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Page 1: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

DESTINATION BALTIMORE

Page 2: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

AC AT-A-GLANCE ................................................................................... 3

CONFERENCE HIGHLIGHTS ............................................................... 5

NETWORKING OPPORTUNITIES ....................................................... 8

PRE-CONFERENCE WORKSHOPS .................................................... 9

LEADERSHIP FORUM ......................................................................... 11

KEYNOTE SPEAKER ........................................................................... 15

HIGH-LEVEL PANEL DISCUSSIONS ................................................ 16

SCDM MOBILE APP ............................................................................ 16

EDUCATIONAL SESSIONS ................................................................. 18

MEET OUR SPONSORS ...................................................................... 21

POSTER PRESENTATIONS ................................................................ 20

MEET OUR EXHIBITORS .................................................................... 22

PRODUCT SHOWCASES .................................................................... 25

WELCOME TO BALTIMORE ............................................................... 29

TRAVEL & VENUE ................................................................................ 31

STRATEGIC PARTNER PROGRAM ................................................... 33

TABLE OF CONTENTS

Page 3: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

AT-A-GLANCE25 YEARS OF SCDM

150+ speakers

300+ organizations

70+ functions

800+participants

2019: SCDM 25th Anniversary

2012: 703 Attendees in L.A

2000: GCDMP©Publication

2009: SCDM 15th Anniversary

Innovations & eSouces

CCDM®

AI

1998: GCDMP©Committee

1994: founding of SCDM

Data Connections

1997: first SCDM Annual Conference

GCDMP©

THANK YOUThe Society for Clinical Data Management would like to thank all its members, volunteers, and sponsors who have supported us throughout the years. We appreciate the joint commitment and contribution to deliver valuable education, innovate programs and build our community.

Page 4: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development
Page 5: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

SCDM LOOKS FORWARD TO WELCOMING YOU TO BALTIMOREThe SCDM 2019 Annual Conference is just around thecorner. SCDM invites you to participate in the world’s largestinternational educational event for Clinical Data Managersand related professionals. This year, the SCDM 2019 AnnualConference will take place at Baltimore MarriottWaterfront, on September 29 - October 2. The conferencevenue will host all educational sessions, exhibition andsocial events to ensure that you make the most of yourSCDM experience. We look forward to welcoming you very soon!

Baltimore Marriott Waterfront700 Aliceanna StreetBaltimore, Maryland 21202 USA

CONFERENCE HIGHLIGHTS • Discover more about the Educational Sessions in the SCDM 2019 Annual Conference program, led by our 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 a Regulatory Submission Pre-Conference Workshop.• Visit the Exhibit Hall and meet our Sponsors and Exhibitors to experience new products and innovative industry technology.• View SCDM’s Poster Presentations on Monday, September 30.• Get involved in one of the many networking opportunities available during the conference, such as the Opening Reception and the Networking Reception.

• Find out more about SCDM activities during the SCDM session of interest and the SCDM Volunteer Happy Hour.• Having difficulties choosing from the multitude of compellingeducational sessions? This year you will have the opportunity to vote for the session you have missed to be duplicated in the Pop-Up Sessions time slots.• Seize the opportunity to win exciting prizes with the Social Media and the Best Promotional Giveaway contests, SCDM’s innovative and fun ways to learn about its activities and the CDM industry.• Promote a healthy lifestyle by attending the SCDM Run/ Walk.

REGISTER NOW!

Page 6: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

FIRST DIGITAL TRIAL PLATFORM AT GLOBAL SCALETelemedicine | eCOA | ePRO | eConsent

M E D A B L E . C O M

©2019 MEDABLE INC. | ALL RIGHTS RESERVED

Medable is the only global digital-trials platform with integrated patient, site, and device support.

Medable SCDM Full Page Ad 071019 04 Final.indd 1 7/22/19 2:14 PM

Page 7: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

From evidence.

To engagement.

To an entire ecosystem.

We believe “what ’s possible” can always go

further. That ’s why we do things differently

at IQVIA – by bringing the science of

healthcare together with data science,

advanced analytics and expert knowledge.

It ’s how we look beyond what ’s expected in

healthcare to see what ’s possible.

Others may offer a way forward. IQVIA gives

you a way further.

