Posts Tagged ‘clinical studies’

Informed consent, an integral part of clinical research, ensures that clinical trial participants are well-informed about all the relevant aspects of the clinical trial and that their participation is voluntary. However, as clinical studies get more complex, informed consents are getting longer and less clear, defeating their intended purpose. According to a survey, 35% of […]

Our Life Sciences and Data Solutions practices built a new platform to help analyze clinical trials The rigorous process for developing new drugs and therapies is rigorous, and only one out of every 10 medicines makes it through to the regulatory submission and approval. Non-compartmental analysis (NCA) is an essential activity within the drug development […]

The beauty of having a versatile team of clinical data management experts is that they understand the life sciences industry and how companies operate. Through client projects and having worked at pharma companies in previous roles, they know the many unique challenges and needs of pharmaceutical and medical device companies. Equally important, they’re also technologists. […]

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 […]

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 […]

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 […]

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.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 […]

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 […]

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 […]

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 […]

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 […]

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 […]