Life Sciences

It’s been awhile since I’ve written about FDA warning letters, so I thought I would take a look at the letters issued throughout the year and see if anything egregious (or at least interesting) came up. I was surprised to learn that the FDA issued letters to six separate clinical investigators, and I thought the […]

You know how you implemented that regulated IT system a few years ago, and it was all shiny and new, and then it went through a bunch of change controls and the validation documentation got kind of unwieldy, and now you’re kinda wishing you could start over with a clean slate, but without losing the […]

It’s been a long time in the making, but it’s finally completed. Janssen, a pharmaceutical company owned by Johnson & Johnson, just unveiled a new digital site, Cancer.com. The new site provides patients, caregivers, and loved ones with loads of content and resources. It even offers users the ability to customize and personalize the site […]

At any given time, a principal investigator (PI) can be working on one or more studies for a single sponsor company, or multiple studies for multiple sponsors. Likewise, each sponsor runs its clinical trials its own way, using its preferred technology and processes. And, often times, the technology and/or processes differ from study to study, […]

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 […]

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 […]

Now that December 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 November – they’re ranked in order of popularity, with number one being the most viewed piece. Top 25 Biotech Companies European […]

Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019. In a press release, the European Medicines Agency (EMA) said: “The guidance document outlines the practical and simplified […]

This is perhaps the biggest complaint we hear from both sponsors/contract research organizations (CROs) and sites/investigators. Sponsors and CROs dedicate countless resources to researching and addressing payment questions and concerns raised by site personnel, and site personnel often feel frustrated, undervalued, and distrustful of sponsors and CROs that do not pay them as promised. When […]

The European Medicines Agency (EMA) is will be moving its offices from London to Amsterdam, due to the UK’s decision to withdraw from the European Union. According to a press release issued by the EMA, the relocation effort needs to be completed by the end of March 2019. The EMA currently employs close to 900 […]

At first glance, having outdated contact information for sites might seem like a pretty minor issue. But when it results in delays related to required documents, monitoring visits, or clinical supplies, the issue quickly becomes more serious. It might be easy to keep a sponsor or contract research organization (CRO) in the loop when a […]

We’re all intrigued by rankings and flock to them for good reason. When it comes to ranking companies by market capitalization, you can assume that the named companies are leaders in their own right. They never stop innovating. They never stop changing. They never stop investing in their business. These are companies that we can […]