Systems and methods for electronically monitoring expected adverse reactions of pharmaceutical products

1 . A method for determining and indicating expectedness of an adverse event in an expectedness monitoring and analyzation system, wherein the expectedness monitoring and analyzation system comprises a provider computing system and a user computing device communicating with each other via a network, and wherein the provider computing system comprises a document repository for storing electronic reference documents, the method comprising:

receiving, by a network interface of the provider computing system, adverse event data including a first medical dictionary for regulatory activities (MedDRA) code associated with the adverse event and a clinical study;

determining, by a processing circuit of the provider computing system, an electronic reference document associated with the clinical study;

selecting, by the processing circuit, the electronic reference document including a defined adverse reaction from the document repository, wherein the defined adverse reaction includes an active start date, a second MedDRA code, and a seriousness exclusion, and

wherein the document repository enforces a system-wide single data source policy by maintaining a single version of the electronic reference document for the clinical study;

generating, by the processing circuit, a case dataset including at least a portion of the adverse event data;

determining, by the processing circuit, the expectedness of the adverse event based on the defined adverse reaction of the electronic reference document and the adverse event data;

determining, by the processing circuit, a first submission address associated with a first health agency,

wherein the first health agency is the Food and Drug Agency (FDA), and wherein the first submission address is an address associated with the Electronics Submission Gateway (ESG) of the FDA;

determining, the processing circuit, a second submission address associated with a second health agency;

determining, by the processing circuit, a first submission timeframe associated with the case dataset based on the expectedness of the adverse event and the first submission address;

determining, by the processing circuit, a second submission timeframe associated with the case dataset based on the expectedness of the adverse event and the second submission address,

determining, by the processing circuit, a first submission comprising an E2B XML file type and the first submission address based on the adverse event data; and

outputting, by AS2 gateway logic of the network interface, the case dataset as the E2B XML file type to the first submission address based on the first submission.

2 . The method of claim 1 ,

wherein the case dataset is output within the first submission timeframe.

3 . The method of claim 1 , further comprising:

determining, by the processing circuit, a second submission comprising a second file type and the second submission address based on the adverse event data;

and

outputting, by the network interface, the case dataset as the second file type to the second submission address based on the second submission.

4 . The method of claim 1 , wherein the adverse event data includes seriousness data, and wherein the first submission timeframe is determined based on the expectedness of the adverse event, the first submission address, and the seriousness data.

5 . The method of claim 1 , wherein determining the expectedness of the adverse event comprises:

determining, by the processing circuit, the first MedDRA code of the adverse event matches the second MedDRA code of the defined adverse reaction; and

determining, in response to the date data being after the active start date of the defined adverse reaction and by the processing circuit, the adverse event is unexpected.

6 . The method of claim 1 , wherein the seriousness exclusion identifies a seriousness of the adverse event for which the adverse event is expected or unexpected.

7 . The method of claim 1 , wherein the adverse event data includes seriousness data and date data, and wherein determining the expectedness for the adverse event comprises:

determining, in response to the date data being after the active start date of the defined adverse reaction and by the processing circuit, the seriousness exclusion of the electronic reference document at least partially matches the seriousness data; and

determining, by the processing circuit, the adverse event is unexpected based on the seriousness exclusion at least partially matching the seriousness data.

8 . The method of claim 1 , further comprising:

indicating, by the processing circuit, the expectedness of the adverse event in the case dataset; and

providing, by the network interface, at least a portion of the case dataset to the user computing device to enable display on a user interface, wherein the user interface includes an expectedness section including the indication of the expectedness of the adverse event.

9 . The method of claim 1 , further comprising:

providing, by the network interface, at least a portion of the electronic reference document to the user computing device to enable display on a user interface, wherein the user interface includes a defined adverse reactions section;

receiving, by the network interface, the defined adverse reaction from the user computing device including the active start date, wherein the defined adverse reaction is received via the defined adverse reactions section of the user interface; and

storing, by the document repository, the defined adverse reaction in association with the electronic reference document.

10 . The method of claim 9 , wherein the user interface includes a seriousness exclusion drop-down box, and further comprising:

receiving, by the network interface, the seriousness exclusion from the user computing device, wherein the seriousness exclusion is received via the seriousness exclusion drop-down box of the user interface; and

storing, by the document repository, the seriousness exclusion in association with the electronic reference document.

