Connect Streams

Stream

Stream Description 

Stream Chairs

Analytics, Big Data & Statistics
(AS)

The Analytics, Big Data & Statistics Stream is designed to allow members to share ideas on the interface between statistics, analytics and computing, as well as innovative ideas to analyze and manage the big data in our industry. This can be software-related, for example how computing packages can be used to resolve data analytics or statistical issues within the clinical trial field. It can also be statistical in nature, such as improving programmers' understanding of new innovative statistical and analytical methods, or describing statistical/analytical/programmatic approaches in specific areas (e.g. PK/PD; statistical modeling; analytical techniques – use of SAS Graph or R; use of adaptive designs vs. group sequential designs and their implementation, analysis and presentation of biomarker data; analysis of outcomes data; use of registry data and historical or case controls for orphan indications, to name but a few).


Vidya Muthukumar


Mike Litzsinger


Eileen Ching

Centralized Monitoring
(CM)

The purpose of the Centralized Monitoring Stream is to share innovative approaches in leveraging real-time access to clinical data and analytics to proactively manage data quality and subject safety risks. Operational execution of a sustainable data monitoring strategy in clinical development requires a seamless risk-based approach for centralized monitoring of critical data in real time, from first patient in through to database lock. This approach requires leveraging and relying on new modalities, predictive modeling, analytics, visualizations, and approaches for identifying and monitoring critical endpoints, key risk indicators (KRIs), associated data and processes required for collection of those data. The Stream is encouraging industry to come forth with their ideas and implementation strategies using statistical programs and visualizations that are then used by central monitors, clinical research associates (CRAs), trial managers, data managers, and others to monitor data and address risks throughout the study.


Adrienne Strickler


Bhavin Busa


Andy Miskell 

Coding Tips & Tricks
(CT) 

The Coding Tips & Tricks Stream is dedicated to brief presentations on real-life code, programming tips and best practices, efficiency techniques, undocumented/new features, useful algorithms, macros and other creative uses of software. This session is the perfect forum for beginners and experts alike to share coding tips and tricks that can transform the current state, with techniques that increase efficiencies or provide time/cost savings. If you have found an innovative solution to solve a challenging problem, come share it with the statistical programming community.


Avinash Reddy


Twaha Bukenya


Sunil Gupta

Data Handling
(DH)

The Data Handling Stream encompasses the entire lifecycle of data flow in drug development. Data quality, validation and acceptance, analysis, de-identification, transparency, traceability, data mining/sharing, warehousing, operational design, and implementational strategy are just a few of the categories where breakthrough thinking and novel approaches to data handling can transform our industry. As more focus is placed on patient and investigator experiences, technology-driven solutions and streamlined submission compliance, data handling innovation is crucial in our journey to provide patients with life-changing and affordable therapies.


Anupama Sheoran


George Stuts


Judy Tran

Data Visualization
(DV)

With the explosion in the amount of data collected and analyzed, the use of graphical displays to understand and communicate clinical research data is now more critical than ever before. The human brain is highly developed at pattern recognition and better at visualizing graphical presentation of clinical research data than seeing a tabulation of lots of numbers. Summary tables provide a necessary level of detail to understand the nuances of means, medians, variances, p-values, etc. to support the graphical displays; however, line plots, bar graphs, pie charts, and more complex two- and three-dimensional static and interactive graphs to visualize the data are far more effective. In addition to viewing summary data displayed graphically, visualizing individual subject data as patient profiles allows for better understanding efficacy and safety for each subject in a clinical trial rather than reviewing data listings, spreadsheets or eCRFs.

The Data Visualization Stream focuses on data visualization examples, tools and techniques that can be applied to better understand data to support improved decision-making in drug development.


Lisa Lyons


Karnika Dalal


Munish Mehra

Data Standards & Governance
(DS)

Effective implementation and governance of CDISC data standards is the recommended foundation for efficient collection and analysis of data across studies and sponsors. It is also key to ensuring that data are fit for use by regulatory authorities and other key data consumers. The Data Standards & Governance Stream focuses on how companies are embedding the foundational aspects of existing and future data standards into their business processes. Topic areas include: underlying concepts, descriptions, explanations, interpretations and processes designed to support the implementation, management and governance of these data standards.


