08:00 PM

Location: Palazzo Ballroom (Exhibit Hall)

Start your conference experience with the Opening Reception.

Meet the top industry leaders during this excellent networking opportunity. Appetizers and refreshments will be served in our comfortable exhibition facilities.

SCDM NETWORKING RECEPTION BLACK & WHITE NIGHT

Tuesday, September 26 | 07:00 PM – 09:30 PM

Location: Grande Lakes Da Vinci Terrace & Lawn (outdoor space)

As spaces are limited for this exclusive ‘Black and White Night’ registrations will be managed on a first-come, first-served basis. Do not miss this opportunity and register today.

Dress Code: Black & white, be creative!

Fee: $80 per person

CO-SPONSORED BY

MEDIA PARTNERS

WE WOULD LIKE TO THANK OUR MEDIA PARTNERS FOR THEIR CONTINUED SUPPORT.

Register Now!

NETWORKING OPPORTUNITIES

“This is a great event to connect with what is going on in the industry, meet old colleagues and even those from your own company face to face. Plenty to discuss, learn and take away. A good event to develop DM knowledge and skills.”

Erica Sage, Associate Director, Clinical Data Management, inVentiv Health Clinical

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7SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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PRE-CONFERENCE WORKSHOPA DATA MANAGER’S GUIDE TO RISK BASED MONITORING 2017

Sunday, September 24 | 08:00 AM – 12:00 PM

Location: Siena I & II

LEADER: • Debra Jendrasek, Vice President, Strategic Development Partner,

Chiltern International, Inc.

SPEAKERS:• Kristin Mauri, Global Head Risk Based Monitoring, BioClinica, Inc.• Olgica Klindworth, AD, Data Analytics, PPD• Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and

Company

SESSION DESCRIPTION:The four presenters in this workshop are Subject Matter Experts within their organizations for Risk Based Monitoring. While Risk Based Monitoring is not new to the industry, for some Sponsor and CRO companies, there are lots of challenges to getting started. For small to mid-sized firms, straying from traditional monitoring might seem daunting. This team of experts will help lay out the key concepts of Risk Based Monitoring, what you need to understand as Data Managers in a CRO or a Sponsor organization and then what you can borrow (or re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven.

Chiltern, BioClinica and PPD are 3 of the 11 CROs that make up the CRO Forum. The Risk Based Monitoring Workstream of the TransCelerate organization is just one of the workstreams that the CRO Forum contributes to. Eli Lilly is one of the founding members of TransCelerate and contributor to the RBM materials available in the industry. This session will provide the audience with different CRO and Sponsor perspectives on supporting and working within a Risk Based Model.

LEARNING OBJECTIVES:• Gain an understanding of the terminology, acronyms, and definitions

of widely used terms under the Risk Management umbrella• Be able to identify where Data Management input is required for a Risk

Based model to a clinical trial• Understand how to best work with a CRO/ Sponsor within a Risk

Based model• Acquire a basic understanding of RBM and how the role of data

manager can support organizational efforts in Risk Based monitoring

CDM Certification Competencies: CRF Design, Data Query Processing and Tracking, Clinical Trials Processes, Roles and Responsibilities, SAE Reconciliation and Safety Review, Data Management Plans, CRF Tracking and Communication of Data Trends, Clinical Database Design/ Relational Data Bases, Data Base Lock Procedures

Target Audience: Data Management or Biometrics functional areas representatives that need an understanding of Risk Based Monitoring and the ICH E6 (r2) updates and how these items affect their role within a clinical trial.

Continuing Education Credits: SCDM is authorized by IACET to offer 0.4 CEUs for this program.

PRE-CONFERENCE WORKSHOPPREPARING DATA FOR FDA SUBMISSION

Sunday, September 24 | 01:00 PM – 05:00 PM

Location: Siena I & II

LEADER:• Dave Izard, Senior Director, Clinical Data Standards, Chiltern

International, Inc.

