In this day and
To ensure safety and efficacy, any data associated with a pharmaceutical product must be “attributable, legitimate, contemporaneous, original, and accurate.”
-Darren Barrington-Light, Biopharm International
Since I have been in the industry there have been buzzwords and phrases coupled with increased attention towards making your data as effective and imperative as possible. ‘Big Data’, ‘Real World Experience’, are buzzwords thrown around constantly; there are even jobs created to ensure that data are the focus – the data scientist. All in an effort for recognition that it is vital to control, organize and monitor the integrity of your data.
As greater amounts of data are generated by people involved in, providing and manipulating data it is tough to navigate the path of more data and less processing time coupled with tighter restrictions and a focus on maintaining compliance and integrity.
How do we successfully navigate through this process to optimize how we use our data?
The first consideration is to develop continuity in data storage. Data comes into an organization in multiple formats and presentations, with no standardization. Although an arduous task to organize, if data is organized in consistent formats for easy retrieval, review and presentation of data becomes a simpler, more streamlined process. Determining critical relevance in your data from the start allows for data organization that provides easy retrieval and usage, thus making your data more accessible than previously. Preparation of submission and filings becomes more manageable, in order to meet milestones and filing deadlines.
Technology has improved over the years to allow for document organization, data
Utilizing a method of organizing, tracking and managing data ultimately allows the data to work for you.