Connect Streams

StreamDescriptionChair / Co-Chair
Analytical Risk-based Monitoring

The purpose of this stream is to share innovative approaches leveraging real-time access to clinical data and analytics in proactively managing clinical operation risk. Analytical Risk-based Monitoring (ARBM) is a growing field in clinical trial execution. Operation execution of a sustainable risk management strategy in clinical development requires a seamless approach for review of critical data in real time. This approach requires leveraging and relying on new modalities, analytics and approaches for identifying and monitoring critical data. During set-up and execution, this requires a process for identification and monitoring of critical endpoints, associated data and processes required for collection of those data.

Shafi Chowdhury

&

Sina Djali

Analytics & Statistics

The Analytics and Statistics stream is designed to allow members to share ideas on the interface between statistics, analytics and computing. 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 statistical and analytical methods.

Corinna Miede

&

Alex Hughes

Application Development

Papers within the Application Development stream typically cover the development (including implementation and integration into existing environments and processes) of applications and software designed to assist us in our daily job, either directly or indirectly. Papers can also cover migration projects and current software development methodologies (e.g. Agile).

Stephen Griffiths

&

Hervé Guimard

Career Development

The Career Development stream showcases a diverse range of presentations. From the day we start our career to the day we retire we will face new challenges in our daily working life that need us to react to changing skill sets, working practices, areas of research and technology, while having an eye on the future and other industries, to remain flexible. This stream delves into the range of soft skills required to thrive in this changing environment and the techniques that can be employed to achieve them.

Kathryn Wright

&

Jorine Putter

Coding Tips & Tricks

Coding Tips & Tricks is dedicated to brief presentations on real-life code, programming tips, efficiency techniques, undocumented features, useful algorithms, macros and other creative uses of software.

John van Bemmelen

&

Kriss Harris

Data Handling

The Data Handling stream is dedicated to many aspects of data handling and database management in life sciences and the pharmaceutical industry. These aspects include extraction and transformation of raw data, metadata definition and handling, data quality, validation and acceptance, analysis data processing, data de-identification and transparency, data mining, master data management and clinical data warehousing. With the increasing complexity of clinical trial data and greater emphasis on delivery of high-quality, submission-ready data, state-of-the-art novel data-handling techniques for managing clinical data are needed and appropriate for this stream.

Joerg Guettner

&

John Moone

Data Standards & Governance

The structure and semantics of clinical data has become the subject of regulated standardisation, being mainly defined by various CDISC data standards and the respective documentation requirements. Many of these particular standards are integrated into super ordinated frameworks, like BRIDG, SHARE, RDF. Effective implementation and governance of standards becomes vital for the acquisition, exchange, analyses, archival and submission of clinical data and metadata.

This stream focuses on the foundational aspects of existing, as well as future, clinical data standards, covering topics like the underlying concepts, descriptions, explanations, interpretations and processes to support the implementation, governance and compliance.

Michael Knoessl

&

Beate Hientzsch

Data Visualisation A picture is worth a thousand words! For centuries, people have depended on visual representations such as charts and maps to understand information more easily and quickly. We collect massive amounts of data during the course of a clinical study, which cannot be digested just by looking at tables and listings. How do we communicate information clearly and efficiently to users? Data visualisation is this powerful technique that is used not only to communicate with the scientists but also to understand, interpret and even clean the data. The DV stream focuses on data visualisation examples, tools and techniques which can be used in our field to leverage data to better support drug development.

Vincent Buchheit

&

Holger Langkabel

Hands-on Workshops

(Stream content by invitation only)

Hands-on and interactive workshops.

(Stream content by invitation only) 

 

Paula Finch, Mark Foxwell & Jennie McGuirk

 

Machine Learning The topic of machine-driven intelligence has long been a realm mostly occupied by science fiction and futurist speculation. Academic theories from the earlier parts of the 20th century, refined over decades and combined with a steady progression in computing power, have turned the possibility of machine learning and artificial intelligence into a reality. This stream is focused on introducing the community to the topic of machine learning and artificial intelligence and exploring how we can utilise these approaches to drive clinical development and better outcomes for patients.

Ian Fleming

&

Azad Dehghan

Management

(Stream content my invitation only)

This year, the Management stream will be focusing on three hot topics covering innovation, talent
development and changing landscapes. Following on from last year’s success, we will continue to apply innovative, collaborative and engaging approaches to each of the sessions, with a view to creating take-away messages for all. Open to everyone, this year’s Management stream is again set to be interactive and fun, and we have some excellent presenters lined up to help stimulate and lead the debate in each area.

 

Jasmine Kestemont, Leanne Johnstone & Jennifer Dootson

 

Posters Posters covers a wide variety of topics in a poster board rather than a formal lecture. Posters are ideal for presentations that include graphics, source code, statistical concepts or thought-provoking concepts that invite participants to review at their own pace.

Jinesh Patel

&

Anne-Sophie Bekx

Real-world Evidence The Real-world Evidence stream is dedicated to the handling and analysis of all kinds of observational data including but not limited to registries, health claims and medical records databases, and non-interventional prospective and retrospective studies. The stream will focus on a programmer’s perspective on the challenges the analysis of real-world data holds, such as extremely large data sets, dealing with dirty data, integration with RCTs and issues with regard to validation and standardisation. These challenges need to be dealt with and require specific analysis methods and programming techniques, such as data standardisation, matching algorithms, propensity scores and various kinds of sensitivity analyses.

Berber Snoeijer

&

Alistair Dootson

Scripts & Macros Statistical programmers are exposed daily to repeated tasks. The use of macros such as SAS macros, or, more generally, script languages such as Visual Basic, JavaScript, DOS, etc. does facilitate the automatic execution of these repeated tasks. Moreover, organisations do create SAS macros or R routine libraries to cover statistical package “gaps” such as new statistical method and statistical graphic representation not yet implemented, standard derivation algorithms or any innovative methods to handle and retrieve data. The Scripts and Macros stream encourages users to share practical examples to show the use of the most common script languages and how they can be used in everyday statistical programming activities to save time on repeated tasks. Examples are, but not limited to, DOS, to automatically batch-execute a set of SAS programs, and a SAS macro library, to handle standard CDISC derivations.

Angelo Tinazzi

&

Elena Glathe

Software Demonstrations Software Demonstrations 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 utilising a variety of new and established technologies. Each demonstration has the goal of highlighting potential for enhanced optimisation, increased efficiency or user-friendliness in the day-to-day undertaking of biometrics processes and tasks.

Cathal Gallagher

&

Martin Gregory

Standards Implementation The Standards Implementation stream is dedicated to the implementation of industry standards, such as CDISC, to support the acquisition, exchange, analysis, submission and archival of clinical data and metadata in life sciences and the pharmaceutical industry. The stream focuses on the implementation of these standards using scripts, macros and tools that are not coding language and platform-specific. 

Edwin van Stein

&

Nick De Donder

Submissions & Agencies  The Submissions and Agencies stream focuses on sharing knowledge, experience and best practice in the preparation, delivery and defence of submissions in the current environment of regulations that include standards and guidance from government agencies. Encompassing all aspects of submission-related activities such as interactions with health authorities, site inspections and audits, we invite you to share your experiences, and welcome open discussion on the challenges and benefits of working in a highly regulated industry.

Stephen Harrison

&

Ken Stoltzfus

Trends & Technologies

 Trends and Technology papers concentrate 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 new technologies in the life sciences sector.

Rob Horton

&

Elsa Lozachmeur

 

 

 

 

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