Emerging Trends & Innovation – Project Volunteer Board

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

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:

• N/A

Key Skills:

• Experience with the use of DHTs

• Experience with AI/ML

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 ???

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 Cases