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The Case For Involving Treating Physicians In Subject Recruitment

Clinical Leader recently published an article in which the author and a representative of Pfizer made some really interesting points about the role of treating physicians in clinical subject recruitment. The typical approach to recruitment is to target patients directly. On the surface, this approach may seem patient- or customer-centric, but when you look a […]

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Top 5 Pharma & Medical Device Blog Posts From December 2017

Now that January 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 December – they’re ranked in order of popularity, with number one being the most viewed piece. Shared Investigator Platform (SIP) Struggles […]

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Clinical Study Migrations: Technical Things to Consider

There are a number of essential technical considerations that should be evaluated when migrating clinical studies from one database to another. Is the target database new or does the incoming data need to be “merged” into an existing database? What if the source application has been customized? What obstacles can be expected? Where does regulatory […]

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FDA Guidance On 21 CFR Part 11 And Mobile Tech In Clinical Trials

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. You have until August 21, 2017, to share your thoughts and ideas about its content. The […]

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CX Insights And Journey Maps Improve Clinical Site Relationships

In the previous posts in this series, I’ve explained why you should consider clinical sites as your “customers,” and what customer experience (CX) methodology is and how it’s used. In this post, I’ll explain how the methodology applies to clinical sites and how the insights it provides can help improve site relationships. With the notion […]

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[Webinar] An Intro To Clinical Study Migrations

Migrating clinical studies from one database to another (such as Oracle Clinical to Oracle Clinical or Oracle Clinical to Oracle InForm or Medidata Rave), is a complex process that requires a thorough understanding of clinical data management, technology, and the regulations that govern clinical trials. Join me and my colleague, Richard Gavan, for an informational webinar […]

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Recording Review Actions During A Clinical Data Review

As was mentioned in a previous post, providing an easy-to-use interface is important for data review, including filtering, audit data, and User Review Action buttons. The user actions buttons initiate recording that all, or a portion, of a review has been performed. In the previous section, we mentioned a Review Timestamp, which is one of […]

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Identifying Which Data To Review During A Clinical Data Review

In my last blog post, I presented some thoughts on showing data changed since last review. Today, we will concentrate on the level of scrutiny and what happens when recording the user actions in the review. Not all data may require the same level of scrutiny during a review. Additional focus may need to be […]

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Top 5 Life Sciences Blog Posts From January 2017

Now that February 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 January – they’re ranked in order of popularity, with number one being the most viewed piece. 4 Ways You Can Improve […]

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Digital Technology In The Subject Screening Process

Subject screening adds significant cost to a trial, so it’s an ideal process to try to streamline. Subjects who don’t meet eligibility requirements ultimately lower the efficiency and ROI of a trial, since time and money was spent on those assessments. The screening process is one area that presents an opportunity for cost-savings, whether it […]

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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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Transfer Subjects From Site To Site With Siebel CTMS IP2016

Study managers, rejoice! In Oracle’s innovation pack 2016 (IP2016) for Siebel Clinical, Oracle introduced a new feature that allows subjects who are enrolled at one site to be transferred to another – without losing any history. Here are some highlights of the subject transfer feature: Ability to transfer subjects from one site to another within […]

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