CONTENT WILL INCLUDE:• History of providing data and related assets to the FDA• FDASIA, PDUFA V and the recently finalized binding guidance

documents covering electronic submissions and standardized study data

• Submission Data Packages – what to include, how to create them, things to consider

• SDTM domain datasets & ADaM analysis datasets• Data definition files (define.xml & define.pdf)• Annotated CRFs• Study Data Reviewer’s Guides, Analysis Data Reviewer’s Guides, and

Study Data Standardization Plans

GAIN IN-DEPTH KNOWLEDGE WITH THE PRE-CONFERENCE WORKSHOPS

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8SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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• How to effectively design, execute and archive your clinical trial assets in order to successfully generate submission data packages and related deliverables

• Review of live examples of source/ legacy and standardized submission data packages

LEARNING OBJECTIVES:• Understand the foundations for the FDA acceptance of clinical data

and related assets and how the expectations for process and format of these deliverables have recently changed

• Be aware of agency expectations for the use of data standards at the time a study is planned/ designed, including the use of CDASH standards for data collection

• Be capable of executing a clinical trial with a focus on both immediate study execution needs and preserving all assets for use at the point in time final submission deliverables are generated

• Be able to recognize the various assets, including both items generated in a Data Management/ EDC setting and those produced by other capabilities

NOTE: The focus of the seminar is FDA data requirements as FDA is currently the only agency that mandates the submission of actual clinical data. Other agencies will soon do the same (Japan, Canada, Europe) and they will be briefly discussed during the workshop, but the main focus is on the US FDA.

Continuing Education Credit: SCDM is authorized by IACET to offer 0.4 CEUs for this program.

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Page 10: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica

10SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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LEADERSHIP FORUM (upon invitation only)Wednesday, September 27 | 08:30 AM – 03:00 PM

Location: Genoa II

FACILITATORS:• Anthony Costello, Vice President, Mobile Health, Medidata Solutions• Demetris Zambas, VP and Global Head of Data Monitoring and

Management, Pfizer, Inc.

SPEAKERS:

BYOD CONSIDERATIONS AND LESSONS LEARNED IN AN ONGOING CLINICAL TRIALA presentation by Pfizer discussing technology implementation efforts and associated challenges with the incorporation of BYOD practices into an ongoing clinical trial.• Timothy R. Joy, Sr Director, Clinical Trial Solutions, Information

Management COE, Pfizer, Inc.• Richard Close, Global Product Development, Lead, Clinical Trial

Solutions IM, Pfizer, Inc.

EMR AND DATA ACQUISITION - OUR JOURNEY, ASPIRATIONS AND PROGRESS...Novartis has leveraged the Digital space and enabled technologies to collect & transfer Data from hospitals, research centers, central labs and specialty centers. The presentation will focus on our current experiences in the EMR and Data acquisition space, share our aspirations and proposals partnering with industry peers, research/ academic centers, EMR vendors, HL7, SCDM and regulatory agencies (the US FDA as a beginning).• Rakesh Maniar, Global Head, Business Technology Services, Global

Drug Development/GDO/PTO, Novartis

SESSION DESCRIPTION:Industry activity around patient engagement and innovations in clinical trials has dramatically increased over the last couple of years. The SCDM Leadership Forum in 2017 will be a unique demonstration of some of the most innovative approaches available and the implementation case studies that have justified their use. This is an important opportunity for senior executives to see and hear about innovative patient engagement technologies that are beyond the hype and being used in production around the industry.

Speakers will bring examples of innovations their teams have implemented in research, lessons learned, playbook advice, regulatory insights and patient satisfaction feedback so that attendees may leave with a much better understanding of:

• ROI justification for the innovation• Company adoption hurdles• International regulatory concerns• Clinical Data Management impacts

This year, we are building the Leadership Forum into the heart of the SCDM Annual Conference so that attendees can easily attend both without dedicating additional days or weekend travel.

Selected invitees can attend this forum. If you are interested in participating, contact us at [email protected].

ENGAGE WITH THE CLINICAL DATA MANAGEMENT INDUSTRY LEADERS & REGULATORS

CO-SPONSORED BY

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Page 12: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica

12SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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ENGAGE WITH THE CLINICAL DATA MANAGEMENT INDUSTRY LEADERS & REGULATORS

Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation (formerly known Division of Scientific Investigations (DSI)) at Center for Drug Evaluation and Research (CDER) in FDA.

