Emerging Trends & Technologies

Working Group & Project Scope

Working Group Leads

Andy Richardson

Dhananjay (DJ) Chhatre 

Initiated in 2013, this Working Group aims to provide an open, transparent forum for cooperatively sharing and investigating how new technologies, tools and approaches can support clinical data science. The projects are selected with the aim of assessing, understanding, describing, instructing and offering guidance about how new technologies can be used in the development of new medicines. The projects range in scope from investigations into new technological innovations and how they can be used, through to guidance and training for new and developing standards, as well as metrics and benchmarking initiatives to support successful operational implementation. 

Blockchain Technology

Disa Lee Choun

Adama Ibrahim

Aji Barot
 

This project introduces blockchain, describes how it works and discusses the pre-requisites for adopting blockchain. Members explore the qualities of blockchain relevant to the pharma setting, looking at examples of use cases and applications. Collectively, project members provide high-level analyses of the pros and cons of blockchain in pharma and healthcare.

Cloud Adoption in the Life Sciences Industry

Anders Vidstrup

Cloud technology and its use of multi-tenant app solutions is increasing the capabilities of life sciences solutions and reducing IT infrastructure costs through the sharing of infrastructure and investment cross-industry. The goal of this Working Group project is to provide a practical, usable framework to address the barriers pharma face in adopting cloud-based technology.

Data Visualizations for Clinical Data 

Mike Rubison

The FDA Guidance on a Risk-Based approach to Monitoring (August 2013) opened the door to using scientifically founded monitoring solutions as alternatives to 100% source verification of clinical data. Individual companies have proposed a range of opportunities to look at the applicability of data visualisation within the pharmaceutical environment that addresses cross-domain questions and insight associated with RMB.

Investigating the Use of FHIR in Clinical Research

Trisha Simpson

Geoff Low

Increasing interest in eSource keeps the issue of data integration between research systems (EDC, CTMS, CDMS, etc.) and healthcare systems (EHR etc.) as a consistent want for sponsors, clinical investigators and regulators. The new PHUSE Working Group project Investigating the Use of FHIR in Clinical Research looks at how the HL7 FHIR standard could be used as a fundamental part of the clinical trial process in the future.

Open Source Technologies in Clinical Research

Gayathri Kolandaivelu

Frank Menius

Eli Miller

Michael Rimler

Michael Stackhouse

Open Source Technologies in Clinical Research aims to provide guidance to the use of open source technologies in regulatory environments within the pharmaceutical industry, including but not limited to R and Python. Our intent is to be a repository of knowledge for: 

• Use Cases 

• Implementation and validation guidance

• Best Practices

Our goal is to broaden the acceptance and general level of comfort with these technologies in the industry to assist in increasing their level of adoption  

Real World Evidence 

David Hood

Sangeeta Bhattacharya

The increasing interest/pressure to including results based on real world data as part of regulated clinical trial submissions and similar research initiatives is testing how current regulatory and good practice requirements can incorporate these results into submissions. Whilst specific projects have successfully addressed these issues, RWE guidelines or points for consideration are not yet formalised. This project aims to focus on the issues within Real World Evidence and develop a White paper which establishes a range of areas that need to be considered/impact the use of RWE in support of regulated clinical trial submissions.

 

 

 

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