> > > > > > > > > > > > > > >

> > > > > > >

> > > > > > >

Y O U RW A YF U R T H E R

IQVIA.COM/FURTHER

Visit us in booth 102 during SCDM.

SocietyClinicalDataMgmt Evidence A4.indd 1 7/16/2019 2:12:13 PM

Page 8: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

OPENING RECEPTIONSunday, September 29 | 06:00 PM - 08:00 PMLocation: Exhibit Hall

Let’s kick-off the 25th Annual Conference in the right way. The Annual Conference welcomes all attendees to the Opening Reception. Meet the top industry leaders and sponsors during this exceptional networking opportunity, while enjoying a bubbling drink and some nibbles.

The reception will start at 06:00 PM. Be there on time! We don’t want you to miss the ribbon cutting ceremony.

SPONSORED BY:

25th ANNIVERSARY NETWORKING RECEPTION LIGHTS. CAMERA. ACTION.Tuesday, October 1 | 07:30 PM – 09:30 PMLocation: Bar Vasquez

Let’s go back to the past, to an epoch where everything was possible. Lively and happy streets, fancy and exclusive parties, jazz, economic prosperity, craziness, prohibitionist, rebellion and freedom. This year’s theme is designed to connect the past and the future – of our community, our industry and our careers. Let’s celebrate this milestone year with the same spirit as in the ‘Roaring 20s’!

Dress Code: Silver Themed AttireTicket Price: $100

SPONSORED BY:

SOCIAL ACTIVITYSCDM RUN/ WALKMonday, September 30 | 07:00 AM - 07:45 AM

“A run a day keeps the doctor away”. For our 25th Anniversary, we want to keep our community young and fresh, let’s make this happen! Join us for a revitalizing run / walk before a productive and amazing first day at the SCDM Annual Conference. Registration is free, but SCDM encourages participants to make a modest donation to CISCRP to help increase clinical research literacy among patients and their families. SCDM challenges conference attendees and community members to help in reaching a $5,000 donation goal. For this purpose, please select ‘SCDM 2019 Run/Walk’ under ‘Apply My Donation To’ in the below link.

SPONSORED BY:

NETWORKING OPPORTUNITIES

Pre-registration is mandatory and spaces are limited and offered on a first-come, first-served basis. Book your ticket now!

DONATE

Page 9: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development
Page 10: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

A DESIGN THINKING APPROACH TO EXPLORING AUTOMATION TECHNOLOGIES IN CLINICAL DEVELOPMENT OPERATIONS Sunday, September 29 | 08:00 AM - 12:00 PMLocation: Laurel AB

LEADERIan Shafer, Partner, PwC Pharmaceutical Advisory Practice

In this first part of this session PwC will provide educational introduction to several automation technologies, including robotics process automation (RPA), machine learning (ML), and artificial intelligence (AI). We will describe the individual characteristics of each technology, including strengths and limitations, as well as practical uses of these technologies. In the second part of the session, PwC will lead a series of activities, using design-thinking techniques to identify pre-competitive opportunities in the clinical development process where automation technologies can have the most impact, followed by a team effort to co-create and refine selected automation use-cases. At the end of the session, a contest will be held where all participants will vote for the top three use cases.

LEARNING OBJECTIVES

• Learn fundamentals of advanced analytics, robotics process automation, machine learning, and artificial intelligence • Learn about characteristics of each technology, appropriate use cases and best practices • Identify practical and pragmatic uses cases for the applications of automation technologies within clinical development• Leverage design-thinking approaches in team settings to elicit and co-create use cases

PREPARING DATA FOR A REGULATORY SUBMISSIONSunday, September 29 | 01:00 PM - 05:00 PMLocation: Laurel AB

LEADERFrederick Wood Jr., Ph.D, Vice President, Data Standards Consulting Group

Requirements exist for the submission of standardized electronic study data to the FDA. This workshop will summarize the regulatory basis for submitting such data, provide an overview of the standards that govern such submissions, and discuss the additional support files necessary for a complete submission.

