© 2017 SCDM 2017. SCDM © 2016 - All rights reserved
Join us to hear the latest developments on the chapters within the GCDMP©. We have established task forces for our chapters targeted in 2017 but we are still hoping for more volunteers for 2018 chapters. Find out what is planned and how you can volunteer your expertise. Great collaboration, networking opportunities, and re-certification credits available through participation.
Target Audience: Audience is open to all levels. Seeking participants who are in roles of managing trials within their organization and preferably certified as we are indirectly assisting the content alignment committee.
This session is a roundtable dedicated to collaborative discussion around study medication compliance data collection. The panelists will explore many aspect of study medication compliance data collection that influences data management – study design, data collection and quality, mechanism of data collection (paper v electronic diaries, smart packaging, and pill counts) inspection by regulatory agencies, etc. The session will be a mix of facilitated discussion with subject matter experts sharing experience and best practices, as well as audience participation and idea sharing.
Session Chair: Megan Olberding, Associate Director, Merck & Company
Cecilia Calcagno, Lead Data Manager, PRA Health Sciences
Alla Muchnik, Sr. Clinical Data Manager, Cytel, Inc.
Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience
CDM Certification Competencies: Electronic Data Collection, Clinical Trials Processes, Roles, and Responsibilities, Data Management Plans, Clinical Database Design/ Relational Data Bases
Target Audience: Study Data Manager, Data Manager, Statistics Programmer
Recent advancements in technology have changed the conversation on artificial intelligence from the theoretical to the practical. There is no longer any doubt that this technology will have vast and profound effects on business, social structure, and of course, human health. This presentation will address the main implications to be considered in clinical development, and in the context of eClinical systems. Artificial Intelligence can be divided into additional subtypes, Machine Learning, which is a subtype of Artificial Intelligence, and Deep Learning, which is a subtype of Machine Learning. Each of these has significant and progressively powerful applications in clinical development.
Session Chair: Scott Weidley, CEO, ClinCapture
Derek Lawrence, Senior Clinical Data Manager, Rho
Chen Chen, Manager, DM Team Lead, Pfizer (China) Research and Development Center
Target Audience: Study Data Manager, Data Management Department Manager, CRA
In the past two decades, the Clinical Data Management profession has evolved significantly through technological advancement, new skills, knowledge, and regulations. Learning on the job, which used to be the de-facto for data managers, is no longer sufficient or an efficient way of learning. Structured courses, training programs, and graduate degrees are required to bring Clinical Data Managers’ knowledge and skills up to par with the state of the industry. This session will provide a few examples of professional development programs available to Clinical Data Managers.
Session Chair: Reza Rostami, MBA, CCDM, Associate Director, Quality Management, Duke Clinical Research Institute
Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience
CDM Certification Competencies: Education, Training, CDM Proficiency
Target Audience: Study Data Manager, DM Management, DM Programmer
Drug adherence and monitoring devices are designed to, remind patients to take their medication on time, compile/ deliver patient medication events/ dosing history to ensure that drug adherence monitoring is achievable and not solely contingent on patient completed diary cards. Additionally drug adherence/ monitoring devices can be used as part of the actual drug administration process to ensure that the recording of adherence monitoring data is not just accomplished but is also automated as part of the drug administration. This automation is performed as part of the drug administration workflow ensuring that there is a direct link between the actual drug administration and the drug adherence recording. Non-compliance drug administration events can also be recorded ensuring that this data can be used as part of the final study analysis. Visualizations analytics are also discussed as part of the drug adherence monitoring user-interface ensuring that drug adherence is not just analyses as part of final study report but made available to pharmacists/ clinicians. Availability of immediate adherence data (not restricted to just ‘pill-counts’) at the study visits enables a continuous and instantaneously assessment of drug adherence and allows a more robust adherence discussion to occur between the patient and the pharmacist or clinician.
Session Chair: Michael Duvenhage, CCDM, Clinical Trials Data Operations Manager, National Institute of Health / Leidos Biomedical Research, Inc.
Craig Brewczynski, Principal Data Manager, Astellas Pharma
Michael Duvenhage, CCDM, Clinical Trials Data Operations Manager, National Institute of Health/ Leidos Biomedical Research, Inc.
