Posts Tagged ‘pharma’

Imagine with me: While a physician is browsing your website for information on your products, he comes across an invitation to apply to become a principal investigator in one or more of your clinical trials. He clicks the link, fills out a detailed profile, and submits. The system automatically notifies you that a new profile […]

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 […]

The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57. The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to […]

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 […]

If you’re in the biotech business, you’re likely closely following the Sarepta saga, or, at the very least, you’re hearing about it in passing because everyone around you is talking about it. Sarepta Therapeutics, a Cambridge, Massachusetts-based company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and […]

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 […]