Have you ever stopped to count the number of different applications and systems involved in getting your company’s products from clinical trial to regulatory approval and product launch – not to mention doing variations? In the worst case, you’ll run out of fingers on both hands before you stop counting.
There is the CTMS holding your patient information, budget and clinical data. And the myriad of documents stored in your EDMS and eTMF. The QMS that your Quality needs to make sure everything is up to code as well as the RIMS you need for regulatory registration and approval.
The list quickly grows. And while the individual applications may be robust and well suited for that specific task, they are often not designed to work together. That hurts your organization’s efficiency, time-to-market and ability to compete.
As an eye-opening exercise, try mapping out the individual steps and time spent on relatively simple tasks – like verifying that your Submission Report was sent on schedule, creating a Health Authority Contact Report or indexing a document file.
First off, check whether you can accomplish the task on your own, or if you need to contact someone else, inside or outside your organization. If you are lucky, the communication can be handled with a quick email, phone call or just a question to the person sitting across from you. But what if that person is stuck in a meeting or your email sits unopened in an overstuffed inbox? Suddenly, what should have taken no more than a couple of minutes can take hours, sometimes stretching over several work days.
Next, keep track of the different steps involved in what you’re doing. Do you find yourself moving data from one application to another, entering the same meta-data multiple times or saving your work locally to make sure you don’t lose it in the process? How many times have you had to open or close a window or type something manually? How many different applications did you use? Can you brew a fresh cup of coffee and drink it too before your system is done uploading and rendering your latest input?
Apart from the time that is lost due to inefficiency, there is also another aspect to consider when working across multiple applications – compliance!
Can you ensure that any changes you might have made have been updated consistently across applications? And if your clinical trial manager changes something in the eTMF, will those changes affect the work your Quality Control staff is doing, the application your Regulatory Affairs is preparing or the claims your marketing department included in the latest content? Without a unified system acting as a single source of truth, how will you know which information to trust if conflicts occur?
A final aspect to consider, is the loss of efficiency due to inefficient reuse of content. Experience shows that countless hours and resources are spent producing material that could easily be assembled from existing data or content. But due to a lack of transparency and cross-application functionality, the people doing the work rarely realizes that the information is already available.
So, what can life sciences companies do to improve efficiency? A main reason for the ineffective state of affairs is that the many different applications needed by pharma companies have been developed to handle a narrow task and are effectively function as silos, trapping your data.
Fortunately, today there are unified cloud-based systems available that can handle all the needs of the life sciences company, from clinical operations and data management to quality and regulatory affairs. This means that the technical barrier is gone, and the right tools are available to enable greater efficiency across the entire organization.
And while the task of choosing the right unified platform, migrating all your data, performing the necessary validation afterwards should not be underestimated, the benefits of a unified platform will quickly outweigh your investment.
For a detailed introduction to the benefits of moving to a unified platform like Veeva and the steps involved in implementing it, please see our upcoming webinar.