Darryl Pahl, Vice President and Co-Founder, DF/Net Research, Inc.
Session Level: Intermediate – Assumes comfort within CDM industry; 1-3 years’ experience
CDM Certification Competencies: Processing External Data, Clinical Trials Processes, Roles, and Responsibilities, Project Management
Target Audience: DM Management, Study Data Manager, Programmer, Clinical Program Leader
Clinical studies in academic institutions are much more diverse than in commercial research settings. In academic institutions, clinical studies range from randomized clinical trials, to observational studies, epidemiology studies, pragmatic studies, outcome studies, meta-analysis and so on. This session will examine how diversity of clinical studies and study design translate to skills and competencies for data managers.
Session Chair: David Kiger, VP Product Strategy and Marketing, PAREXEL Informatics
Jeff Beeler, Vice President of Product Innovation, Merge, eClinical an IBM Company
Karim Damji, SVP Product and Marketing, Saama Technologies
Jean-Remy Behaeghel, Sr Director, Clinical, Quality and Manufacturing Systems, Vertex Pharmaceuticals
Session Level: Advanced – Assumes solid knowledge of CDM industry; 4-6 years’ experience
CDM Certification Competencies: Electronic Data Collection, Data Management Plans, Clinical Trials Processes, Roles, and Responsibilities
Target Audience: Chief Data Officer, DM Management, Clinical Operations
Candace Shelton, MS, CCRA, CCDM, Vice President, Data Management, Imaging Endpoints
If you are considering professional certification or would like to learn more about it, please join us for the Becoming a Certified Clinical Data Manager (CCDM) session! This session will cover the current exam content and resources. The session will focus on preparing for the Exam including hearing from a panel of recently minted CCDMs!
Meredith Zozus, Associate Professor and Vice Chair for Academic Programs, Department of Biomedical Informatics, UAMS College of Medicine
Industry waited with baited breath for a new CDASH version; now the wait is over. CDASH v1.0 and v1.1 were said to be too stringent for companies with an established standards library. The CDASH team worked diligently to ensure v2.0 is more compatible with sponsors’ needs while still keeping conformant to the basic elements found in CDASH v1.0 and v1.1. Controlled flexibility has been included in the question text to allow companies to incorporate their special needs. Most importantly, the CDASH Model is now available for companies to use to create modules not currently available in the new version. CDASH v2.0 is the first foundational standard to be fully developed and published in the CDISC WIKI. CDISC is moving towards using the WIKI, rather than the traditional PDFs, for both the foundational standards and the Therapeutic Areas User Guides. WIKI navigation for the first time user can be tricky so we will take the participants through v2.0 to highlight some of benefits associated with the WIKI. As we continue to hear singles from regulatory agencies that CDASH may become a requirement, rather than a recommendation, how to appropriately implement CDASH is more important than ever. CDASH ensures full data traceability by using standards from the start. That should be a requirement in every company.
Dawn Kaminski, Director, Clinical Data Strategies, Accenture
CDM Certification Competencies: CRF Design, Clinical Trials Processes, Roles and Responsibilities, Clinical Database Design
Target Audience: Clinical Data Manager, Database Builder/CDC, Standards Officer
TransCelerate BioPharma created the eSource Initiative in 2016 to facilitate the industry’s movement toward optimal usage of electronic data sources. Despite advances in technology, data collection methods are not being utilized to their fullest capability, and transcription between electronic systems continues to be the norm. The methods and tools for collecting, representing and using clinical trial data and monitoring drug safety are severely outdated. The eSource Initiative strives to understand the current landscape, and identify the factors that influence the adoption of new technologies. TransCelerate will provide an overview of the landscape assessment including key findings from Sponsor, technology and use case perspectives. The details will include a discussion of the opportunities and challenges faced by multiple stakeholders. Cases will highlight the unique demonstration projects currently underway at member companies with the ultimate goal to modernize clinical trials. Survey results show companies are taking steps to leverage current eSource technologies and prepare for optimal utilization of electronic data sources. The TransCelerate eSource Initiative will continue to evaluate the technology, regulatory, standards, and healthcare landscape to support the improvement of global clinical science and trial execution. Forthcoming publications will focus on technology landscape, future vision, and demonstration projects. Presenters will discuss their experiences with esource case scenarios or demonstration projects.
