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How To Fix Clinical Data Entry Mistakes At Clinical Sites

Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and cleanup slow down time to market and increase development costs, dirty data can stall or even kill a new drug application (NDA). Consistently receiving dirty data from sites can seriously damage a sponsor’s or contract research […]

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How To Fix Ineffective Subject Screening At Clinical Sites

Even when sites are able to recruit a large pool of potential subjects, sponsors and contract research organizations (CROs) see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject […]

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Incoming Novartis CEO Looks To Disney For Inspiration

On September 4, 2017, Novartis announced that its current CEO, Joseph Jimenez, will step down from his role in February 2018. He will be replaced by Dr. Vasant Narasimhan, the company’s current global head of drug development and chief medical officer. The backgrounds of the two executives couldn’t be starker. Mr. Jiminez has very little […]

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How To Fix Slow Subject Recruitment At Clinical Sites

Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management and/or the sponsor organization to meet recruitment targets causes stress and anxiety for study managers, which in turns strains their relationships with underperforming sites. This tension can be alleviated by helping sites: Broaden their pool of potential subjects […]

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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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Release Notes: Oracle/Perficient’s Clinical Apps [October 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Top 5 Pharma & Medical Device Blog Posts From September 2017

Now that October 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 September – they’re ranked in order of popularity, with number one being the most viewed piece. How Merck & Facebook Are […]

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How Merck & Facebook Are Pushing The Bounds Of Patient Recruitment

In December 2016, my colleague wrote about various technologies that can help pharmaceutical and research organizations help recruit clinical trial subjects. One of the applications Param Singh, our director of clinical operations and connected health for life sciences, highlighted is called Antidote Match: “Antidote Match, which uses natural language processing, artificial intelligence, and an army […]

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Release Notes: Oracle/Perficient’s Clinical Apps [September 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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What The FDA Requires Of Drugs On The Market

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

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Post-Market Surveillance Of Drug Safety

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

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Oracle Data Management Workbench Overview And Use Cases

This Thursday, Perficient is hosting a webinar on Oracle Data Management Workbench (DMW) alongside Oracle, one of our most valued partners. From Perficient, we’ll have Prabha Ranganathan, the director of clinical data warehousing and analytics, and from Oracle, we’ll have Srinivas Karri, the director of product strategy for DMW. Yesterday, I got a sneak peek […]

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Release Notes: Oracle/Perficient’s Clinical Apps [August 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Top 5 Pharma & Medical Device Blog Posts From July 2017

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. All You Need To Know […]

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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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Applying The Concept Of Customer Experience (CX) To Life Sciences

My colleagues in Perficient Digital, Perficient’s in-house digital agency, recently published a fantastic guide about customer experience (CX). While the guide focuses primarily on retail customers, a lot of the advice it contains can be quite helpful for life sciences, so I thought I’d take a stab at translating it for you. Now, in full […]

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Role Of Clinical Trials In The FDA Drug Approval Process

Last time, I published the second in a brief series of blog posts designed to provide insight into why prescription drugs in the U.S. cost as much as they do. The series is focused on explaining the FDA drug approval process in layman’s terms. My previous post focused on the first stage in the process, […]

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Release Notes: Oracle/Perficient’s Clinical Apps [July 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Key Takeaways Re: CX And Your Relationships With Clinical Sites

In the previous five posts in this series, I’ve taken you on a little journey designed to help you improve your relationship with your clinical sites, thereby boosting their performance and reducing your costs. In this, the final post in the series, I’ll summarize the key takeaways and offer up some additional resources to help […]

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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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