Posts Tagged ‘CRO’

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 […]

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 […]

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 […]

Currently, two of the FDA branches have released guidance documents and have implemented a form of E2B(R3). Center for Biologics Evaluation and Research (CBER) has released “Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines” and the Center for Devices and Radiological Health (CDRH) has released “Technical Information on eMDR.” While both of […]

While patients continue to need life-saving drugs and devices, pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) are under immense pressure to develop products quickly without sacrificing quality, efficacy, or safety. Not only are these companies expected to deliver therapies faster than ever, they are expected to make them more affordable. Faced with […]

After the release of E2B(R2), the ICH realized that technical specifications should no longer be developed in isolation. E2B(R3) is the first technical specification to be developed through a new collaborative approach. E2B(R2) Vs E2B(R3): Regulation and Interoperability The International Organization for Standards (ISO), Health Level Seven International (HL7), and European Committee for Standardization (CEN) […]

Electronic document management systems (EDMS) offer excellent version control functionality, but, when it comes to collaboration, they tend to be…clunky, at best. SharePoint 2016, on the other hand, offers the best of both worlds: the security of an EDMS and the collaboration tools of, well, SharePoint. Here’s an example of how a global pharmaceutical company […]

E2B(R3) doesn’t have a direct translation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidelines that have designated “E” to stand for efficacy. The work carried out by ICH under the efficacy heading relates to the design, conduct, safety, and reporting of clinical trials. It also […]

The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]

SharePoint 2016 is changing the face of digital engagement in life sciences. There’s no doubt that it’s one of the most effective collaboration tools on the market, but what you might not know is that it also supports an innovative customer-facing experience. Take a look at how, following the merger of two global pharmaceutical companies, […]

Now that June 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 May – they’re ranked in order of popularity, with number one being the most viewed piece. Gartner’s List Of 5 Cool Vendors […]

We’ve talked a lot in this blog about the use of electronic health records (EHRs) in clinical trials. Recently, my colleague wrote about it on our healthcare blog, so, I thought I would share her post with my pharma and CRO friends. While our previous posts focused on the use of EHR for subject recruitment […]