Susan Bornstein, BA, MPH, Senior Director Data Monitoring and Management, Pfizer
Session Level: Expert – Assumes advanced understanding of CDM industry; 6+ years’ experience
CDM Certification Competencies: DM Management, Data Integration Specialist, Data Manager
Target Audience: Electronic Data Collection, Processing External Data
Krista Mullen, Director , Clinical Data Management, eClinical Solutions, LLC
Karen Reilly, MPH, Senior Principal Clinical Data Manager, Boehringer Ingelheim Pharmaceuticals, Inc
Lisa Squibb, Ph.D., MBA, MPH, Principal Clinical Data Manager, Boehringer Ingelheim Pharmaceuticals, Inc
Damon Fahimi, Product Specialist, Uppsala Monitoring Centre
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.
The audience will have the chance to cast their vote and act as the 4th judge!
The winner will be entitled to a full page ad in Data Basics (SCDM’s quarterly peer reviewed journal) to showcase their project, product or company (value: $1,064), and will be mentioned on SCDM’s social media platforms.
Charlene Dark, Director, Integrated Processes and Technology, Quintiles
It has been over 10 years since CROs and pharma companies began offshoring data management activities. What has changed for data managers in the US and Europe? What does this mean for the future of data managers in the US, Europe and these low cost countries? Has this really saved costs? Are there good processes in place to ensure and measure quality? Do staff in all of these roles have access to the training they need? Do staff in low cost countries have the opportunity to progress in their careers? Do people see further changes coming in their companies? This panel discussion will discuss the answer to these and other questions and open the floor up to the audience to share their thoughts and experiences.
Session Chair: Susan Howard, Director, Data Management, Adaptimmune, LLC
Session Level: Novice – Assumes some knowledge of the CDM industry; 1 year experience
CDM Certification Competencies:Clinical Trials Processes, Roles, and Responsibilities, CRF Tracking and Communication of Data Trends, Data Management Plans
Target Audience: Study Data Manager, DM Manager, Programmer
This session will present the perspective of site monitors and how they, and the sites themselves, interact with today’s data management tools and processes. The presentations will provide insight into both the challenges and benefits of implementing data management centric tools and processes at the clinical site and what impact this has on the site staff and the site monitors. In addition it will explore underutilized technology and opportunities for clinical monitors to streamline their review of data either at or away from the site. Finally, the session will surface and address the complex relationship between clinical site monitors and data managers, how they interact with each other and the impact this has at the site.
Steve Shevel, Senior Associate, Waife and Associates, Inc.
CDM Certification Competencies: Project Management, Clinical Trial Process, Roles and Responsibilities, CFR Tracking and Communication of Data Trends
Target Audience: DM Management, Study Data Manager, Clinical Manager
Dr Joby John, Senior Director, eHealth Operations, BioClinica, Inc.
CDM Certification Competencies: DM Management, Study Data Manager, Study Build Programmer
Target Audience: CRF Design, Data Query Processing and Tracking, SAE Reconciliation and Safety Review
Scalable implementation of risk based monitoring (RBM) involves a significant component of centralized monitoring. Executing central monitoring in clinical data operations (CDO) is evolving rapidly and tends to be focused primarily on review of subject/ site level data and or aggregate data. On the other hand, technology and data science has enabled automation and statistical modeling that can potentially miss specific context and softer aspects of clinical trial conduct. These two approaches are either being used in isolation or in a non-cohesive manner within organizations that leads to sub-optimal clinical data monitoring. There is scope for significant improvement to bring an integrated and holistic approach to central data monitoring. The intent of this session is to bring out key models being used in central monitoring and then propose how a modified central monitoring approach will benefit the industry. This session topic will focus on describing: 1. Current central data monitoring approaches utilized by CDO in the industry using examples.2. Implementing central data monitoring in a modified framework using case studies or proof points. The session will include 4 speakers (including session chair) with experience and expertise in implementing centralized monitoring who will cover the following topics in their presentations.
