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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 […]

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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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How Does E2B(R3) Affect Companies With Global Operations?

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 […]

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Pharmas And CROs: Collaborate In The Cloud With SharePoint 2016

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 […]

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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. The International Organization for Standards (ISO), Health Level Seven International (HL7), and European Committee for Standardization (CEN) collaborated to form the Joint Initiative […]

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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 […]

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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 […]

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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 […]

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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, […]

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Top 5 Life Sciences Blog Posts From May 2016

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 […]

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FDA Draft Guidance: Using EHR Data In Clinical Trials

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 […]

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3 Fundamental Shifts Pharma Needs To Make To Survive Digital

Over the past several weeks, I’ve published a series of posts that focus on segments of an article published by McKinsey & Company called “How pharma can win in a digital world.” (See the bottom of this post for links to the previous posts.) At the end of the McKinsey article, the authors describe “three […]

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Appian’s Journey From Gartner’s Magic Quadrant To Life Sciences

The other day, I was on a business development call in which the Appian platform was discussed. Appian happens to be a “Leader” in Gartner’s 2015 Magic Quadrant for Intelligent Business Process Management Suites. Not too shabby. The presenter talked about Perficient’s successes with Appian in financial services and healthcare, but when I heard him […]

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How To Automate Clinical, Safety, And Business Processes

The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process. Join […]

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Top 5 Life Sciences Blog Posts From April 2016

Now that May 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 April – they’re ranked in order of popularity, with number one being the most viewed piece. From Laptops To Tablets: Eli Lilly Bought […]

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FDA Warns An IRB To Document Its Members And Their Votes

I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete […]

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Using Microsoft Office 365, Quintiles Exemplifies “Progressive”

If you’re an avid reader of this blog, you’ve probably seen several posts highlighting Quintiles, the world’s largest contract research organization (CRO). That’s for good reason. Not only is the global CRO at the top of its game, when it comes to running all aspects of clinical trials for their clients, they’re leading the way […]

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Deploying Risk-Based Monitoring (RBM) Strategies

  In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]

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Top 5 Life Sciences Blog Posts From March 2016

  Now that April 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 March – they’re ranked in order of popularity, with number one being the most viewed piece. 

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3 Things I Learned From Quintiles’ Earnings Call

  If you’re a follower of our blog, you probably know that I enjoy listening to earnings conference calls. They give you a rare look into a company’s operational successes, and sometimes failures. Just last month, Quintiles held their Q4 2015 Earnings Call, which was full of information that gives color not only to the […]

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