What? I’m not losing data!
Actually you are.
It is correct; you have not had a major IT system crash in years. And even if you did, systems are being backed up on a regular basis and are recoverable.
And, it is true; you may have had issues with people storing data in the wrong place in the past, but those have primarily been resolved through training.
The primary contributing factor for losing information today is actually not due to IT systems failure or a lack of discipline of employees placing documents and artifacts in the incorrect location. In reality, information or knowledge loss comes from employee attrition.
Talk to your head of human resources, and they will give you ten reasons why your employees are your most valuable resources. Today, we will talk about one that might not appear on HR’s list.
For the pharmaceutical industry, it is common for an attrition rate of XX%[1] among fulltime employees. According to one survey, the contract research organizations (CROs) you rely on has a 12.5%[2] rate. The same study claims a 29% attrition among the clinical research associates (CRAs).
Attrition rates are dropping for pharmaceutical organizations, but it appears the retention rates are simply being transferred from the drug owner to the CRO. The resource retention risk still persists even as you become more dependent on CROs.
What is the point of improving your attrition rate through contracting it out if the net-net is the same or worse?
For the sake of easy math (and to account for the possibility the research is slightly exaggerating the attrition rates), let’s assume that the rate is 10% employee loss on an annual basis.
If you think of the typical length of time to research and develop a drug, it may take up to 7 years. If you have a team of 100 people assisting with the effort, then by the time you complete the research activities leading up to application submission you will have a nearly complete turnover in personnel. You could end up with as few as 30 people that were there at the beginning of the initiative that are still there at submission.
It is no wonder why the volume of resubmissions to the FDA has not decreased (in spite of new controls and policies for increasing attention to detail).
It isn’t surprising why you still haven’t figured out how to trim time off of the preparation activities (even after leaning out your processes and retooling schedules).
Even cutting a month off of the overall timeline could save your organization tens of millions of dollars.
What you need to start thinking about is consolidating information and your tracking systems. By creating a single tool of engagement, the history is retained whether completed by a full time employee or CRO staff. When a resource departs, their coworkers or replacement can pick up exactly where they left off without duplicating effort.
Both direct employees and CRAs (across all CROs involved) need to be in the same system to reduce the risk and ultimately the cost of turnover.
[1] According to the Bureau of Labor and Statistics – http://bls.gov/jlt/…
[2] According to a study conducted by outsourcing-pharma.com – http://outsourcing-pharma.com/Commercial-Services/Survey-CROs-See-Rise-in-Employee-Turnover-Rate-Less-Retention-Bonuses