The Challenges of Pharmacovigilance: Database and Reporting Solutions

In recent years, regulatory agencies - including the EMA/European Union and the FDA - have taken steps to improve patient safety in clinical trials. The EU estimates that approximately 200,000 patients die each year from Adverse Drug Reactions. Companies are often faced with the challenge of finding solutions that can improve quality and analysis of safety data while managing the increase in data and the need to satisfy regulatory requirements.

In Europe, the latest pharmacovigilance regulations, known as Good Pharmacovigilance Practice (GVP), went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports.

 

Safety Database

 

Companies conducting pharmacovigilance activities will need a safety database that can optimize safety reporting. Many pharmaceutical and biotech companies may opt for Oracle AERS or Argus, while some store safety data in SAS. Oracle AERS is a comprehensive solution for product safety monitoring and compliance. The graphical user interface allows users to visualize the case elements and understand the holistic case picture. Oracle Argus, on the other hand, is a fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-market surveillance. 

 

Combining statistical analysis, programming and IT support under a commonly used platform like SAS is an ideal solution for automating data collection and analysis from multiple sources. This approach is even appropriate for smaller companies, because automation can be done without a complex or expensive Business Intelligence platform.

 

Customized Reporting Solutions

 

1. Automating signal detection in SAS is one ideal solution for customized reporting. In order to automate the process, a system needs to be in place to pull and analyze data from the safety database. The key aspect is the data integration between safety database, regulatory databases, and patient data from external database resources. The identification of signal criteria and the implementation of standardized programs automates the signal detection process and produces structured data which speeds up the task of finalizing Eudravigilance submissions.

 

2. Integrating an Oracle database with Business Intelligence produces real time data and results. With the support of our technology partner, we can integrate Oracle 9i database with Oracle Business Intelligence Standard One edition to create interactive dashboards for readily accessible data and results.

 

The good, the bad and the ugly side of using social media for your job search. Part 2

Facebook

In the last blog, Kubo looked at LinkedIn and how it can help your job search, but what about when something you have said or done online comes back to bite you! This week Kubo are looking at Facebook, and like many people, you probably think that LinkedIn is for professional use and Facebook is for personal use, but unfortunately social media doesn’t work like that. What you say and do on your personal profile has a habit of catching up with you when you least expect it.

Most employers will Google their prospective employees before their interview, so your chosen profile picture and past pictures are the first thing an employer can see in search results. This is probably a good time to check your privacy settings and make sure your profile is set as private and be sure to select an appropriate profile picture, because these are viewable to everyone!

Whatever is viewable on your Facebook timeline tells an employer about you. If you don’t want future or current employers looking at your recent posts then lock it down via your privacy settings, because what you post may well hinder your chances of getting that job! Below are examples of how Facebook has cost a few people their job!

• In 2009 a female employee had a bit of a moan on Facebook about her new job “first day at work. omg So dull!! Unfortunately for her this post found its way to her manager and 3 weeks later she was fired! 

 

• In March 2009 a Swiss women was fired after phoning her boss and telling him she couldn’t come in because she had a migraine and the lights and glare from her computer would make it worse. She was later seen on Facebook and it was presumed if she was well enough to be on Facebook she was well enough to be in work! She was subsequently let go!
• It’s never advisable to criticise your boss on social media, especially when you have them as a friend on Facebook! Below is the actual response that this young lady got from her boss! 

 

• A male employee in the UK wrote this on his Facebook page, ‘I work at [insert company here] and can't wait to leave because it's s***"." He quickly got his wish and was sacked!!

 In many cases, potential employers can find their way onto your Facebook page even if you have enabled privacy settings by going through other employees or friends. So be careful what you post on Facebook and who can view your profile.! The first thing most potential employers do is Google or Facebook their candidates. Start by doing a Google search of yourself and see if you are happy with results. Don’t stop yourself getting that perfect job by having incriminating evidence on your Facebook. Once you do have that job think carefully what you write as you may well find yourself without one!

Let us know if you have ever got into trouble over a post you have wrote?