Dr. Ayalew oversees verification of the integrity of efficacy and safety data submitted to the FDA in support of new drug and biologic applications and the protection and assurance of the rights and welfare of human research subjects.

Dr. Ayalew obtained his M.D. in 1989 from Haile Selassie University Medical Faculty in Addis Ababa, Ethiopia. Following graduation, he worked as an assistant professor in the Department of Pediatrics at the Gondar University of Medical Sciences in Ethiopia. After being awarded a scholarship, he completed post-graduate training in pediatrics and child health at Leipzig University in Germany. Following successful completion of his post-graduate residency training at Leipzig University, he also completed pediatrics residency at the Long Island College of Medicine followed by a fellowship program at Children’s National Medical Center/ George Washington University in 2000. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is double board certified in Pediatrics and Infectious Disease by American Board of Pediatrics.

Dr. Ayalew serves as a pediatrician at Inova Fair Oaks Hospital in Virginia where he actively continues to provide clinical services in pediatrics and pediatric infectious diseases. He has given numerous didactic lectures and case presentations. He has published publications in peer review journals and holds several awards and credentials from FDA. He has over 27 years of clinical experience, and more than 17 years of regulatory medicine and work experience in FDA.

Kassa Ayalew

Monday, September 25 | 08:45 AM – 10:00 AM

Location: The Ritz-Carlton Ballroom III & IV

KEYNOTE PRESENTATION FDA PERSPECTIVE ON INTERNATIONAL CLINICAL TRIALS

Page 13: DESTINATION ORLANDO · re-invent) from the industry to suit your organization. Come learn what you can do to help your organization manage risk and be Data Driven. Chiltern, BioClinica
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14SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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ENGAGE WITH THE CLINICAL DATA MANAGEMENT INDUSTRY LEADERS & REGULATORS

REGULATORY PANELMonday, September 25 | 03:45 PM – 05:30 PM

Location: The Ritz-Carlton Ballroom III & IV

Celebrating its tenth anniversary, the annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from both the FDA and PMDA on current key topics concerning Clinical Development and the Data Management discipline. In addition to specific updates the panelists will provide, participants will be offered to the opportunity to ask their questions during the Q&A portion of the session.

Do not miss the chance to determine what is critical to our regulators, to your peers, to you and your organization.

SESSION MODERATOR: • Jonathan Andrus, BA, MS, CQA, CCDM, COO and Data Officer,

Clinical Ink, Inc.

PANELISTS:• Dr. Hanako Morikawa, Ph.D., Inspector of the Office of Non-Clinical

and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA)

• Dr. Sean Kassim, Ph.D., Director, Office of Study Integrity and Surveillance, OTS, CDER

• Dr. Leonard Sacks, M.D, FDA/ CDER/ OMP• Dr. Yuki Ando, Ph.D., Senior Scientist for Biostatistics, Pharmaceuticals

and Medical Devices Agency (PMDA)• Dr. Steve Wilson, Ph.D., Director, FDA/ CDER/ OTS/ OB/ DBIII

“This SCDM conference [2015] was my first for Data Management. I couldn’t have been more impressed and the speakers were interesting and knowledgeable in their respective fields. The learning opportunity was incredible! I took well over 20 pages of notes and was able to prepare a presentation to our corporate leadership that helped define both our short-term and long-term strategies. I can’t wait until next year and we are planning on setting up a booth to demonstrate our new services as well. THANK YOU SCDM for all of your hard work and dedication to this evolving industry.”

Jim Carter, Data Specialist, Lab Connect LLC

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15SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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LEARN DURING THE COMPELLING EDUCATIONAL SESSIONS

• Answering the Age Old Question, “Are We There Yet?”

• Clean Data Faster: Leveraging EDC/CTM’s in Global Studies – The Bar is Raising Swiftly

• SDV – What Is It Good For? Absolutely Nothing!

• SDTM and CDASH: Why You Need Both

• Dramatic Change in China Clinical Data Management

• ePRO: Going from Good to Great

• Good Clinical Data Management Practices (GCDMP©) Revision: Status & New Chapter Highlights

• Emerging Trends in Clinical Data Capture and Clinical Research Technologies

• Fail-Safe Central Data Monitoring in RBM – How Do We Achieve It?

