Media · Speaking · Press

Invite Lauren for a clinical systems governance perspective.

Podcast appearances, conference keynotes, panels, press interviews. Clinical data integrity, sponsor accountability, vendor governance, and the regulatory shift sponsors are navigating under ICH GCP E6(R3), EMA guidelines, and FDA 21 CFR Part 11.

Lauren Alani at ACDM Symposium 2023, presenting on decentralized clinical trials

The data behind Lauren’s keynotes

  • EMA 2023 inspections · computer systems generated 46 findings (5 critical, 22 major); sponsors received the highest number of critical findings in three top areas
  • FDA inspections 2018-2024 · 138 of 194 domestic drug manufacturing inspections produced findings; data integrity issues in 81 of those 138
  • ACRP site survey 2024 · 19% of ~850 sites cited sponsor-provided technology as a top operational challenge
  • ICH GCP E6(R3) · raised sponsor oversight expectations on computerised systems, validation, and service-provider qualification
Why invite Lauren

Sponsor-side, regulator-credible, and prepared.

What hosts, conference programmers, and journalists tend to say about putting Lauren on their stage, panel, or show.

01

Sponsor-side, not vendor-side

Lauren writes and speaks from the sponsor’s accountability seat. The perspective is independent of CRO delivery and independent of vendor commercial interest. Useful for audiences who want clarity on who actually owns clinical data integrity, and who is exposed when it falters.

02

Regulatory grounding, not regulatory rehearsal

Every perspective is anchored in ICH GCP E6(R3), EMA guidelines, FDA 21 CFR Part 11, and ALCOA+ principles. Lauren chaired the ACDM eDigital Data Management Expert Group for five years and co-authored four ACDM industry whitepapers. The references are operational, not theoretical.

03

Prepared, not performative

Lauren prepares with the host or organiser before the recording or the keynote. She arrives with specific, publishable insight, never with quotable hot takes. Her diplomatic questioning method exposes assumptions without combativeness; it does not score points.

Speaking topics

Four core topics I take to stages, panels, and microphones.

Roadshow format
Two core talks · 2026
i.

Accountability Cannot Be Delegated

Why the MSA does not transfer regulatory accountability, and what evidence sponsors need at inspection.

Read more
ii.

The Regulator-Vendor Gap

The structural gap between regulator expectations and vendor accountability, and how sponsors close it.

Read more
iii.

Requirements Before Selection

Why selecting clinical technology before defining trial-level requirements is a procurement risk.

Read more
iv.

Data Integrity Is a Commercial Risk

Reframing data integrity from regulatory hygiene to enterprise risk, with examples from sponsor-side practice.

Read more
Quotable Lauren

Lines from her writing, ready for press, podcast notes, and panel briefings.

The sponsor signed the protocol. The sponsor owns the data. No master service agreement transfers that.
Foundational perspective · The Ecosystem View
You can delegate tasks. You cannot delegate responsibility.
i. · Accountability Cannot Be Delegated
Regulators set expectations vendors are not directly accountable for. Sponsors absorb the gap by default.
ii. · The Regulator-Vendor Gap
Define trial-level requirements before selecting clinical technology. Selection without specification is a procurement risk.
iii. · Requirements Before Selection
Data integrity is not regulatory hygiene. It is enterprise risk that touches asset valuation directly.
iv. · Data Integrity Is a Commercial Risk
Innovation is welcome. Only when it is validated.
Lauren’s operating principle
Lauren Alani delivering a keynote at an industry conference, large screen behind showing the Seuss+ digital innovation framework
Recent stage Lauren delivering on the digital innovation framework at Digital Health World Congress.
Recent appearances

Podcasts, panels, conferences, regulatory roundtables.

Speaking on Stage
: Arkivum — ArkFest 2025 (free virtual conference for digital archiving and preservation in pharma, higher education, and cultural heritage)

ArkFest 2025 — Lauren Alani (Seuss+) named speaker

ArkFest 2025 is Arkivum's free, online digital-archiving-and-preservation conference (15–17 July 2025) for professionals in pharma, higher education, and cultural heritage. Lauren appears on the speakers…

Webinar
DiMe Webinar

DiMe Webinar

Showcasing Biotech Success Stories: Digital Endpoints in Clinical Trials

Request a booking

Podcast, keynote, panel, press interview.

Tell me the topic, audience, and timing. If we are a fit, my team will reply within two business days. If not, my team will say so directly. Reflective conversations beat rushed ones.

Bookings managed by: Gina Dunn, Director of Marketing at Seuss+.

Topics in scope: clinical systems governance, sponsor accountability, data integrity, vendor oversight, computerised system validation, the regulatory shift under ICH GCP E6(R3), EMA, FDA 21 CFR Part 11.

Out of scope: AI implementation specifics, IT infrastructure standards, individual vendor critique. (Stated authority boundaries.)

Booking FAQ

Practical questions before you reach out.

How far in advance should I book Lauren?+

Podcasts: typically 3 to 4 weeks lead time. Conference keynotes and panels: 8 to 12 weeks ideally, longer for headline slots. Press interviews on topical stories are often faster turnaround. Roundtables and webinars sit between the two. Lauren is currently accepting Q2 2026 speaking; ARKFest 2026 is a confirmed return engagement.

Does Lauren charge a speaking fee?+

Fees depend on event type, audience, format, and whether the programming is sponsored. Some engagements are unpaid when the audience fit is strong (academic, regulatory, or peer-association events, for example). Industry events with vendor sponsorship typically include a fee. Include budget context in your request and Gina Dunn will reply with whether the fit is right.

What topics will Lauren NOT speak to?+

Lauren has stated authority boundaries. Out of scope: AI implementation specifics or technical AI advice; deep IT infrastructure standards; individual vendor critique or named-vendor commentary; medical advice, clinical recommendations, or patient-level guidance; forward-looking statements about specific assets, products, or indications; interpretation of unpublished or confidential clinical data; vendor rankings or competitive CRO comparisons.

Can Lauren travel for speaking engagements?+

Yes. Lauren is UK-based and travels internationally for industry events, regulatory roundtables, and sponsor-side advisory days. Remote and virtual appearances are supported and often preferred for podcasts and panel discussions.

What formats does Lauren engage in?+

Conference keynotes (preferred 30 to 45 minute slots), panel chairs and panellist roles, podcast guest interviews (60 to 90 minute long-form preferred over 20 minute soundbite formats), regulatory roundtables and closed-door advisory sessions, press interviews and bylined commentary, sponsor-side workshops on clinical systems oversight and inspection readiness.

Will Lauren reference specific sponsors or clients on stage?+

No. Sponsor engagements are confidential by default. Examples Lauren uses on stage and in press are generalised structural patterns drawn from years of sponsor-side observation, never case studies of specific clients. Where regulatory references are made (ICH GCP E6(R3), EMA, FDA 21 CFR Part 11, ALCOA+), readers and audiences are encouraged to consult the primary source for authoritative content.

Media contact

Gina Dunn

Director of Marketing · Seuss+

For press enquiries, podcast bookings, speaking invitations, and interview requests on Lauren’s behalf. Responses within two business days.

g.dunn@consultseuss.com

Lauren does not handle outbound bookings directly. Send everything to Gina; it will reach Lauren if it should.