11 . A method for determining and indicating expectedness of a first adverse event and a second adverse event in an expectedness monitoring and analyzation system, wherein the expectedness monitoring and analyzation system comprises a provider computing system including a document repository for storing electronic reference documents, the method comprising:

receiving, by a network interface of the provider computing system, adverse event data associated with medical product and including a first medical dictionary for regulatory activities (MedDRA) code associated with the first adverse event and a second MedDRA code associated with the second adverse event;

determining, by a processing circuit of the provider computing system, an electronic reference document associated with the medical product;

selecting, by the processing circuit, the electronic reference document including a plurality of defined adverse reactions from the document repository, wherein each defined adverse reaction of the plurality of defined adverse reactions includes an active start date, at least one MedDRA code, and a seriousness exclusion, and

wherein the document repository enforces a system-wide single data source policy by maintaining a single version of the electronic reference document for the medical product;

generating, by the processing circuit, a first case dataset including at least a first portion of the adverse event data;

generating, by the processing circuit, a second case dataset including at least a second portion of the adverse event data;

determining, by the processing circuit, the expectedness of the first adverse event based on a first defined adverse reaction of the plurality of defined adverse reactions and the adverse event data;

determining, by the processing circuit, the expectedness of the second adverse event based on a second defined adverse reaction of the plurality of defined adverse reactions and the adverse event data;

determining, by the processing circuit, a first submission address associated with a first health agency,

wherein the first health agency is the Food and Drug Agency (FDA), and wherein the first submission address is an address associated with the Electronics Submission Gateway (ESG) of the FDA;

determining, by the processing circuit, a second submission address associated with a second health agency;

determining, by the processing circuit, a first submission timeframe associated with the first case dataset based on the expectedness of the first adverse event and at least one: of the first submission address or the second submission address;

determining, by the processing circuit, a second submission timeframe associated with the second case dataset based on the expectedness of the second adverse event and at least one of: the first submission address or the second submission address;

determining, by the processing circuit, a first submission comprising an E2B XML file type and the first submission address based on the adverse event data; and

outputting, by AS2 gateway logic of the network interface, the case dataset as the E2B XML file type to the first submission address based on the first submission.

12 . The method of claim 11 , wherein the first case dataset is output within the first submission timeframe, and wherein the method further comprises:

outputting, by the network interface, the second case dataset within the second submission timeframe.

13 . The method of claim 11 , further comprising:

determining, by the processing circuit, a second submission associated with the second case dataset comprising a second file type and the second submission address based on the adverse event data;

outputting, by the network interface, the second case dataset as the second file type to the second submission address based on the second submission.

14 . The method of claim 11 , wherein the adverse event data includes seriousness data, and wherein the first submission timeframe is determined based on the expectedness of the first adverse event, the at least one: of the first submission address or the second submission address, and the seriousness data.

15 . The method of claim 11 , wherein determining the expectedness for the first adverse event comprises:

determining, by the processing circuit, the first MedDRA code associated with the first adverse event matches the at least one MedDRA code of the first defined adverse reaction; and

determining, in response to the date data being after the active start date of the first defined adverse reaction and by the processing circuit, the first adverse event is expected.

16 . The method of claim 11 , wherein the adverse event data includes seriousness data and date data, and wherein determining the expectedness of the second adverse event comprises:

determining, in response to the date data being after the active start date of the second defined adverse reaction and by the processing circuit, the seriousness exclusion of the electronic reference document at least partially matches the seriousness data; and

determining, by the processing circuit, the second adverse event is unexpected based on the seriousness exclusion at least partially matching the seriousness data.

17 . The method of claim 11 , wherein each seriousness exclusion identifies a seriousness of each adverse event for which each adverse event is expected or unexpected.

18 . The method of claim 11 , further comprising:

indicating, by the processing circuit, the expectedness of the first adverse event in the first case dataset; and

providing, by the network interface, at least a portion of the first case dataset to the user computing device to enable display on a user interface, wherein the user interface includes an expectedness section including the indication of the expectedness of the first adverse event.

19 . The method of claim 11 , further comprising:

providing, by the network interface, at least a portion of the electronic reference document to the user computing device to enable display on a user interface, wherein the user interface includes a defined adverse reactions section;

receiving, by the network interface, the first defined adverse reaction from the user computing device including the active start date, wherein the first defined adverse reaction is received via the defined adverse reactions section of the user interface; and

storing, by the document repository, the first defined adverse reaction in association with the electronic reference document.

20 . The method of claim 19 , wherein the user interface includes a seriousness exclusion drop-down box and further comprising:

receiving, by the network interface, the seriousness exclusion of the first adverse reaction from the user computing device, wherein the seriousness exclusion of the first adverse reaction is received via the seriousness exclusion drop-down box of the user interface; and

storing, by the document repository, the seriousness exclusion of the first adverse reaction in association with the electronic reference document.