Pharmaceuticals
Competitive intelligence that survives the committee's only question.
Competitive intelligence that survives the question a portfolio committee always asks: where did that come from, and when.
the worked caseA pipeline page, a registry record and a February deck name three different lead programs. The record carries one, dated, and shows the two it was chosen over.

Two worked cases on this page, both fictional and both built the way a real one is: a value, the document it was read from, the date of reading, and the value it was chosen over.
The questions you get asked
Nobody asks for more information. They ask whether one line can be defended.
These are the questions that arrive after the work is delivered, from the party entitled to disagree with it. Every property on this page exists because one of them has to have an answer that does not depend on the person who assembled the file.
- 01
Where did that phase number come from, and when was it read?
- 02
Is that readout date something the company has said, or a registry estimate of something else?
- 03
This contradicts the brief we saw in February. What changed, the world or the file?
- 04
If their pipeline page is edited tomorrow, does our position change without anyone deciding to change it?
Asked by a portfolio committee, by the counterparty in a licensing negotiation, and in time by whoever audits the decision they led to.
The buyer
Competitive intelligence, business development and portfolio strategy
The people who assemble the company, program and trial picture that an investment committee, a licensing negotiation or a launch plan is built on, and who are asked to defend a single line of it six months later.
What they fuse
Three kinds of source, one answer
Each kind arrives with different licence terms, different reader restrictions and different reasons to be wrong. The record keeps them distinguishable after the fusion, which is the part that is normally lost.
Deal-room documents, expert-network notes, and memoranda that exist nowhere else and cannot leave the building.
Pipeline and epidemiology subscriptions whose terms restrict who inside the organization may read them.
ClinicalTrials.gov and CTIS records with their version history, securities filings, regulatory correspondence, conference abstracts and company pipeline pages.
Worked case one
Sources that disagreeOne company, three published development phases
A registry record, a January press release and an unrevised pipeline page described the same study differently. Nothing here is resolved by preferring the newest document: the record carries the value it can cite, names the two it was chosen over, and keeps the readout date as a declared unknown rather than borrowing the registry's estimated primary completion, which is a different quantity.
The figure beside this is what the reader sees: the value, its status, the source it was read from, and the value it was chosen over.
Worked case two
A source nobody has re-readA figure that is true of a document nobody has opened since August
The enrolment figure in the brief was read from registry version 6 in August, and the registry has since posted five further versions. Neither silent refresh nor silent staleness is acceptable: the value keeps the version and the date it was actually observed, the current figure is declared unread until somebody reads it, and the age of an observation is a property on the face of the record rather than something the reader has to work out.
A different failure from the first case, on the same record and under the same four guarantees. Both are fictional; neither is a simplification of how the values are shown.
Why the record has to hold
What the rules ask for, in their own words
These are the recordkeeping obligations that make a defensible value a requirement rather than a preference. We name them because our customers are measured against them; we make no claim to certify anyone against any of them.
Electronic records and electronic signatures
United StatesRecords relied on in a regulated decision must be attributable to a source, retrievable through their retention period, and accompanied by a secure, computer-generated record of changes.
Computerised systems in GxP activities
European UnionSystems must keep a record of changes from which the reason for the change can be reconstructed, and data must remain readable through its retention period.
Traceability of clinical data
ICH, adopted by FDA, EMA and PMDAA reported result must be traceable back to its source data, and the source itself must be preserved and available for inspection.
What changes for this reader
The same work, with the evidence attached at the moment it is read
Not a claim about speed and not a claim about savings: a description of the practice on each side. Everything on the left is what people in this role do today, and almost all of it is done well by people who resent having to do it that way.
The competitor tracker has a source column holding a link and, where somebody was careful, the month it was opened.
Every cell carries the registry version or the slide it was read from and the date of reading, so the source column stops being a promise.
When a registry record and a press release disagree about a phase, the analyst takes the newer one and the reasoning stays in their head.
The briefed value names the value it was chosen over, so the committee sees the alternative instead of being asked to assume there was not one.
A program with no published readout date reaches the deck as a blank cell, or as an estimated primary completion date quietly relabelled.
It reaches the deck as not found, with the sources searched and the date, and a primary completion estimate is never printed as a readout.
A number read from a registry last summer sits in the deck with nothing to say how old the reading is.
The value shows the version and the date it was observed, and a later version of the source is visible as unread rather than assumed to agree.
Material from a subscription the team may not circulate is either used without attribution or dropped without trace.
It is labelled blocked and named, so the person who can authorise the licence can see what the brief is missing.
What you get
What the record guarantees pharma readers
The four guarantees, stated in the vocabulary of this sector. They are the same four everywhere; read them in general on the guarantees page, and see them applied to a live record on the demonstration.
- One record per company and per program, kept apart from its namesakes and from its former names.
- A registry version number, a page or an address, and a retrieval date behind every value you brief.
- A readout, an enrolment figure or a partner that has not been published is declared not found, with the list of what was searched and when.
- The brief you sent to a committee in March can be reproduced in September exactly as it stood.
Primary sources
The texts behind these obligations
The three obligations above come from published texts. They are listed here so that a reader can open each one and check that it asks for what we say it asks for. None of them certifies a system, and none is a statement that any record satisfies it.
- 21 CFR 11.10, Controls for closed systems (FDA). Secure, computer-generated, time-stamped audit trails that do not obscure previously recorded information.
- FDA guidance, Part 11 Electronic Records; Electronic Signatures: Scope and Application. How the agency describes its approach to applying Part 11.
- EudraLex Volume 4, including Annex 11 Computerised Systems (European Commission). The European good manufacturing practice guidelines and their annexes.
- ICH E6(R3) Good Clinical Practice, Step 4 final guideline. Source data, records and traceability in clinical trials.
Reference pages that apply to this sector
- ClinicalTrials.gov identifier (NCT number)
- Unique Ingredient Identifier (UNII)
- National Drug Code (NDC)
- Anatomical Therapeutic Chemical (ATC) classification
- Digital Object Identifier (DOI)
- Citing at the sentence
- Retaining source copies
- Reproducing a past state
- Snapshots vs bitemporal history