Posts Tagged ‘clinical trials’

In August of last year, I wrote a blog piece that discusses the possibility of GlaxoSmithKline (GSK) being one of the first pharmaceutical companies to use Apple’s ResearchKit. It appears that possibility has become reality. According to Bloomberg, the global pharma company will be leveraging a mobile app they created on ResearchKit to obtain information […]

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 […]

Imagine with me: On your website, the site coordinator finds the option to create a user account. After successfully creating an account, she logs in and sees a site-specific view of the information you have in your clinical trial management system (CTMS) about her site. One of the things she notices is that the address […]

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 […]

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 Accel-Account Manager Accel-Copy ASCEND (Siebel CTMS) Generally speaking, […]

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 […]

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. Pfizer Says “Yes” To Oracle What Is […]

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) […]

Very good news out of Oracle this week. After a thorough review of solutions on the market, Pfizer chose to implement what can essentially be seen as Oracle’s complete suite of clinical and drug safety applications. This doesn’t necessarily come as a surprise, since the pharma company has been a long-time user of Oracle’s legacy […]

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 […]