• IND Reports Preparation and Submission

• Improving Efficiency and Effectiveness in Data Management of Oncology Studies

• Optimal Use of Today’s Data Management Tools When Monitoring a Clinical Site

• US and Europe Data Management after the Offshoring Efforts

• A Dialog on Integrating eSource into Clinical Research

• Medical Data Review

• eSource and the World of Opportunities

• CDASH V2.0 – What’s New and How Does It Impact Me?

• Becoming a Certified Clinical Data Manager – Preparing for the CCDM™ Exam

• Can You See It? Handling Imaging Data and New Imaging Criterias

• Unstructured and Structured Big Data Convergence for Bridging Clinical, Regulatory, and Commercialization

• Management of Electronic Drug Adherence Data, Monitoring Devices, as well as Real Time Data Monitoring

• Professional Development and Graduate Degree Programs for CDM

• Artificial Intelligence and Clinical Development

• Study Medication Compliance Data Collection Challenges

We are delighted to bring you another set of stimulating educational topics in the field of Clinical Data Management!Pick and choose the sessions that suit best your educational needs.

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16SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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NEXTGEN TECHNOLOGY INNOVATION AWARD (TIA)

Tuesday, September 26 | 01:30 PM – 03:00 PM

Location: The Ritz-Carlton Ballroom III & IV

SCDM strives to improve with the industry. This is why SCDM believes that the best advancements and recent innovations in clinical data management that have improved technology or processes within clinical research studies deserve recognition.

The NextGen Technology Innovation Award contest - previously known as the Data Driven Innovation Awards, seeks to identify innovation which leverages the use of novel technologies or processes and provide relevant paradigms for how it could be used in clinical trials.

MODERATOR:• Charlene Dark, Strategic Account Director – Customer Solutions

Management Group, QuintilesIMS

JUDGES:• Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and

Company• Carol Schaffer, Manager, Early Phase CDM, Roche Innovation Center• Manny Vazquez, Manager Clinical Data Management, PRA Health

Sciences

The audience will also have the chance to cast their vote and act as the 4th Judge.

POSTER PRESENTATIONS

Monday, September 25 | 03:00 PM – 03:45 PM Tuesday, September 26 | 10:00 AM – 10:45 AM

Location: Palazzo Foyer

A jury of experts will select the winners of the three best posters, which will be awarded as follows:

• 1st prize - $300

• 2nd prize - $200

• 3rd price - $100

SESSION LEADERS:• Alexander Bragat, PMP, Director, Clinical Research DataCore, NYU

Langone Medical Center• Susan Howard, Director, Data Management, Adaptimmune, LLC• Richard F. Ittenbach, PhD, Professor of Pediatrics, Cincinnati

Children’s Hospital Medical Center

SCDM would like to thank Waife & Associates, Inc., a process-optimization consultancy devoted entirely to clinical research, for sponsoring the Poster Presentation Awards.

Visit the SCDM 2017 Annual Conference website for the poster presentations list

SPONSORED BY

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Clinical Development • Medical & Scientific Aairs • Data & AnalysisPharmacovigilance • Strategic Regulatory

At Chiltern you are key, because you are at the center of what we do. As you strive every day to bring better, more personalized products to market for your patients, we strive to provide you a better, more personalized experience than any other CRO.

U.S. +1 910 338 4760

Europe +44 0 1753 512 000

Chiltern.com

Connectwith

Chiltern

We’re building clinical development solutions around you — your program, your investigators, your patients.

Meet Chiltern at SCDMin Booth 311

Looking for an experienced and collaborative research partner?Chiltern is Designed Around You®.

Chiltern. A Collaborative Approach Designed Around You®.