LEARNING OBJECTIVES• Understand the regulatory basis for the requirements for electronic data and standardized electronic study data • Become aware of the specific data standards the agency expects • Recognize that additional documents/files are required to support the submission of study data

GAIN IN-DEPTH KNOWLEDGE WITH THE PRE-CONFERENCE SESSIONS

Continuing Education Credit: SCDM is authorized by IACET to offer 0.4 CEUs for these programs.

Page 11: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Better Decisions

Shorter Timelines

Unmatched Service

Unified Technology

Unified eClinical Solution.

®

Accelerate your clinical program with Axiom.Intuitive, powerful and cost-effective

Unified eClinical solutions and managed services.

www.axiommetrics.com | [email protected] | phone 1.877.321.9191

Data BasicsEDC/DM

Pre-Screening LogData Coding General Log

ePRO/eCOA ePRO/eDiary App

ePRO/eDiary Web AccessePRO/eDiary Phone Access

Safety AE/SAE Tracking

Safety Management

Choose the Fusion Modules to Power Your Studies

IWRS/RTSMIWRS/IVRS

CTM Tracking

CTMSCTMS Dashboards

Deviations Management Study Start-Up

Payment TrackingTrip Reporting

eTMF

Data Import / Adjudication Central/Local Lab Import

AdjudicationData Import

SAS On-Demand

Clinical OperationsProject ManagementData ManagementData AnalyticsPharmacovigilanceBiostatsMa

nage

d Ser

vices

Page 12: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Sunday, September 29 | 09:00 AM – 04:00 PMLocation: Laurel CD

In September, our global Leadership series continues in Baltimore.Over the course of the forum, we will go on a highly interactive journey in three parts. The focus areas of the CDM industry’s most popular leaders event are as follows: • Challenges Clinical Data Management leaders face today • Rapidly evolving technologies to address these challenges • Re-imagining the discipline of Clinical Data Management for the futureStarting with a roundtable discussion, we will consider our industry’s top challenges in data management and how we can tackle these to progress from present to future. The forum will also include panel discussions on the current and upcoming regulations and their impact on our work. In order to understand the interface between regulation and technology, we will receive key updates from the SCDM Innovation Committee.

PANELISTSKassa Ayalew, Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDALisbeth Bregnhøj, MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP, Danish Health and Medicines AuthorityNi Aye Khin, Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDAJean Mulinde, Medical Officer, Senior Policy Advisor Division of Clinical Compliance Evaluation Office of Scientific Investigations, CDER, FDAPatrick Nadolny, Associate VP, Clinical Data Management and Programming, Allergan

LEADERSHIP FORUMIDENTIFYING AND ENGAGING

THE NEXT GENERATION OF CLINICAL DATA MANAGEMENT

APPLY NOW!

Page 13: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

MEG RICHIEVice President, Global FSP Operations – Clinipace

Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development (12 years). She has directed teams of over 700+ global multi-functional

employees and over 90+ FSPs. Meg has received recognition awards from past companies in Talent Management and Outstanding Executive for FSP Operational Excellence. She presented at the SCDM conference in 2010 and was a panel speaker last year.

DEREK PERRIN Executive Director, Data Management – Astellas Pharma

Derek Perrin has over 25 years of experience in the field of pharmaceutical research. He has spent the majority of his career focused on Clinical Data

Management. Derek has been leading the Data Management team at Astellas since 2012. Prior to joining Astellas, Derek worked for both Pfizer and Eli Lilly & Company in data management roles of increasing responsibility and support for multiple Therapeutic Areas of clinical research.An active supporter of the Society for Clinical Data Management, Derek first joined the SCDM Board of Trustees in 2005 for a three year term. He returned to board service in 2012 as a Trustee. He participated on the SCDM Executive Committee, and led the organization as Chair for SCDM’s board in 2015.Derek holds of Bachelor of Science degree in Organizational Leadership from Purdue University, and he is proud to be a Certified Clinical Data Manager.

MEET THE LEADERSHIP FORUM FACILITATORS

Page 14: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

DISCOVER DATA CERTAINTY FROM SOURCE TO SUBMISSIONWith a Fit-For-Purpose eSource Solution

Get anytime, anywhere access to your trial data and reach database lock sooner with Clinical Ink’s eSource ecosystem. Its fit-for-purpose eCOA and ePRO modules

capture and validate data from sites, clinicians, and patients at the source. Not only do the modules work with your existing systems, they’re also easy to implement!

