Emerging Trends & Innovation – Project Volunteer Board

Interested in joining one of the Emerging Trends & Innovation Working Group Projects? The projects below welcome new volunteers.

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.

Regular Project Meeting Day/Time:

• Biweekly: Wednesdays 16:00-17:00 BST

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

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.

Regular Project Meeting Day/Time:

• Bi-Weekly: Tuesday 15:00-16:00 BST

Key Skills:

• Bioinformatics knowledge

• Regulatory submission understanding

   

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.

Regular Project Meeting Day/Time:

• Bi-Weekly: Friday 15:00-16:00 BST

Key Skills:

• Experience with Git platforms

• Statistical programming knowledge

Project Scope:

The scope will include the following topics:

• 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?

Regular Project Meeting Day/Time:

• Monthly: Wednesday 13:00-14:00 BST

Key Skills:

• Understanding of QC and validation processes 

• Awareness of AI and automation tools