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Life Sciences

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 […]

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 […]

Four Steps To Assess And Mitigate Risk With Regulated IT Systems

Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]

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 […]

How To Manage Your Aggregate Spend And Sunshine Act Reporting

Imagine with me: In support of your required Physician Payments Sunshine Act reporting, you integrate all of your physician payment source systems to a single platform. Some of those systems are fully integrated, while other systems – mostly legacy, built on older technology – are integrated using robotic process automation (RPA). Over the course of […]

How Great CX Drastically Increases Revenue, Even In Life Sciences

If you’ve been following this blog series, hopefully you’re coming around the idea that it’s wise to consider all of your stakeholder groups – patients, physicians, clinical sites, vendors, partners, regulatory agencies, investors, even your employees – as “customers.” In today’s post, we’ll look at the portion of Perficient Digital’s CX strategy guide that talks […]

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 […]

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 […]

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 […]

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 […]

How To Use SmartScripts For Trip Reports In Oracle Siebel CTMS

Starting in Siebel IP2013, a little known enhancement was introduced in Oracle’s clinical trial management system (CTMS): the ability to incorporate Siebel SmartScripts directly into trip reports. What are SmartScripts? According to Oracle’s official documentation, “Siebel SmartScript allows business analysts, call center managers, and Siebel developers to create scripts to define the application workflow for interactive customer communications. […]

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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