Why Managing Digital Information is Important for Startup and Small Life Science Companies
Most startup and small pharma and biotech companies believe that managing data, document storage, security, file sharing, and online collaboration are considerations for the ‘future.’ It is a common misconception that IT issues will only have to be addressed ‘when we have more money,’ or when the organization has grown enough to hire an IT professional to look after those tasks. Is that the right way to think and is that a safe decision?
Common thinking among this group is that putting qualified and validated solutions in place prior to your first Phase II or Phase III trial is somewhat of a waste and excessive. But in reality, the sooner you put into place proper processes for managing your digital information, the better and more beneficial it will be.
Startup and small pharma and biotech companies often use data pulled out of an academic lab environment or from a laboratory incubator that they have been involved with. Or, perhaps bought a compound from a large pharma company. Either way, one thing may not have been realized is the transferring of data from a network file location to your database that can pose many unforeseen future risks for your company. There is a lot that can go wrong. For example, there is the possibility that some of the special characters in the file names might not transfer over properly. Or, there is the possibility that you might be missing several vital files without even knowing it.
That said, for most smaller companies, it is faster and easier to share data and documents through online tools such as a shared drive, Box, DropBox, or Amazon Cloud. These tools are easy to set-up and use but they may not meet FDA requirements. The question that still arises for startup and small life science companies is: Do you truly need to be concerned with how you store and share your data even before you start dealing with clinical trials? The answer is a resounding ‘YES!’
Why early planning is important
Paying early attention to data issues is quite crucial for biotech and pharma companies, and the straightforward reason behind this is, FDA 21 CFR Part 11. Under the Code of Federal Regulations, the United States Food & Drug Administration (FDA) regulates the handling of electronic records as well as electronic signatures (ERES), in Part 11 of Title 21.
So, when you are ready to prepare your data for regulatory submissions, you will be faced with a whole lot of requirements in 21 CFR Part 11 regarding how data from your early R&D needs to be stored and shared. Therefore, it is essential from the beginning that any system you are using to produce data for regulatory submission is in a verified validated environment.
The reason is the FDA needs to be sure that you have had control of that data and that no one was able to alter or modify it in any manner. The regulators will not entertain any explanation stating that you did not have control over your personal data. The early use of inexpensive tools is not an acceptable justification since many of these online tools do not fully comply with the security and data requirements of the FDA. All of this ultimately means that your data is your own responsibility, and therefore, you should have had full control and knowledge of it from the get-go.
Managing data early saves unwanted hassles
In the case of managing data for pharma and biotech companies, early actions will save you from unwanted aggravations down the road.
Many companies are stunned when they have finally reached the point of organizing data for FDA submissions. Despite exciting growth potentials, many startups and small companies are dismayed to find out how much back tracking and re-engineering of their data is required. The costs of remediation can be staggering. An early investment in a solid technology foundation is far less than the later expenses of remediation.
There can be much ambiguity. You may find that you are missing necessary data because people have renamed files or moved them to a temporary location while they were “fixing” something. You may have multiple versions of documents and no one can figure out which was the latest version. These are just some of the challenges that happen regularly to startup pharma and biotech companies who wait to put proper processes and tools in place for managing their digital information.
The delays caused by remediation are both costly and time consuming. Remediation will add substantial unforeseen expenses and can cause significant delays in your submission and approval process.
The lesson is simple: A small upfront investment in planning your IT will mean sizable cost and time savings down the road.