Free henna tattoos in Booth 103.

Scheduled PresentationLearn more about cutting-edge solutions and best practices in the clinical data management industry:

Regulatory PanelTuesday, October 1 | 8–9:30 a.m.

Jonathan AndrusChief Business Officer

Page 15: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Monday, September 30 | 09:30 AM - 10:30 AMLocation: Grand Ballroom V-VI

KENT THOELKEChief Scientific Officer and Executive Vice PresidentPRA Health Sciences

Kent Thoelke is the Chief Scientific Officer and Executive Vice President of PRA Health Sciences. With over 28 years in the drug development and

clinical trials industry, Mr. Thoelke has had the opportunity to participate in all levels of drug research from the bench to the bedside globally. Having had the opportunity to work in biotech, pharma and the CRO industries, he brings a unique perspective based on those experiences to the modernization of clinical trials. In addition to his current roles in the oversight of Scientific Affairs, Medical Affairs and Patient Safety, he has spent the last decade focused on the use of Real World Data and Technology to support novel mechanisms to make clinical trial access and drug development more efficient. Through the creation of departments focused solely on Real World Data, Real World Evidence, advanced analytics via machine learning and artificial intelligence, and technology applications to support mobile and virtual trials he has been an industry pioneer, leader and vocal champion for disrupting the current paradigms to ensure that every patient has access to the best possible care options.

RE-DEFINING, RE-IMAGINING AND RE-ENGINEERING THE DRUG DEVELOPMENT PARADIGM THROUGH THE LENS OF REAL WORLD DATA, PATIENT LEVEL DATA, MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE

The discussion will focus on the premise that the current drug development and clinical trial paradigm is highly inefficient and has resulted in time to market timelines of up to 10 years and associated costs of almost $2Bn dollars. This model is both unsustainable and unacceptable as it keeps critically needed medications out of the hands of patients and costs patient lives. The explosion of real world data that is being created and made available, and the analytics via Machine Learning and AI have given us the opportunity to create Real World Evidence in ways unimaginable even a few year ago. These capabilities have the potential to disrupt the entire drug development paradigm for the better. This new data driven paradigm will provide greater and quicker access to clinical trials for patients by lowering the barriers to entry. Simultaneously the ability to leverage RWD/RWE to create synthetic control arms and data for trials will ensure the most efficient use of patients in the drug development ecosystem.

KEYNOTE SPEAKER

Page 16: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

REGULATORY PANEL Tuesday, October 1 | 08:00 AM - 09:30 AMLocation: Grand Ballroom V-VI

The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA and EMA 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.

Panelists will be answering your questions to determine the most critical industry challenges and to provide the relevant guidance you require. Please submit your questions by September 2.

MODERATOR Jonathan Andrus, M.S., CQA, CCDM, Chief Business Officer Clinical Ink, Inc.

PANELISTSKassa Ayalew, Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER FDALisbeth Bregnhøj, MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP Danish Health and Medicines AuthorityNi Aye Khin, Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER FDAJean Mulinde, Medical Officer, Senior Policy Advisor Division of Clinical Compliance Evaluation Office of Scientific Investigations, CDER FDA

HIGH-LEVEL PANEL DISCUSSIONS

SUBMIT YOUR QUESTION

PANEL OF EXPERTS Wednesday, October 2 | 08:30 AM - 10:00 AM Location: Grand Ballroom V-VI

As an Anchor Plenary session to the overall Annual Conference, we are assembling a “Panel of Experts” representing the different towers within our industry to reflect on key challenges and opportunities relevant to our discipline. We aim to identify common as well as unique challenges we are facing across the respective areas of expertise of the panelists as well as potential paths forward either based on the panelists’ experiences or key information presented during the annual conference. In essence we will be conducting an interactive SWOT analysis among the panel inclusive of questions and challenges posed to the panel by the audience.

