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MedDRA Upgrades: 4 Clarifications

We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017. Our clients often have questions about upgrading their […]

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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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Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

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FDA Ciphers Update: What To Consider If You Have Argus Safety

The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]

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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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Oracle Clinical 5.2 Released: 7 Changes To Know

It’s been almost two years since I wrote that Oracle Clinical and Oracle Remote Data Capture (RDC) 5.1 was released. Well, today I can say that 5.2 has been released and is available to anyone who is looking to upgrade. While 5.2 is not considered a major release, it is an important one, as it […]

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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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Argus Safety 8.1.1 – 2 Things To Know

Oracle Argus Safety 8.1.1 was officially released today, so I thought I would share a question that came up recently from a hosting customer. The customer asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that companies should […]

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How To Streamline Investigator-Initiated Trial (IIT) Proposals

Imagine with me: One of your experienced investigators comes up with a brilliant idea for an off-label use of one of your medications. He logs in and navigates to your online IIT proposal form, which only he and other experienced investigators can see. He begins completing the form online using interactive prompts, and uploads supporting […]

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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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Top 5 Pharma & Medical Device Blog Posts From August 2017

Now that September 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 August – they’re ranked in order of popularity, with number one being the most viewed piece. What The FDA Requires Of […]

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How To Enable Self-Screening For Subjects At Clinical Sites

Imagine with me: A potential clinical subject comes into a site for her screening visit. When she checks in, she is issued an iPad for use during the visit. On the iPad, she finds an interactive app that leads her through the screening process, step by step. It moves her through questions dynamically, using a […]

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How To Make Clinical Subject Screening Easier On Clinical Sites

Imagine with me: A potential clinical subject comes into a site for his screening visit. The nurse performing the screening visit takes out her iPad, brings up the screening app, and follows the interactive prompts to move the potential subject through the various questions and tests. When the nurse selects or inputs the potential subject’s […]

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What Is Internet Of Things (IoT) For Clinical Data Collection?

Imagine with me: After successfully enrolling in a clinical study, a subject is issued a wrist tracker and a digital skin patch, and is given login credentials for a proprietary app to download on her mobile phone and tablet. Over the course of the study, her wrist tracker and skin patch continuously collect and transmit […]

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How To Make Site Monitoring Reports Easier And More Transparent

Imagine with me: Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails. The day of the visit, the monitor arrives at the […]

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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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How To Make Subject Diaries More Valuable In Clinical Research

Imagine with me: Once successfully enrolled in your study, a clinical subject is issued login credentials for a proprietary mobile app he downloads onto his phone. Over the course of his participation in your study, he receives push notifications to remind him to log periodic diary entries. In the app, he follows interactive prompts that […]

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