Abby Abraham, M.Pharm, PGDHHM, Vice President – Clinical Solutions, Algorics
CDM Certification Competencies: Protocol Review, Data Management Plans, Communication of Data Trends
Target Audience: Study Data Manager, Head of Clinical Data Management, Clinical Data Monitor
Clinical Research has come a long way since using paper in the 1990s. Most studies have adopted electronic solutions with rapid improvements in connectivity and wide availability of clinical technology solutions. With the growth of the clinical research industry in established geographies and expansion of research in emerging countries, organizations have been using electronic data capture to improve accuracy and speeds of patient data collection methods, which has helped to increase compliance with regulations as well as reduce costs. With improving technology, mobile and handheld device proliferation, innovative study designs and evolving regulations including those for global data security and privacy, we are witnessing trends in clinical development that are looking to better utilize the latest technology and appropriate data collection devices. There are several key trends that are particularly notable including: 1) Increasing use of ePROs in studies; 2) Bring your own device (BYOD) for electronic clinical outcome assessments (eCOA) or electronic patient reported outcomes (ePRO); 3) Electronic Health Records (EHR) integration with EDC; 4) eSource adoption; 5) Mobile health (mHealth); 6) Utilizing deidentified healthcare data to suggest sources of potential patients for clinical trials and improvement of protocols and study designs; 7) Direct to patient trials (virtual clinical trials). In this panel discussion, we will discuss such latest developments, benefits and challenges.
Session Chair: Arshad Mohammed, Senior Director, Data Sciences, QuintilesIMS
Session Level: Advanced – Assumes solid knowledge of cOM industry; 4-6 years’ experience
CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Electronic Data Collection, Project Management
Target Audience: Data Manager, Programmer, DM Management
As patient-centric medicine and a focus on effectiveness continue to dominate the healthcare and research landscapes, patient reported outcomes are becoming more essential to the design and conduct of clinical trials. Driven by demand from both payers and regulatory agencies, traditional methods of ePRO data collection (provisioned devices, existing instruments) are often costly and cumbersome, and fail to deliver the highest possible quality of outcomes data. We must engage patients on their time, through their channels, in order to maximize the completeness, timeliness, and accuracy of reporting. Join this panel to hear from a representative cross section of seasoned trial leaders on how they pushed their ePRO initiaves from good to great, by implementing “bring your own device” (BYOD) whenever possible and offering better training and support to study subjects when provisioned devices were necessary. This session is applicable for all conference attendees, but ideal for trial leaders and data managers with limited experience in trials incorporating these strategies.
Session Chair: Ben Baumann, Co-Founder and Chief Operating Officer, OpenClinica, LLC
CDM Certification Competencies: Electronic Data Collection, Clinical Trials Processes, Roles, and Responsibilities, Processing External Data
Target Audience: Study Data Manager, COA Lead, Regulatory Director
China Pharmaceutical industry has gone through dramatic changes recently with many regulations released and CFDA actions implemented having great impact to clinical trial data management practice and NDA data submission. Presenters in this session are China clinical data management area industry leaders from international pharmaceutical company, China top domestic pharmaceutical company and China CROs. They will introduce in details about new CFDA regulations, China NDA required clinical data management reports, as well CFDA data inspection related integrity checks, et al. The session will provide an in-depth view of China regulations and evolutions in clinical trial data management, as well as the most recent update for China market clinical data management capability.
Session Chair: Carrie Zhang,CEO, eClinWise, Panacea Technology Co., Ltd
Daniel Liu, Ph.D., Chief Scientific Officer, Beijing Clinical Service Center
Charles Yan, VP, Global Clinical Data Science Center, Hengrui Medicine Co., Ltd
Anita Shen, Director, China Data Management, Janssen of Johnson & Johnson
Carrie Zhang, CEO, eClinWise, Panacea Technology Co., Ltd
Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Data Management Plans, Data Base Quality Control Audits
Target Audience: Pharmaceutical Company Leader, CRO Leader, Study Data Manager, DM Management, Clinical Trial Outsourcing Professional
Clinical research data pass through several environments from the point of generation through to clinical study report, dashboard, warehouse, or whatever other roles they may fulfill. CDISC’s CDASH and SDTM standards are instrumental in supporting data consistency, structure, integrity and traceability. Both standards are needed for this process to work. The presentations in this session will explore how both standards work together in optimizing a sponsor’s outsourcing to multiple vendors, in creating integrated data and dashboards in an academic/ government research environment, and in ensuring that the unique needs of both data collection and tabulation are met in a transparent format.
