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Welcome!

Interested in joining one of the Data Transparency Emerging Trends & Innovation Working Group Projects? The projects below are currently calling for volunteers.

AI/ML in Digital Health Technologies (DHTs) – Started Q

Project Scope:

The use cases of artificial intelligence and machine learning (AI/ML) in digital health technologies to improve healthcare through software.

Understand the challenges, and identify the gaps. Connect different stakeholders, share knowledge, and advance in developing AI/ML in DHTs.  

Current Status:

  • Q1 2025 Forum with proposed date and speaker

Regular Project Meeting Day/Time:

  • ?

Key Skills:

  • Experience with the use of DHTs

  • Experience with AI/ML

Cloud Adoption in the Life Sciences Industry – Started Q1 2019

Project Scope:

Cloud technology and its use of multi-tennant app solutions are increasing the capabilities of Life Sciences solutions and reducing IT infrastructure costs through the sharing of infrastructure and investment cross-industry.

In some areas multi-tenant cloud solutions have become ubiquitous. For example, Salesforce.com claim >150K customers utilise their platform for Customer Relationship Management. Furthermore, many routinely rely on Cloud services associated with their computer backups and data services associated with cell phones.

Nonetheless, the perceptions and interpretations of the regulations by which the Life Sciences industry must conduct its business still leave many uncertain about whether or not they can (or should) pursue the use of Cloud solutions for GxP applications.

The goal of this project has been to provide a practical, usable framework to overcome those barriers. Through the use of this framework, it is envisaged that the barriers to adoption by Pharma of Cloud-based technology will be addressed.

Current Status:

  • Draft for exit strategy document

Regular Project Meeting Day/Time:

  • Bi-weekly: Thursdays 4-5pm GMT

Key Skills:

  • Experience in cloud-based technology

  • Experience with GxP applications

  • Experience ???

welcome new volunteers.

Investigating the Use of FHIR in Clinical Research – Started Q Q1 2021

Project Scope:

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 of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with wide-scale adoption, for a variety of reasons.

Some common historical points of view have included:

  • That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.

  • That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.

  • Types of data captured in healthcare have been more operational rather than clinical.

  • Enabling the Necessary interfaces is an expensive and process-heavy undertaking.

  • There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.

Many of these issues are on the path to being resolved; government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator.

Current Status:

  • Jan 25 Connectathon PoC with SDC.

Regular Project Meeting Day/Time:

  • ?

Key Skills:

  • Experience with HL7 Vulcan

  • Experience with FHIR

  • Experience in writing Use CasesCalls have moved over to Vulcan, which the Lead will add you too.

Key Skills:

As a combination business and technical group we value input from all parts of the process of data management in Healthcare and Clinical Research. Specific skills that would benefit us include:

  • Experience with Business Process Analysis

  • Experience with Healthcare Data Management (including EMR/EHR systems, HL7, HL7 FHIR)

  • Experience with FHIR Profiling (extensions, profiles and Implementation Guides)

  • Understanding of the data management lifecycle, with a special interest in innovation

  • Experience with Python

QC Workflow Optimisation – Started Q1 2025

Project Scope:

  • State of the union: how QC is broadly performed across the industry

  • What obstacles does double programming introduce when it comes to accelerating and making use of modern technology and techniques?

  • Alternatives to the current process

  • What impact does the adoption of Agile methodology have on the current QC process?

  • What are other regulated industries, such as banking and insurance, doing?

  • What is the cost of QC, and does changing the process impact on the cost positively or negatively?

How might the increasing use of AI change the QC process?

Current Status:

  • Project Approved

  • Project Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: April 30 2025

Key Skills: (currently being reviewed by WG Leads)

Integration of Omics data into Clinical Drug Development – Calling For Volunteers Soon!

Project Scope:

  • Establishing best practices when working with BioCompute

  • A guide for creating and validating BioCompute Objects

  • Submission considerations for BioCompute Objects

  • Sharing of BioCompute Objects across the industry.

Current Status:

  • Project Approved

  • Project Soon To Be Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: TBC

Key Skills: (currently being reviewed by WG Leads)

The Use of Git in Statistical Programming – Q1 2025

Project Scope:

What features are most beneficial to stat programming? What are the benefits of Git?

There is interest across the pharmaceutical industry in using Git for statistical programming. Some companies have already incorporated Git, or are attempting to, and there are common challenges being faced. In these cases, the introduction of Git has increased the complexity of a statistical programmer’s tasks, which has led to challenges in uptake and to taking advantage of the benefits Git offers. This is an important challenge to overcome for increasing efficiency of operations. The purpose of this Working Group project is to provide the industry with tools and guidance for addressing and overcoming this common challenge.

Current Status:

  • Project Approved

  • Project Calling For Volunteers

Regular Project Meeting Day/Time:

  • Kick-Off Meeting: 4 April 2025

Key Skills: (currently being reviewed by WG Leads)