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BEGIN:VEVENT
UID:20260702T230058Z - 75788@5dac2d9de651
DTSTART;TZID=Europe/Brussels:20260723T160000
DTEND;TZID=Europe/Brussels:20260723T173000
CREATED:20260702T230058Z
DESCRIPTION:SCDM Webinar | \nSCDM Webinar Closing the RBQM Adoption Gap: An A
I-Guided Action Path from Risk Signals to Supervised Execution Description
: "Clinical development does not lack visibility into operational risk. Ri
sk-Based Quality Management has given study teams more dashboards\, key ri
sk indicators\, and central monitoring signals than at any point in the in
dustry’s history. What remains constrained is the capacity to translate
those signals into timely\, coordinated\, and documented action across fun
ctions and systems. This constraint is now a regulatory one. ICH E6(R3) Pr
inciples and Annex 1 reached final adoption in January 2025\, became effec
tive across the EU on July 23\, 2025\, and were published by the FDA in Se
ptember 2025\, with the MHRA and Health Canada following. RBQM is no longe
r encouraged practice - it is the operating model regulators expect across
the trial lifecycle. Yet adoption remains uneven\, and the gap sits preci
sely where it matters most. Industry research from the Tufts Center for th
e Study of Drug Development\, conducted with CluePoints and PwC across 206
respondents and 32 distinct RBQM components\, found that organizations im
plement RBQM in 57% of clinical trials on average. Adoption is highest in
documentation and resolution at 60% and lowest in execution at 52%. Smalle
r sponsors running fewer than 25 trials a year sit at 48%\, against 63% at
organizations running more than 100. The barriers identified are organiza
tional rather than technical: limited cross-functional knowledge and aware
ness\, mixed perceptions of the value proposition\, and weak change manage
ment in planning and execution. This is the RBQM adoption gap - the distan
ce between regulatory expectation\, demonstrated value\, and what study te
ams can consistently operationalize. Clinical data professionals sit at it
s center. They surface the signals and document the decisions\, but much o
f the [...]
DTSTAMP:20260702T230058Z
SUMMARY:SCDM Webinar |
X-ALT-DESC;FMTTYPE=text/html:SCDM Webinar | \nSCDM Webinar Closing the RBQM A
doption Gap: An AI-Guided Action Path from Risk Signals to Supervised Exec
ution Description: "Clinical development does not lack visibility into ope
rational risk. Risk-Based Quality Management has given study teams more da
shboards\, key risk indicators\, and central monitoring signals than at an
y point in the industry’s history. What remains constrained is the capac
ity to translate those signals into timely\, coordinated\, and documented
action across functions and systems. This constraint is now a regulatory o
ne. ICH E6(R3) Principles and Annex 1 reached final adoption in January 20
25\, became effective across the EU on July 23\, 2025\, and were published
by the FDA in September 2025\, with the MHRA and Health Canada following.
RBQM is no longer encouraged practice - it is the operating model regulat
ors expect across the trial lifecycle. Yet adoption remains uneven\, and t
he gap sits precisely where it matters most. Industry research from the Tu
fts Center for the Study of Drug Development\, conducted with CluePoints a
nd PwC across 206 respondents and 32 distinct RBQM components\, found that
organizations implement RBQM in 57% of clinical trials on average. Adopti
on is highest in documentation and resolution at 60% and lowest in executi
on at 52%. Smaller sponsors running fewer than 25 trials a year sit at 48%
\, against 63% at organizations running more than 100. The barriers identi
fied are organizational rather than technical: limited cross-functional kn
owledge and awareness\, mixed perceptions of the value proposition\, and w
eak change management in planning and execution. This is the RBQM adoption
gap - the distance between regulatory expectation\, demonstrated value\,
and what study teams can consistently operationalize. Clinical data profes
sionals sit at its center. They surface the signals and document the decis
ions\, but much of the [...]
END:VEVENT
END:VCALENDAR