Changing the Norm

Decentralized Clinical Research Frameworks and Playbooks

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How Do You "Change the Norm"?

Our goal is to facilitate and support the transformation of clinical trial teams as they adopt decentralized clinical trial (DCT) and/or hybrid models. This includes identifying barriers and pain points, enabling and assisting project teams in adopting a hybrid or full-DCT format, and minimizing the burden on sites as the industry landscape shifts. A framework containing a strategy, methodology, standardized templates, checklists, and communication guidelines will be developed. Effective change management, stakeholder engagement, and knowledge transfer are crucial for successful implementation of any new method.

The team is divided into four working groups to address these challenges:

●    Data and Quality Technology
●    Operations
●    Implementation
●    Regulatory and Data Privacy 

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Our Approach

Our approach addresses several challenges that sites face as they adopt DCT and hybrid models. These challenges include:

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Overwhelmed Sites 

Sites are struggling with multiple studies requiring different technologies and multiple logins. We will provide guidance on how to streamline processes and manage resources effectively.

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Operational Changes 

We will help sites understand how adopting DCT impacts their operating model, including costs, material transfers, and interactions with sponsors, patients, and healthcare professionals.

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DCT Perception Issues 

We will address misconceptions about DCT and hybrid models (e.g., reduced revenue) to foster trust and facilitate adoption.

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Inefficiencies and Pain Points 

We will identify and address inefficiencies in site operations and work to improve interactions with remote resources like contractors.

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Regulatory Concerns 

We will offer guidance on compliance with regulations such as HIPAA.

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Cross-State or Cross-Geography Challenges 

We will provide guidance on how to manage operations across states/geographies.

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Deliverables

The creation of a Decentralized Research Readiness Framework considerate of change management best practices globally for stakeholders (especially sponsors, CROs, and sites).

Download the 
Full Initiative Charter

Relevant Resources