MODERATOR Demetris Zambas, VP and Global Head of Data Monitoring and Management, Pfizer

PANELISTS Jonathan Andrus, M.S., CQA, CCDM, Chief Business Officer, Clinical Ink, Inc.Lisbeth Bregnhøj, MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP, Danish Health and Medicines AuthorityJennifer Duff, Managing Director, Accenture Life SciencesNi Aye Khin, Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDAPatrick Nadolny, Associate VP, Clinical Data Management and Programming, AllerganFrancois Torche, CEO, CluePoints

Page 17: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

D O W N LO A D T H E A P P

STAY CONNECTED WITH THE SCDM MOBILE APP We are proud to present our 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/ speakersBUILD 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 featuresRATE the sessions’ content and speakers NETWORK with your peers GET LIVE ACCESS to key information that will make your experience memorable

Page 18: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

C

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CM

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CMY

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SCDM_advert_2019.pdf 1 7/11/19 4:44 PM

Page 19: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Syneos_Beach_SCDMConference_215.9x279.4.indd7-1-2019 12:57 PM Suk Choi / Suk Choi

1

JobClientMedia TypeLiveTrimBleedPubs

NoneNoneNone195.9 mm x 259.4 mm215.9 mm x 279.4 mm225.9 mm x 289.4 mmNone

Job info

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Art DirectorCopywriterAccount MgrStudio ArtistProofreader

NoneNoneNoneNoneNone

Approvals

FontsOpen Sans (Regular), Minion Pro (Regular), Montserrat (Bold, Regular)

ImagesControlStrip.eps (100%), GettyImages-554225861-CMYK.tif (CMYK; 405 ppi; 74.05%), Getty-Images-168166200-extended_4C_Mag.tif (CMYK; 615 ppi, -616 ppi; 48.72%, -48.72%), Syneos Health_PSO_LWC_Imp.ai (27.28%)

Inks Cyan, Magenta, Yellow, Black

Fonts & Images

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syneoshealth.com

INC Research and inVentiv Health have become Syneos Health™, the only fully integrated biopharmaceutical solutions organization with a unique approach. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together with a singular goal — greatly increasing the likelihood of customer success. We call our business model Biopharmaceutical Acceleration. You can call it the future.

SHORTENING THE DISTANCE FROM LAB TO LIFE®.FROM LAB TO LIFEFROM LAB TO LIFE®.

Page 20: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

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 educationalneeds. SEE ALL SESSIONS HERE!

LEARN DURING THE COMPELLING EDUCATIONAL SESSIONS

POP-UP SESSION

Having difficulties choosing from the multitude of compelling educational sessions at SCDM 2019 Annual Conference? This year you will have the opportunity to vote for the sessions you have missed and have them duplicated in the Pop-Up Sessions.

PODCASTS Check out our Podcasts section to find updates directly from the SCDM 2019 Annual Conference Co-Chairs and Session Chairs. Do not miss out on the exciting educational opportunities!

SOCIAL MEDIA CONTESTCalling all SCDM followers! Spread your voice and win amazing prizes with the #SCDM2019 Social Media Contest! At SCDM, we are very proud of our growing online movement. At this year’s Annual Conference, we want to reward you as you keep sharing the best of your conference experience with our digital community.To enter, start by using the hashtag #SCDM2019. Then, like the SCDM social media account on the platform you posted. Three prizes will be given to the participants with the best caption, the best photo and the most likes.

Page 21: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

YOUR WORLD WORTH MORE Innovative data solutions to drive better decisions

www.covance.com/FSPx Covance is the drug, medical device and diagnostics business segment of LabCorp, a leading global life sciences company. COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.

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Please stop by our booth #302 at SCDM 2019 to learn how we can build a tailored solution to meet your needs.

Covance FSPx is proud to be a sponsor and a corporate partner of SCDM.

Page 22: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Two dedicated poster presentation sessions will take place on Monday, September 30 at 03:15 PM – 04:00 PM and 05:30 PM – 06:15 PM during which presenters will be present at their poster board to discuss their poster with the judges and delegates.A jury of experts will select the winners of the three best posters, which will be awarded as follows:1st prize – $3002nd prize – $2003rd prize – $100

POSTER JUDGESAlexander Bragat, Director, Clinical Research DataCore, NYU Langone Medical Centre Susan Howard, Director, Data Management, Adaptimmune LLC Richard F. Ittenbach, Professor of Pediatrics, Cincinnati Children’s Hospital Medical Centre

SCDM would like to equally thank Paidion Research, Inc. for sponsoring the Poster Presentation Awards. Paidion Research, Inc. is a clinical research organization (CRO) focused solely on pediatrics and specializing in NICU and PICU populations (neonatal and pediatric intensive care). Headquartered in Durham, NC, they combine pediatric clinical pharmacology expertise with innovative pediatric regulatory strategies and trial methodologies to provide best-in-class service to drug development partners in industry, government, academia and nonprofits. For more about the company, visit their website www.paidionresearch.com or email [email protected].

