APR May/June 2023 - 43

« FORMULATION AND DEVELOPMENT
Figure 1. The DCT spectrum
To meet the needs of this new approach, specialized data management
and digital and decentralized solutions teams have continued to
expand to support sponsors through functional service provider (FSP)
sourcing models. With this expertise, sponsors get access to the knowhow
they need to evaluate four key decision points made early in the
development life cycle that are critical to the success of a DCT strategy.
They involve choosing the right:
1. Outsourcing model
2. Patient experience
3.
Site experience
4. Data journey
Making those right decisions-while understanding the tradeoffs
involved in each-translates to a more consistent and quality
experience both for patients and sites, a study that is delivered on
schedule, and assurance of data integrity and reliability of studies.
Decision Point #1: Selecting the
Right Outsourcing Model
DCTs offer the potential for transformative benefits to the clinical
research industry, including faster and more efficient trials and
enhanced patient experiences. However, when designing a DCT
trial, sponsors must navigate multiple types of approaches and
technologies while also balancing the different needs of a range
of stakeholders.
To minimize the risk of issues and disruptions, DCTs must be designed
with the end in mind. This means that from the pre-protocol design
stage, DCT and data management experts are needed with the
experience and expertise to critically think through the full ecosystem
to evaluate potential implications of decisions. To this end,
essential to engage partners at the earliest stages to embed the
it
is
necessary subject matter expertise. Ideally, a partner should have the
experience and expertise to help drive the overall DCT strategy design
and implementation plan and - understanding that data management
is one of the critical underpinnings of the overall success of a DCT -
should assist in driving an integrated data management plan.
When outsourcing the implementation of DCTs, there are several
options. Full-service models offer end-to-end clinical development
services across a trial, while FSP models involve the outsourcing of
some or all of one or more functions, potentially across a portfolio. And
finally, there are hybrids of both models.
In our experience, the FSP approach is often an ideal model for
DCTs. Every DCT is unique, and the FSP model offers the flexibility to
complement a sponsor's existing capabilities with dedicated functional
expertise in targeted areas critical to DCTs. An FSP, for example, could
be designed to deliver an end-to-end data management solution
that encompasses all needed expertise, services, technologies, and
processes. Or the FSP solution could incorporate a blend of sponsor,
CRO and vendor tools, technologies, and processes. The strength of
the FSP model is that it delivers the flexibility to meet the specific
needs of a DCT while also embracing the rapidly changing evolution
of our industry (e.g., by adopting a vendor's new wearables/data
collection device or incorporating artificial intelligence and machine
learning technologies like robotics process engineering to automate
repetitive tasks.)
Additionally, in cases where a sponsor is implementing multiple DCTs
across a portfolio, an FSP model is capable of scaling to incorporate
DCT capabilities and best practices consistently across all trials in the
sponsor's portfolio instead of on a limited trial-by-trial basis.
FSP models also enable engagement with functional subject matter
experts who provide the right expertise at the right moment, including
operational, clinical, and regulatory experience, to help guide the
strategy, identify and mitigate risks, and drive accountability. These
experts provide on-demand knowledge and consultation, as needed,
around how to incorporate best practices, country-specific parameters
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APR May/June 2023

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