E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]
Posts Tagged ‘CRO’
Happy May Day! Top 5 Life Sciences Blog Posts From April 2017
Happy May Day! 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. My Colleagues […]
[Webinar] Upgrading Siebel Clinical To IP2016 & Preview Of IP2017
Because Siebel Innovation Pack (IP) 2016 was such a significant departure from previous Siebel versions, our clinical operations team devoted much of last year to beta testing it, helping Oracle identify and iron out the kinks. Now that we have finished our assessment of the risks and rewards of upgrading Siebel Clinical to IP2016, we […]
My Colleagues Just Solved A Clin Ops Business Problem With…What?
With Appian. Yes, Appian. “I have no idea what that is…” Yes, I can read your mind. Okay, okay, I’m not actually clairvoyant. But I do have a pretty good sense of the industry, and I know that Appian hasn’t become a household name, yet. But, the times they are a-changin’. Appian is a business […]
Duke & FDA Study On Investigator Retention Shows 54% Turnover
Last month, Duke University and the FDA released the results of a jointly conducted study on principal investigator (PI) retention. The study was released early online, but the print version is being published in June in the journal of Contemporary Clinical Trials Communications, published by Elsevier. The purpose of the study was two-fold: 1) to […]
Troubleshooting Workflows In Siebel Clinical
Recently, one of our Oracle Siebel Clinical Trial Management System (CTMS) clients noted that the rollups feature, which collates information from lower levels of the data type hierarchy into a single view (e.g., all site records within a single region or country), was not working properly. Specifically, the fields that indicate the number of subjects […]
How To Fix The Sponsor/CRO-Site/Investigator Relationship
Many moons ago, I wrote the blog post This Is Bad News For Sponsors And CROs, in which I shared how the number of principal investigators interested in running new trials had declined. Another blog post from several several years ago, Wait, You’re Not Using an Investigator Portal?, shared one method of increasing satisfaction among […]
Sites Ask Sponsors And CROs, “Where’s The Love?”
According to the 2016 Summit Site Landscape Survey, which was conducted by the Society for Clinical Research Sites, the majority of clinical sites aren’t feeling the love from sponsors and CROs. Of the 463 survey respondents, only 31% felt their relationship with sponsors had improved in the past two years, and only 25% felt that […]
What Connected Health For Life Sciences Means For You
It seems every company in every industry is talking about “going digital.” But, what does that really mean? At its heart, going digital is really just about relationships: relationships with customers, partners, team members, and the world at large. Since the introduction of mobile and digital technology, the ways in which we interact with others […]
Oracle Siebel CTMS Now Supports Satellite Sites
The satellites are finally in orbit! In Oracle’s innovation pack 2016 (IP2016) for Siebel Clinical, they introduced a new feature that allows clinical sites to have satellite sites organized beneath them. Here are some highlights of the satellite site feature: Multiple satellite sites can be defined for an individual parent site Parent site data defaults […]
What Are The Implications Of Not Complying With E2B(R3)?
In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]
Do Commercially Available Safety Systems Comply With E2B(R3)?
Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]