Check out the SCDM 2019 Annual Conference website for the poster presentations list.

POSTER PRESENTATIONS

Page 23: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Accelerate study cycle timesGet clean data faster

Reduce clinical trial costs

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Veeva Vault Clinical Data Management Suite offers EDC, data cleaning,

coding, and review in a single uni�ed suite. You can manage study build

through execution and gain a complete and concurrent view of all clinical data

within a trial. Vault CDMS accelerates study timelines by reinventing traditional

data management systems and processes.

Visit us at SCDM booth 303 to learn more.

Veeva_CDMSad_SCDM_19_v1.pdf 1 8/8/19 5:48 PM

Page 24: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

MEET OUR SPONSORS

DIAMOND SPONSORS

KNOWLEDGE PARTNER

SUPPORTING SPONSOR

MEDIA PARTNERS

PLATINUM SPONSORS

SILVER SPONSORS

GOLD SPONSORS

Page 25: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development
Page 26: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

We are looking forward to you exploring the exhibit hall this year. With our largest number of companies, academic institutions and associations to date, it could be the place where you find critical solutions to your research and business challenges. In 2019, you will be voting for your favourite giveaway. Make your voice heard and show your appreciation for the favorite exhibitors!

VISIT OUR DEDICATED VENDORS

COMPANY BOOTHAdvanced Clinical Systems 107

Advanced Clinical 415Alpha Clinical Systems 318

Anju Software / ClinPlus 314Axiom Real Time Metrics 410

Barrington James 601Bioclinica 307BioForum 603

Castor EDC 604CDISC 704 TB*

Clinical Ink 103ClinCapture 204ClinConsent 702 TB*Clinical Pipe 116

Clinical Solutions Group 109CluePoints SA 315

CMed Inc. 105Comprehend Systems 311

Covance 302Cros NT 608

CRScube America, Inc. 413Cytel 113

Dacima Software, Inc. 313Datatrak 212

DF/Net Research, Inc. 112DSG, Inc. 104

DZS Clinical Services 316eClinical Solutions 411

Edetek 108Formedix 106

GCE Solutions 205Genae 217

IBM Watson Health 115Integrated Clinical Systems, Inc. 111

IQVIA 102

COMPANY BOOTHMaxisIT Inc. 207

Medable 607Medidata 306

Mednet Solutions 208Medrio 403Merck 405

MMS Holdings 500Navitas Lifesciences 605OmniComm Systems 402.414

Open Clinica 312Oracle 406

Orbis Data Solutions 606Parexel 203

PharmaSUG 703 TB*Phastar 407

Pinnacle 21 214PPD 504

PRA Health Sciences 417Prelude Dynamics 602Premier Research 110

Quanticate 409Quartesian LLC 502

Remarque 206Saama 211SCDM 701 TB*

Signant Health 202snapIoT 501

Statistics & Data Corporation (SDC) 209Syneos Health 114

TrialStat Solutions Inc. 505uMotif 309

Uppsala Monitoring Centre 404Veeva Systems 303

Viedoc (PCG Solutions AB) 210XClinical Services America 215

*TB: Table Top

Page 27: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

EXHIBIT FLOORPLAN

HARBORSIDE FOYER

HARBORSIDE BALLROOM

116 417

115

113 313

217 315

111 311211

215

109 209 309

404

107 207 307

402

105 205

103 203303

214

212 314

318 414

210410

312

316

208

206 306 406

204

202302

114 415

112 413

110 411

108 409

106 407

104 405

601

602

603

604

605

606

607

608 102 403

KEN

T

505504502501500

704702

701

703

Page 28: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development
Page 29: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

