August 2024 SOCRA Source Journal - Journal - Page 23
Using the cloud to store data,
not an individual’s computer,
makes data discoverable.
Computers can be lost or
stolen. Storing data in the cloud
makes it available on mobile
devices as well as computers,
and securely accessible.
The next consideration is
the ability to 昀椀nd data by
searching for it. Search and
昀椀lter capabilities are critical.
Important data points should
not be buried 5 or 10 clicks
away. They should be accessible
with one click. Research
team collaboration and risk
management includes being
able to track changes across the
research team and being able
to visualize those changes.
We feel that the chasm between
pharmaceutical companies and
clinical research sites continues
to grow. Technology solutions
should start to build a bridge
between pharmaceutical
companies and clinical research
sites. This should include having
meaningful conversations about
Application Programming
Interface (API) integration and
data exchange or feedback.
This will enable everyone to
make smarter, more actionable
decisions moving forward.
When considering investment,
most people think of 昀椀nancial
investment and the bottom
line. Investment is also time. If
the research team is currently
doing tasks that add two or
three hours to each day, this is
harmful for morale and affects
staff retention. Staff time is
not being used wisely. When
assessing paid or free solutions,
the required investment in
time as well as money must be
considered.
The second example focuses
on the business development
team and the feasibility
questionnaire work昀氀ow. The
business development team
receives an email from a
sponsor about a new study
and needs to complete the
feasibility questionnaire. This
feasibility questionnaire looks
very similar to the one the team
completed the day before. The
team member starts to type
in redundant information from
previous questionnaires. That
information lives in the head
of the team member who is
completing the questionnaire.
This is not scalable, as other
team members may not have
access to the information.
Also, in a large clinical research
site, three or four members of
the business development team
may be completing feasibility
questionnaires. Their answers
should be consistent.
Data has a single source of
truth and data is discoverable,
clinical research sites have
developed innovative solutions
to try to solve this problem.
These solutions include taking
screenshots of every page in the
feasibility questionnaire before
submission and storing them
in an archive. Some sites copy
and paste answers into Word
documents or Excel 昀椀les. This is
a step forward, however, these
are dif昀椀cult to maintain and to
ensure that different members
of the business development
team are doing this consistently.
Also, discovering the data is
somewhat dif昀椀cult.
Lightweight solutions that can
be used along with the clinical
research site’s current solution
include browser extensions.
Browser extensions make it very
easy to add an experience on
top of existing websites and
webpages. They are a great way
to build consistent experiences
across solutions.
A better experience for
completing feasibility
questionnaires could be
embedded in a browser
extension. For example,
a member of the business
development team could
choose which site they are
completing the feasibility
questionnaire for. As they type,
their answers are autosaved.
The answers are saved to a
database that is searchable and
reusable.
Embedding feasibility
questionnaires in a browser
extension also facilitates team
collaboration. If the member
of the business development
team does not know the
answer to a question, they
can assign the question to the
clinical investigator or a study
coordinator.
Conclusion and Key Takeaways
There are good reasons to be
optimistic for the future about
developing effective technology
solutions for clinical research.
Everyone who is involved
in clinical research has used
technology that is not ideal,
does not work, or creates pain.
Technology can be problematic.
Technology is not a magic bullet
that solves all clinical research
problems.
SOCRA SOURCE © May 2024
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