Panel · Use case · Medical Affairs

Manuscript and Abstract Review.

LiveDocument Review

Does this real-world evidence manuscript report what it should and claim no more than the data allow?

DocumentA real-world evidence manuscript

LanesMedical, real-world evidence, HEOR, compliance

ReaderMedical and evidence leads

Not askedA rewrite

DepthStandard, four seats

Manuscript and Abstract Review is a ready-made use case for Medical Affairs. It ships under the Document Review template.

For medical affairs leads. You get an item-by-item ledger with verdicts and risk, the substantiation each claim needs, the required changes and what the review could not check. Claims are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

Does this real-world evidence manuscript report what it should and claim no more than the data allow?

Who reviews

Observational studies are reported to STROBE, and studies that use routinely collected data to RECORD. The seats review against both.

Seat	What it reviews	What it works from
Global Medical Affairs Director	Whether the conclusions follow from the results and fit the clinical context.	The manuscript and the literature.
Global Real-World Evidence Lead	Design, data source, bias and confounding, and reporting.^{1von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. 2007.,2Benchimol, E. I. et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Medicine, 2015;12(10):e1001885.}	STROBE and RECORD.
HEOR Evidence Lead	Whether outcomes and costs are measured and described correctly.	Health economics methods.
Global Commercial Compliance Officer	Whether authorship, funding and disclosure meet policy, and whether the paper reads as promotion.	Publication policy.

What the review does

Claims no stronger than the design. Observational data show association. The ledger marks causal language that the design does not support and states the change.^{1von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. 2007.}

Reporting items. The review lists the STROBE and RECORD items that are missing, for example how the data were selected and how missing data were handled.^{1von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. 2007.,2Benchimol, E. I. et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Medicine, 2015;12(10):e1001885.}

Funding and disclosure. The compliance seat checks that sponsorship and the role of the company are stated.

Recommended length

Standard

Four lanes bear on this document. Standard depth gives each a seat, the ledger and the substantiation table in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the review makes

The review states what it assumes about the document and the material supplied, and says what each gap limits. Examples for this document:

The manuscript is the current version.
The analysis plan was specified before the analysis.
The data source is described fully in the methods.

Standards, guidance and sources

Framework

STROBE statement for reporting observational studies.^{1von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. 2007.}
RECORD statement for studies using routinely collected health data.^{2Benchimol, E. I. et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Medicine, 2015;12(10):e1001885.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any causal claim from an observational design, any reporting item missing, and any undisclosed company role.

What arrives

The document under review
Overall recommendation
The review, by seat
Item-by-item ledger
Substantiation and evidence gaps
Required changes and conditions for approval
Rebuttal round
What this review could not check

What it will not do

This is analyst judgment from AI specialists and not a regulatory, medical or legal sign-off. It cannot check original data or the approved label, and the decision stays with you.

It is not peer review for a journal.

It is analyst judgment from AI specialists and not a regulatory, medical or legal sign-off.

It does not rewrite the document. It states the change and leaves the writing to the author.

It does not check original data or the approved label held by the company. Those checks need a real reviewer.

References

[1] von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. 2007. Known by citation and the EQUATOR listing; not read in full.
[2] Benchimol, E. I. et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Medicine, 2015;12(10):e1001885. Known by citation and the EQUATOR listing; not read in full.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

To edit a saved template, open New → Panel → From template, or the library rail on the service form.