PRODUCT SHOWCASES

Monday, September 30

12:45 PM - 01:30 PM

03:15 PM - 04:00 PM

PRODUCT SHOWCASE 1 LOCATION: LAUREL A

PRODUCT SHOWCASE 1 LOCATION: LAUREL A

PRODUCT SHOWCASE 2 LOCATION: LAUREL B

PRODUCT SHOWCASE 2 LOCATION: LAUREL B

PRODUCT SHOWCASE 3 LOCATION: LAUREL C

PRODUCT SHOWCASE 3 LOCATION: LAUREL C

Tuesday, October 1

09:30 AM - 10:15 AM

12:30 PM - 01:15 PM

PRODUCT SHOWCASE 1 LOCATION: LAUREL A

PRODUCT SHOWCASE 1 LOCATION: LAUREL A

PRODUCT SHOWCASE 2 LOCATION: LAUREL B

PRODUCT SHOWCASE 2 LOCATION: LAUREL B

PRODUCT SHOWCASE 3 LOCATION: LAUREL C

PRODUCT SHOWCASE 3 LOCATION: LAUREL C

PRODUCT SHOWCASE 4 LOCATION: LAUREL D

PRODUCT SHOWCASE 4 LOCATION: LAUREL D

Page 30: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Stop by booth 306 and sign up for the Genius Bar to discover how Medidata’s unified platform allows you to see your data in a new way and ensures quality like never before.

Page 31: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

UPCOMING EVENTSWant to expand your knowledge even further?

Join us at the our regional events!

SCDM EMEA Conference and Leadership Forum October 23-25, 2019 | Berlin, Germany

SCDM China Annual Conference December 7-8, 2019 | Shangai, China

SCDM India Annual Conference December 6-7, 2019 | Karnataka, India

Page 32: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

CASE STUDY

OPTIMIZE YOUR CLINICAL TRIALS. Simplify study builds, streamline data collection and easily adapt to evolving demands with iMednet,an all-in-one eClinical platform.

Native modules provide a comprehensive and completely seamless platform.

Why Mednet? With nearly two decades of experience and more than 1,000 studies with both CROs and life sciences sponsors, Mednet has the knowledge and experience to help you achieve success. Beyond its comprehensive eClinical platform, Mednet’s professional services team has the real-world experience to effectively support your clinical research projects from start to finish.

Visit our booth and learn more at mednetsolutions.com.

Contact us at [email protected] or 866.258.2735.

Page 33: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

A city seeping with history, eccentric neighborhoods and luscious food, it has been named the new tourist hotspot and the recent home of young entrepreneurs of the world.It is the largest city in the state of Maryland and has the second largest seaport in the Mid-Atlantic. This was once the second leading port of entry for immigrants coming from Europe, now known as a historic preservation landmark in the city of Baltimore.Many diverse figures of history come from the city, with the likes of Edgar Allan Poe, Billie Holiday and Spiro Agnew to name a few that proved to lead an everlasting mark. In entertainment, iconic shows such as “The Wire” and “Hairspray” defined Baltimore’s television image.

Join us in Baltimore, a must-visit location for all foodies!

Start your journey with the best crab in the country, accompanied by a delicious wine from one of the many local wineries – or a fresh Natty Boh, Baltimore’s national beer. Still some room for dessert? Try one of the iconic Bergers cookies, hand dipped and impossible to resist.

WELCOME TO BALTIMORE!ABOUT THE ‘COOLEST CITY ON THE EAST COAST’

LOCAL ATTRACTIONS• Inner Harbor• Baltimore Museum of Art• Fort McHenry National Monument and Historic Shrine• Lexington Market• American Visionary Art Museum• National Aquarium• Camden Yards• Walters Art Museum

FUN FACTS ABOUT BALTIMORE• Lexington Market was founded in 1782 and it is the oldest market in the Unites States of America. • Michael Phelps, the most successful Olympian of all time with 22 medals, was born in Baltimore. • Baltimore was the birthplace of the six-pack beer, it was created with the ingenious idea of four beers not being enough and eight being too many. • In 1812, Francis Scott Key wrote the National Anthem while watching the bombardment of Fort McHenry. • Baltimore has more public statues and monuments per capita than any other city in the Unites States.

Page 34: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Isn’t it time you loved your forms?

