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[Guide] 2018 Pharmaceutical And Medical Device Industry Trends

Knowing for certain what the future holds is impossible. Trends, on the other hand, are more predictable. In fact, there’s probably no better indicator of emerging or future trends than recent history. That is exactly how we determined the trends we anticipate seeing in the pharmaceutical and medical device industries in 2018. This guide does […]

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7 Ways To Fix Your Relationships With Clinical Sites

In our nearly 20 years of working with the life sciences industry, we’ve spoken with countless pharmaceutical, medical device, and contract research organizations (CROs) about their relationships with clinical sites and investigators. We’ve listened to their struggles and the things they’ve done to try to make things better, including what’s worked and what hasn’t. We’ve […]

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Customer Experience (CX) Dimension #1: Customer Insight

The first of the seven customer experience (CX) dimensions discussed in Perficient Digital’s CX strategy guide is Customer Insight. As I’ve discussed in the previous posts in the series, in life sciences, “customer” means many things: patient, physician, clinical site, clinical subject, research partner, regulatory agency, vendor, and even employee. To provide each of these […]

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The Marriage Of Life Sciences And Retail

In today’s post, which is part of a series aimed at applying my colleagues’ customer experience (CX) strategy guide to a life sciences audience, we’re getting up-close and personal with retail. Perficient Digital’s CX strategy guide includes a number of statistics from myriad sources (see guide for sources) about the buying process in the Age […]

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Life Sciences Is Not Immune To The Age Of The Customer

This is the second post in a series about applying customer experience (CX) principles to life sciences. In the first post, I discussed a critical underpinning concept for the blog series related to how “customers” are defined in life sciences. Here’s a quick recap: Since patients don’t typically buy their medications or medical devices directly […]

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Top 5 Pharma & Medical Device Blog Posts From June 2017

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. What Exactly Is An “Adverse […]

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Consider This When Migrating To Argus Safety

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

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EudraVigilance: Some Things To Consider Right Now

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 […]

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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 […]

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[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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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