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Posts Tagged ‘drug safety system’

Release Notes: Oracle/Perficient’s Clinical Apps [August 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Release Notes: Oracle/Perficient’s Clinical Apps [July 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Top 5 Pharma & Medical Device Blog Posts From June 2017

Now that July is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

Consider This When Migrating To Argus Safety

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

Release Notes: Oracle/Perficient’s Clinical Apps [June 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Release Notes: Oracle/Perficient’s Clinical Apps [May 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Release Notes: Oracle/Perficient’s Clinical Apps [April 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

What Are The Implications Of Not Complying With E2B(R3)?

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]

Do Commercially Available Safety Systems Comply With E2B(R3)?

Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]

Does E2B(R3) Impact Companies With No Safety Reporting System?

The issue is not the type of system used to collect adverse event data, but rather how the data is submitted to the FDA, EMA, and MHLW. If an organization is using spreadsheets to collect safety data or is unable to transmit data via E2B, it will have to report the data via a web-based […]

What Is The Pathway To E2B(R3) Compliance?

Companies who are currently submitting reports using the E2B(2) format should already be planning the move to E2B(R3). If a robust safety and pharmacovigilance system is already in place, there are likely just a handful of technical changes that need to be made in order to meet the new regulations. For example, system configuration changes […]

When Do Companies Have To Begin Complying With E2B(R3)?

In the United States, if a company is transmitting vaccine or device information to the FDA, it should already be reporting in E2B(R3) format. For companies reporting solely to the FDA Adverse Event Reporting System (FAERS), no official deadlines have been published. In Europe, drug companies who report to the EMA will need to comply with […]

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