Session Chair: Kit Howard, MS, CCDM, Director of Education; Co-Chair Medical Device Standards Development, CDISC
CDASH Metadata for Efficient SDTM Development and Consistent Database Builds With Multiple Vendors
Adopting CDASH and SDTM for Clinical Trials and Dashboards
CDISC’s CDASH and SDTM: Why You Need Both!
CDM Certification Competencies: Data Standards, Electronic Data Collection, Clinical Database Design
Target Audience: Clinical Data Manager, Data Capture (CDASH) and Tabulation (SDTM) Programmers, Data Capture and Database Standards Managers
We keep doing the same things over and over without making any notable improvements in process during a clinical trial. This panel discussion is aimed at bringing together sites, monitors and data manager perspectives on one stage. The discussion will be source document verification, electronic medical records, eSource and other items impacting clinical trials. How can we work more effectively together to help improve the world of clinical research?
Jonathan Andrus, BA, MS, CQA, CCDM, COO and Data Officer, Clinical Ink, Inc.
CDM Certification Competencies: Electronic Data Collection, Clinical Trial Processes, Roles and Responsibilities, DB Quality Control
Target Audience: Data Manager, Clinical Manager, Clinical Trial and DM Management
Clinical trial programs have grown in complexity, scope and scale. Electronic systems have enabled fewer people to manage larger and larger scale projects with higher quality. Further, with the advent of electronic data collection and submissions, regulators are raising the bar for what is expected for clinical trial data to be accepted as credible, corroborated, and consistent. Paper models and processes (converted to electronic) are no longer sufficient and the landscape is changing swiftly. Discover from those have been there and done that!
Hopkins University uses 3 monitors to manage over 200 sites worldwide with 120+ page case book and uploaded CT-Scans. A global pharmaceutical company has a sequence of VAS scales randomly assigned to Phase 1 patients, timed and controlled by the site coordinator. But animals are patients with data to manage also. Atlanta Zoo maintains a global registry of all great apes and tracks their heart disease with more than 65 institutions in 10 countries including pathology findings. Another pharmaceutical company has animal health projects that includes identification of patients via RFID, calculates wound area with tracing a photograph on a tablet, patient diaries are completed via the internet. Aratana pharmaceuticals will share their perspective and lessons learned through carrying out multiple studies using EDC in multiple sites.
Integration of disparate data sources makes the data management role more complex and gives rise to platforms where data managers must learn and support a wide range of studies, study types, and build types (from DIY to full-service) and supports greater consistency, efficiency, and reuse as studies progress between phases and complexity with emerging technology.
Though this panel’s collective experiences, you will gain insight to keep up with the evolving landscape for data collection processes and procedures. Speakers will present case studies and describe the issues they encountered and how they collaborated to resolve them obtaining cleaner data faster with higher quality with the goal of submitting results sooner to regulatory agencies for approval and fewer queries about that data.
Session Chair : H Karina Loyo, Ph.D., M.B.A., eClinical Specialist, Prelude Dynamics LLC
Alicia Browner, Ph.D., Chief Technology Officer, Prelude Dynamics LLC
Karen Lane, CCRP, Administrative Director and Research Project Manager, Department of Neurology’s Brain Injury Outcomes Division, John Hopkins University
Jessica Wofford, DVM, Ph.D, Project Manager, Drug Development, Aratana Therapeutics, Inc
Certification Competencies: Electronic Data Collection, Project Management, Clinical Database Design, Clinical Database Design, Clinical Trials Processes, Roles, and Responsibilities
Target Audience: Study Data Manager, Study Manager, Study Clinical Director
This session will get you thinking about possible solutions you could implement early on in the clinical trial lifecycle to ensure you make, and even possibly beat, your DB Lock date. Based on the real world experience of our speakers they will provide their tips and best practices on how to: plan, track and determine the status of all data clean at a point in the study. There are lots of ways in which we can use the data collected and our various technologies to advance the goal of knowing where you are and if you will achieve one of the most important milestones in your study on time, DB Lock.