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18SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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SPONSORS

KNOWLEDGE PARTNER

DIAMOND SPONSORS

PLATINUM SPONSORS

GOLD SPONSORS

SILVER SPONSORS

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EXHIBITION OPENING HOURS:

Sunday, September 24, 2017 06:00 PM – 08:00 PMMonday, September 25, 2017 10:00 AM – 06:00 PMTuesday, September 26, 2017 10:00 AM – 03:30 PM

Location: Palazzo Ballroom

VISIT OUR DEDICATED VENDORS

BOOTH NUMBER COMPANY

210 ACES Health

504 Adaptive Clinical Systems

303 Advanced Clinical

505 Almac Group

203 Alpha Clinical Systems

209 Apex Life Sciences

101 Axiom Real-Time Metrics, Inc.

611 BioClinica, Inc.

211 BioTrial

213 ByteGrid

111 CDISC

311 Chiltern

601 ClinCapture

500 Clinical Ink

201 Clinical Solutions Group, Inc.

202 Clinovo

608 Comprehend Systems

501 CRF Health

113 CROS NT

205 CRScube America Inc.

604 Cytel, Inc.

309 Dacima Software, Inc

511DCRI - Duke Clinical Research Institute

308 DDi

609 DF/Net Research, Inc.

403 DSG, Inc.

304 DZS Clinical Services and Software/Clinplus

710 eClinical Solutions

711 Edetek

302 ENNOV

BOOTH NUMBER COMPANY

503 GCE Solutions

605 Green Key Resources

502 IBM Watson Health

713 IDDI SA

204 INC Research

212 Integrated Clinical Systems, Inc.

509 Integrated Resources, Inc.

602 LDMS - Laboratory Data Management System

405 MaxisIT, Inc.

712 Medidata Solutions

402 MedNet Solutions

409 Medrio

401 OmniComm Systems

301 OpenClinica, LLC

310 Oracle

703 Orbis Data Solutions

600 PAREXEL

704 PHASTAR

305 Pinnacle 21

612 PRA Health Sciences

105 Protocol First

109 Premier Research

404 Quartesian LLC

300 QuintilesIMS

110 SCDM

400 Statistics & Data Corporation (SDC)

208 Tech Observer

610 Uppsala Monitoring Centre

408 Veeva Systems Inc.

708 Viedoc

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20SCDM 2017 ANNUAL CONFERENCE | SCDM2017.ORG | @SCDM_DATADRIVEN #SCDM17 |

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PRODUCT SHOWCASES

Tuesday, September 26 | 10:00 AM - 10:45 AM

LOCATION: PRODUCT SHOWCASE ROOM 1, PALAZZO BALLROOM

Tuesday, September 26 | 10:00 AM - 10:45 AM

LOCATION: PRODUCT SHOWCASE ROOM 2, PALAZZO BALLROOM

Monday, September 25 | 03:00 PM - 03:45 PM

LOCATION: PRODUCT SHOWCASE ROOM 1, PALAZZO BALLROOM

Monday, September 25 | 03:00 PM - 03:45 PM

LOCATION: PRODUCT SHOWCASE ROOM 2, PALAZZO BALLROOM

Monday, September 25 | 10:00 AM - 10:45 AM

LOCATION: PRODUCT SHOWCASE ROOM 1, PALAZZO BALLROOM

Monday, September 25 | 10:00 AM - 10:45 AM

LOCATION: PRODUCT SHOWCASE ROOM 2, PALAZZO BALLROOM

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GREEN MEETING INITIATIVESEXHIBIT HALL BINGO CARD

SCDM 2017 Annual Conference participants receive a Bingo Card in their conference tote bags and are invited to visit all participating exhibitors listed on the card. Each participating exhibitor will stamp or initial their listing to confirm that the participant visited their booth to learn about the products and services they offer. When all of the listings have been marked, the participant will drop their Bingo Card off at the SCDM onsite registration desk to enter in a draw to win a variety of conference perks!

The draw takes place in the Exhibit Hall (Palazzo Ballroom) on Tuesday, September 26, from 03:00 PM – 03:30 PM.

SCDM is committed to doing its part to preserve the Earth. This year, the SCDM 2017 Annual Conference will take the following steps to reduce the environmental impact:

• Provide recycling bins throughout the Exhibit Hall to reduce waste

• Produce a digital preliminary program and call for abstracts to reduce unnecessary printing

• Centralize the social events within the venue to reduce additional travel

Here’s what you can do to help:

• Recycle your conference program and printed materials

• Carpool

• Recycle your badge and return it to the registration desk before leaving

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WELCOME TO ORLANDO!

