Brief · Use case · Pharmacovigilance

Pharmacovigilance Technology Landscape.

LiveLandscape

Give the board a view of pharmacovigilance technology vendors: market size by source, who plays where and what it means for a system decision.

MarketPharmacovigilance technology for case processing and signal detection

ReaderA safety department replacing its systems

ExpertHead of Pharmacovigilance

Not askedA ranking of vendors

LengthStandard

Pharmacovigilance Technology Landscape is a ready-made use case for Pharmacovigilance. It ships under the Landscape template.

For pharmacovigilance leads. You get the picture in brief, the boundary and inclusion rule, size estimates side by side, vendors by function and what it means for the replacement. Figures 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

What is the landscape of pharmacovigilance technology vendors for case processing and signal detection, for a safety department replacing its systems?

What is mapped

A safety system has to exchange cases with regulators in a defined format and support a defined process. The landscape uses those standards as its inclusion rule.

Segment or source	What it holds	What the landscape does with it
Case exchange standard	ICH E2B(R3) is the standard for electronic transmission of individual case safety reports, with EU-specific rules layered on top for EudraVigilance and a separate regional guide for FDA.^{1European Medicines Agency. ICH E2B(R3) Electronic transmission of individual case safety reports (ICSRs): data elements and message specification, implementation guide. EMA/CHMP/ICH/287/1995; legal effective date 1 July 2013.}	The ICH implementation guide, EMA’s EU guide and FDA’s technical specifications.
Signal management process	The EU signal management requirements and guidance in GVP Module IX, revision 1, with statistical aspects in an addendum.^{2European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}	EMA’s good pharmacovigilance practices.
Detection methods	The statistical methods the systems implement, such as the proportional reporting ratio and the empirical Bayes geometric mean, each with published criteria.^{3Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.,4DuMouchel, W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. The American Statistician, 1999;53(3):177–190.}	The original papers on each method.

What the landscape does

Standards make the boundary checkable. The landscape includes a vendor only if its product supports E2B(R3) transmission for the regions the department reports to, and if it supports the signal management steps in Module IX. It says how it checked, and counts the vendors that could not be confirmed.^{1European Medicines Agency. ICH E2B(R3) Electronic transmission of individual case safety reports (ICSRs): data elements and message specification, implementation guide. EMA/CHMP/ICH/287/1995; legal effective date 1 July 2013.,2European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

A regional layer. The ICH standard has regional rules. EMA’s EU implementation guide adds EU requirements for terminology, and FDA has its own technical specifications for drug and biological products. The landscape records which regions each vendor supports.^{1European Medicines Agency. ICH E2B(R3) Electronic transmission of individual case safety reports (ICSRs): data elements and message specification, implementation guide. EMA/CHMP/ICH/287/1995; legal effective date 1 July 2013.}

Methods have published criteria. The proportional reporting ratio was proposed with criteria of three or more cases, a ratio of at least 2 and a chi-squared of at least 4. The empirical Bayes method was designed for tables in which most cells hold few reports. The landscape notes which methods each product implements and which thresholds it uses.^{3Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.,4DuMouchel, W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. The American Statistician, 1999;53(3):177–190.}

Replacing a system is a project. The landscape lists what the department would have to migrate and validate, and marks which of these a vendor states it supports.

Recommended length

Standard

The market has a clear boundary and a short list of players. Standard carries the picture, the boundary, the numbers, the players and what it means in about 1,500 words.

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

Assumptions the landscape checks

The landscape states the assumptions its boundary and its sizes rest on, and says what each gap limits. Examples for this market:

A vendor’s statement that it supports E2B(R3) holds for the version and region the department needs.
The department’s signal process is the one Module IX describes.
The systems can be validated within the department’s timeline.

Standards, guidance and sources

Standards

ICH E2B(R3), electronic transmission of individual case safety reports, with the EU and FDA regional guides.^{1European Medicines Agency. ICH E2B(R3) Electronic transmission of individual case safety reports (ICSRs): data elements and message specification, implementation guide. EMA/CHMP/ICH/287/1995; legal effective date 1 July 2013.}
EMA, GVP Module IX: Signal management (Rev. 1), in effect from 22 November 2017.^{2European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

Methods

Evans, Waller and Davis, proportional reporting ratios, 2001.^{3Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}
DuMouchel, Bayesian data mining in large frequency tables, 1999.^{4DuMouchel, W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. The American Statistician, 1999;53(3):177–190.}

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

What gets flagged

Any vendor included on its own statement of standards support, any region the landscape could not confirm, and any method whose threshold a vendor does not publish.

What arrives

The picture in brief
Scope and boundary
The market in numbers
Who plays where
What is shaping it
What it means for us
What we could not source

What it will not do

It does not rank players or give a single market size. It shows estimates side by side with their sources, and a position on a map is labeled analyst judgment.

It is not a system validation and does not recommend a vendor.

It does not give a single market size when the sources disagree. It shows each estimate and says why they differ.

It does not rank players. A map places them on defined axes and labels the placement as judgment.

It is a snapshot of one date, from public sources. A player it could not find is listed as a gap.

References

[1] European Medicines Agency. ICH E2B(R3) Electronic transmission of individual case safety reports (ICSRs): data elements and message specification, implementation guide. EMA/CHMP/ICH/287/1995; legal effective date 1 July 2013. Known from EMA’s page listing and search excerpts; the guide was not read. The EU and FDA regional guides are separate documents.
[2] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017. Status and scope as given in EMA’s listing found by search; the module was not read in full.
[3] Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486. Read from the abstract as summarized in search excerpts.
[4] DuMouchel, W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. The American Statistician, 1999;53(3):177–190. Abstract only.

Links checked 9 October 2026

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

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