Ellen Asam


Deidre Kreifels


Narasimha Ayyalas

Leadership
(LE)

Recent notions of leadership focus on cultivating followers by guiding and mentoring to ensure collective performance. True Leadership is more than this: it is about developing people, helping others reach their full potential while strategizing to ensure company needs are realistic and achievable. The Leadership Stream will apply innovative, creative and engaging approaches to each of the sessions, with a view to creating take-away messages for everyone regardless of level or role. Open to everyone, the Leadership Stream is working to engage some excellent presenters to help stimulate and lead the debate. 

(Presentation is by invitation only; ALL are welcome to attend the sessions.)


Karen Curran


Gina Wood


James McDermott

Machine Learning & Artificial Intelligence
(ML)

 

 

 

The current field of artificial intelligence (AI) grew out of academic theories from the 1950s. It has been refined over decades and, combined with a steady progression in computing power, has transformed the mere idea of AI into reality. AI itself encapsulates many subfields such as machine learning, natural language and speech processing, automated reasoning, knowledge representation, neural networks, evolutionary computation and algorithms, and deep learning, to list but a few. The Machine Learning & Artificial Intelligence Stream is focused on introducing the community to these topics and exploring how we can utilize these approaches to drive clinical drug development and better outcomes for patients.


Michael Rimler


Feryal Tanriverdio


Edita Karosiene

Non Specific
(NS)

This stream is in place for those papers that do not fit directly within any of the established Connect streams, so that the Conference Chair and Co-Chair can take the decision on where the paper would best be presented. The focus is to provide a storage point for the paper until an actual stream has been determined and agreed with the author(s). 


Trisha Simpson


Michael Badlani

Posters
(PP)

 

 

A poster is worth a thousand words, and an hour of conversation and networking. Poster Presentations provides an opportunity to cover any of the Stream topics in a visual and engaging manner. Posters are ideal for presentations that include graphics, source code, statistical or thought-provoking concepts, novel data management or handling techniques, innovative ways to implement data standards, and much more.

Posters increase visibility, allow participants to review at their own pace, and provide for engaging in conversation to discuss the topics presented.


Kala Shivalingaiah


Parag Shiralkar


Yongqiu Yvette Liu

Submissions & Agencies
(SA)

The regulation of clinical data is governed by constantly evolving rules, standards and regulations on data transparency and protection, GxP, ICH, 21 CFR Part 11 compliance, validation, version control, process management and continuous improvement processes. Clinical data is regulated in all aspects of submission-related activities including interactions with health authorities, site inspections and audits. The Submissions & Agencies Stream invites you to share your experiences and have open discussion on the challenges and benefits of working in a highly regulated industry.


Sangeeta Bhattacharya


Jane Marrer

Software Demonstrations (SD)

The Software Demonstrations Stream focuses on the demonstration of new or recently released software and tools. It may include new programming platforms, reporting systems or data management tools and new innovative applications utilizing a variety of new and established technologies. Each demonstration has the goal of highlighting potential for enhanced optimization, increased efficiency or user-friendliness in the day-to-day undertaking of biometrics processes and tasks.


James Vasquez


Todd Case


Sairam Gorthi

Standards Implementation (SI)

 

 

 

 

The Standards Implementation Stream is dedicated to the implementation of industry standards, such as those from CDISC (e.g. SDTM, ADaM) and document standards (e.g. eCTD), to support the acquisition, exchange, analysis, submission and archival of clinical data and metadata in life sciences and the pharmaceutical industry. This Stream focuses on the implementation of these standards using scripts, macros or tools (that are not platform-specific) to encourage standards-based research that leads to quality enhancements and process streamlining.


Renu Shukla


Hanming Tu


Kristen Kelly

Strategy & Programming
(SP)

The Strategy & Programming Stream examines some of the softer skills. As an industry, we often focus on the common programming languages, data standards and technology, but there is more to making us efficient and successful within the work environment. With an ever-changing environment, staff have more opportunities to learn and move around, giving more importance to how we retain the right people. With our distributed model of working within global teams, management of this diverse team and quality of the deliverables becomes a key activity for all managers. In our group of presentations, we will learn how we can cope with these challenges.


Roopali Lakhe


Cindy Stroupe


Abhishek Mittal

Trends & Technology
(TT)

The Trends & Technology Stream concentrates on the many new and emerging trends within life sciences that have an impact on those working with data. These could include hot topics driven by external factors such as public opinion and the application of innovative technologies in the life sciences sector.


Suhas Ramesh Sanjee


Mary Vaugheses


Yuguang Zhao

 

 

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