Never settle. That’s good advice for relationships, and for e-clinical technology. Getting better data, faster, starts with eCRFs that really know how to communicate. Traits to look for? Cross-form alculations, real-time edit checks, and easy skip logic. You can check off all three with OpenClinica. Forms should never forget an anniversary, or an A1C level, either. With auto-save, ours never will. Of course, good looks can’t hurt. A clean, flexible layout on any device helps keep the spark alive—for you, your sites, and your participants.

Intrigued? Stop by booth #312 for a no pressure introduction. If you’re ready for dinner and drinks, visit bit.ly/lovedm and RSVP for our Monday evening reception.

Page 35: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

TRAVEL AND VENUE

TRAVELBWI Marshall AirportBWI7050 Friendship Rd,Baltimore, MD 21240

BWI Marshall Airport is located just 9 miles south of downtown Baltimore and 32 miles northeast of Washington, D.C. It is the busiest airport in the region, serving over 25 million passengers. The airport is named after Thurgood Marshall, a Baltimore native who became the first African American to serve on the Supreme Court of the United States.

BALTIMORE MARRIOTT WATERFRONT700 Aliceanna StreetBaltimore, Maryland 21202 USA

Situated in the lively Harbor East, the Baltimore Marriott Waterfront offers stunning views of both the Inner Harbor and downtown Baltimore. The hotel is close to many attractions of interest, including Inner Harbor, Fells Point, the National Aquarium and M&T Bank Stadium.The hotel’s well-appointed amenities include a heated indoor pool and a 24-hour fitness centre. All this, combined with the well-designed rooms and expansive event venues, will make your stay at the Marriott Waterfront unforgettable.

BOOK YOUR ROOM

Page 36: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

Randomization & Trial Supply Management

Design

Start-up

Conduct

Close-out

Post Marketing

Case Processing

WorkflowCase Intake

Edit Checks

Natural Language Processing

Business Rules

ArtificialIntelligence

SignalValidation

ElectronicGateway

Regulatory ReportingSecurity/Privacy

Coding

ORACLE HEALTH SCIENCES.UNIFYING ACTION,

ACCELERATING RESULTS.

Oracle’s Clinical One platform is a single, unified interface where Data Managers define, validate, and collect data only once to accelerate study timelines and improve the quality of data.

www.oracle.com/healthsciences

Copyright ©2018 Oracle and/or its affiliates. All rights reserved.

Quality & Simplicity by Design

Learn more. Visit us at booth 406

Page 37: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

ABOUTThe 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 DEMOGRAPHICS SCDM membership has grown at an average rate of 15% per year since 2003, and stands currently at more than 2200. It represents mainly members in the United States (60%), India (20%), Canada (4%), Japan (1%) and China (4%).

STRATEGIC CORPORATE PARTNER PROGRAM

WE WOULD LIKE TO THANK OUR 2019 CORPORATE PARTNERS

UNITED STATES 60% INDIA

20%

CHINA 4%

CANADA 4%

JAPAN 1%

Page 38: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

When developing an innovative new therapy, using equally innovative techniques can accelerate your treatment’s journey to the patients who need it.

Come chat to us at booth #203 and attend our talks on Oct. 1st to find out more:

Session 28 Navigating the Dynamics and Challenges of “Clean” Interim Analyses by Cinda Hensdale, Data Management Director.

Session 30 Real World Data to Real World Evidence by Yashpalsinh Raj, Senior Clinical Data Analyst.

©2019 Parexel International Corporation. All rights reserved.

We’re the people who do everything

B1119-24 Parexel SCDM print ad v3 AW.indd 1 26/07/2019 17:07

Page 39: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

EXPLORE. COMMUNICATE. PIONEER.

S E P T E M B E R 1 3 - 1 6S A N A N T O N I O

SCDM 2020A N N U A L C O N F E R E N C E

C E L E B R A T E T H E W O R L D ’ S L A R G E S TC L I N I C A L D A T A M A N A G E M E N T C O N F E R E N C E

Page 40: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development
Page 41: DESTINATION BALTIMORE · Vice President, Global FSP Operations – Clinipace Meg Richie has over 23 years in the CRO industry with a background in data management and FSP development

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SCDM 2019 Destination Baltimore (SDC Booth 209).pdf 1 7/24/2019 1:44:19 PM