Karen McPoyle, Director, Data Strategy & Solutions, BioClinica, Inc.
Session Level: Advanced Expert – Assumes deep knowledge of the CDM industry; 8+ years’ experience
CDM Certification Competencies: Clinical Trials Processes, Roles, and Responsibilities, Project Management, CFR Tracking and Communication of Data Trends
Target Audience: Clinical Data Managers, Clinical Project Managers, DM Management
Kassa Ayalew, M.D., M.P.H., Branch Chief for Good Clinical Practice Assessment at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation, Center for Drug Evaluation and Research (CDER), FDA
Kassa Ayalew will share his expertise from an institutional perspective on international clinical trials. It promises to be a highly valuable session, for all those involved or interested in managing international clinical trials.
The number of clinical trials sites located at non-U.S. sites which contribute data in support of U.S. marketing applications for drug approval is increasing. Clinical trials in support of regulatory submissions to FDA must be conducted in accordance with FDA regulations to assure the safety, efficacy, and ethical development of medical products whether the clinical studies are conducted in the U.S or abroad. This presentation is designed to advance the understanding of the FDA’s perspectives on clinical trials conducted outside the U.S for U.S NDA/BLA submissions, with an emphasis on distribution of data in FDA submissions, and U.S. law governing foreign clinical trials. GCP validation of data obtained through onsite inspections to assure data quality, integrity, and ethical development of medical products will also be discussed.
Join us for an exclusive ‘Black & White Night’, taking place at the Grande Lakes Da Vinci Terrace & Lawn. Enjoy a series of savory selections & drinks with a local flavor, accompanied by buzzling entertainment!
Dress Code: Black & white, be creative!
Fee: $80 per person
Start your educational experience at the Annual Conference with the Opening Reception!
Meet the top industry leaders, in one place, to learn more about industry trends. An opportunity for excellent networking opportunities.
Appetizers and refreshments will be served in comfortable exhibition facilities. A must-attend event.
Join us at the second SCDM Fair edition at this year’s SCDM Annual Conference!
This is your opportunity to meet the SCDM volunteers and learn about what is going on behind the scenes. Representatives of each SCDM Committee and Task Force will be present to discuss their progress with their respective Committee or Taskforce. Ask them your questions in an informal and interactive setting, just before the opening of the exhibition!
Dave Izard, Senior Director, Clinical Data Standards, Chiltern International, Inc.
CDM Certification Competencies: CRF Design; Clinical Trials Processes, Roles, and Responsibilities; Clinical Database Design/Relational Data Bases
Target Audience: CDM Leadership, CDMS Programmer, Study Data Manager
Continuing Education Credits: SCDM is authorized by IACET to offer 0.4 CEUs for this program.
Debra Jendrasek, Vice President, Strategic Development Partner, Chiltern International, Inc.
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
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, the sector presents a variety of challenges. For small to mid-sized firms, straying from traditional monitoring may seem daunting. This team of experts will help lay out the key concepts for 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 presentation will provide the audience with different CRO and Sponsor perspectives on supporting and working within a Risk Based Model.
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 Biometric functional area representatives that would like to gain an understanding of Risk Based Monitoring, ICH E6 (r2) updates and how these items affect their role within a clinical trial.
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:
BYOD Considerations and Lessons Learned in an Ongoing Clinical Trial
A 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.
EHR to EDC; A Case Study of Two Unique Approaches and Outcomes
Rakesh Maniar, Senior Director, Novartis
The tenth 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 submit ask their questions during a survey period prior to the session as well as during the Q & A portion of the session.
Do not miss the chance to determine what’s critical to our regulators, to your peers, to you and your organization.
Jonathan Andrus, BA, MS, CQA, CCDM, COO and Data Officer, Clinical Ink, Inc.
Including all items:
Branding & Advertising
Exhibition & Registration
Unique to this Package
A la Carte Gold Menu (Choice of 1)
A la Carte Platinum Menu (Choice of 1)