TRAVEL & ACCOMMODATION

ABOUT OUR HOST CITY

Orlando is a major city in the US state of Florida. Located in Central Florida, it is the center of the Orlando metropolitan area, the 24th-largest metropolitan area in the country.

The City of Orlando is nicknamed “The City Beautiful” and its symbol is the fountain at Lake Eola. Orlando is also known as “The Theme Park Capital of the World”. It is known for its warm climate, world famous theme parks, shopping malls, golf courses and night life as well as for some of America’s finest beaches. Orlando’s medical leadership has advanced with the completion of the University of Central Florida’s College of Medicine.

LOCAL ATTRACTIONS

• Walk Disney World

• The Mennello Museum of American Art

• Harry P. Leu Gardens

• The Florida Mall

• Bay Hill Club & Lodge (for golf enthusiasts)

• Santiago’s Bodega

AIRPORT

Orlando International Airport (MCO) 1 Jeff Fuqua Blvd Orlando, Florida 32827, USA

ACCOMMODATION

SCDM has negotiated this year again special reduced room rates for your stay in Orlando at Grande Lakes, Orlando Resort Hotel JW Marriott & The Ritz-Carlton.

Reservations at the special reduced room rate of $219++, plus taxes and fees are accepted until Friday, September 1, 2017.

The conference hotels are fully booked for the period September 25-27 hence SCDM is happy to recommend the following hotels. Please note that no preferential rates are available for the group.

Courtyard Orlando Lake Buena Vista in the Marriott Village8623 Vineland AvenueOrlando, Florida32821, USA Tel: +1-407-938-9001

Delta Hotels Orlando Lake Buena Vista 12490 South Apopka Vineland RoadOrlando, Florida32836, USATel: +1-407-387-9999

Book Your Accommodation

Visit the SCDM 2017 Annual Conference website to learn more!

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STRATEGIC CORPORATE PARTNER PROGRAM

ABOUT The Strategic Corporate Partnership program is a multi-platform engagement opportunity that provides leading companies with significant, consistent and exclusive year-round visibility across SCDM’s global community of clinical data managers and key opinion leaders in the DM industry. The customizable agreement is designed to meet mutually beneficial and strategic business goals. Benefits include:

• Access to a qualified market for a company’s products and services

• The ability to interact and engage SCDM leadership and core supporters

• An opportunity for employees of the corporate partner to become active participants and advocates for the SCDM mission

MEMBERSHIP DEMOGRAPHICSSCDM membership has grown at an average rate of 15% per year since 2003, and stands currently at more than 2300. It represents mainly members in the United States (60%), India (20%), Canada (4%), Japan (1%) and China (4%).

The Society draws members from a variety of industries.

28% Contract Research Organization

25% Pharmaceutical

16,5% Biotechnology

10% Medical Device/Diagnostic/Imaging

6,5% Imaging

5% Academic Health Center

3,5% Consulting Firm

2,5% Hospital

2% Vendor

0,5% Recruiter

0,3% Centralized Laboratory

0,2% Site Management/Regulatory Agency

28% Contract Research Organization

25% Pharmaceutical

16,5% Biotechnology

10% Medical Device/Diagnostic/Imaging

6,5% Imaging

5% Academic Health Center

3,5% Consulting Firm

2,5% Hospital

2% Vendor

0,5% Recruiter

0,3% Centralized Laboratory

0,2% Site Management/Regulatory Agency

WE WOULD LIKE TO THANK OUR 2017 CORPORATE PARTNERS

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THANK YOU! The Society for Clinical Data Management would like to thank all of its members, volunteers, and sponsors who have supported us throughout the years.

We appreciate the joint commitment and contribution to deliver valuable education and innovative programs to the SCDM 2017 Annual Conference.

Mark your calendar and make sure you join us next year in Seattle-Bellevue as we embark on the next Clinical Data Management advances!

ANNUAL CONFERENCE

SEPTEMBER 23–26 I SEATTLE – BEL LEVUE

SCDM 2018

SeattleBellevue

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