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 […]
Life Sciences
What Is The Difference Between E2B(R2) And E2B(R3)?
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) […]
Manage Regulatory Submissions And SOPs With Microsoft SharePoint
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 […]
Pfizer Says “Yes” To Oracle
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 […]
What Is E2B(R3)?
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 […]
Giving Patients A Digital Voice As The FDA Reviews Sarepta’s NDA
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 […]
Microsoft SharePoint: A Collaboration Space For Partner Companies
Since the introduction of SharePoint 2016, the industry has been buzzing about how much easier and better digital collaboration has become, especially between partner companies. Here’s an example of how two large pharmaceutical companies are using SharePoint as a collaboration space for their joint drug development projects: Each organization had its own validated electronic document […]
E2B(R3): Inside Scoop For Product Safety Teams In Life Sciences
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 […]
Microsoft SharePoint As A Unified Post-Merger Platform
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, […]
If You Use Siebel CTMS, Medidata Rave, Or Veeva Vault…
Then we’ve got a special webinar, just for you. On July 21, we will be having a fireside chat with our client, Alliance Foundation Trials (AFT), a research organization that develops and conducts cancer clinical trials. The chat will include a few presentation slides, so that you’re not looking at a blank screen, but much […]
Microsoft SharePoint For Clinical Development Plans
There’s been a lot of talk recently about SharePoint 2016. This latest version is especially appealing to life sciences companies because it supports the flexibility of a hybrid on-site/cloud implementation. That means that organizations who aren’t quite ready to fully embrace the cloud have the power to host certain features in-house behind their firewall and […]
Release Notes: Oracle/Perficient’s Clinical Apps [June 2016]
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, […]