An Ode to the eTMF. Sonnet 43, Revisited.
Oh, eTMF, how do you save me? Let me count the ways.
When I extol the virtues of an eTMF application, I am sometimes asked to be more specific and more quantitative. When I say confidently that an electronic Trial Master File system will save money over managing the process with paper-based systems, I am asked how and how much. Fair enough. Here are things to consider on eTMF savings and payback – they might even save your butt.
The Cost of Administration Time
A typical trial master file might include about 20,000 documents. One estimate of the cost to handle documents in US businesses from creation to collection to transmission via fax or mail and updating a ledger or spreadsheet is $10.00 per page, including time and supplies.
That means the administrative costs for handling TMF documents for that typical study would be US$ 200,000. Now, an eTMF system would not eliminate those costs, but it would dramatically reduce them. Let’s be conservative and say that it saves 50% of the paper handling costs – that would be a $100,000 savings.
Storage and Shredding Costs
Study documents have to be retained for specified periods, and 20,000 documents take up a lot of space. Initially, that space may be a room in your offices, but after that, it will probably be at Iron Mountain or another storage vendor.
And after the retention period, the documents will have to be destroyed. It’s hard to estimate those bills, but let’s use $1000 a year for ten years or $10,000 in total.
Need more proof? Check out this infographic on the costs of managing paper documents.
The Cost of Remediation
Paper-based systems inevitably incorporate errors and duplications over time. As files and documents are collected and added to the pile, multiple versions of the same documents go unresolved, unsigned copies remain unsigned, and missing items stay missing.
When either of two events occurs — an inspection or a submission — enormous time and energy will go into preparing for that event. A team will be assigned and deployed to walk through every item, eliminate duplicates, track signatures, find (or create!) missing items, and do a full Q/C pass. How much do ten weeks of a three-person team to remediate the TMF cost? Only you know that, but at $50 an hour, that’s about $60,000.
The Cost of Delays
If the event is a submission, the time required for the remediation will directly delay the submission itself. That, in turn, will directly affect the timing of the desired outcome – approval.
Delays in approval affect the time the drug is on the market (given the fact that drugs have a specific patent-life). So what will ten weeks of having your product off the market cost? It depends on the product, but for a $10 million per year drug or product, the cost, never to be recovered, would be about $2 million.
eTMF Savings and the Avoided Cost of Regulatory Infractions
It is perhaps conceivable that thousands of paper documents can each be handled following regulatory requirements and maintained in an “inspection-ready” status (as required), but it is at the same time completely unrealistic. Those regulations state that TMF documents must be verifiable in terms of authenticity and ready for inspection, which means no duplicates and no missing items.
Meanwhile, privacy regulations say we must at all times ensure the privacy of patient data, so paper-based TMF content has to be reviewed and remediated to ensure compliance.
Failure to meet any of these requirements will mean fines, delays, and (most costly of all) public damage to the brand with a potential impact on the drug path to approval.
Any eTMF system documents every step of every process that includes an essential document collects eSignatures at every appropriate stage, and limits access to study documents to only those who should have access. Searching for PHI is easy and fast. And the TMF is maintained in an inspection-ready state. The price of that compliance, and the easy availability of the proof of that compliance, do not lend themselves to calculation; but it is enormous.
Run the Numbers on eTMF Savings; Then Look Closer at an eTMF Application
Prior generations of eTMF systems could be prohibitively expensive, requiring large projects upfront and high licensing costs. Those systems were developed with “big pharma” in mind, and they could justify the cost.
There are many other reasons that eTMF systems are an essential tool in any clinical study. But “fourth generation” eTMF applications today can have a cost as low as $20,000 per year, or even less. So virtually any sponsor or CRO can justify the cost.
Want to prove it to yourself? Do the following:
- Calculate the number of documents you expect and multiply it by $5 each.
- Add $10,000 for storage and shredding costs (assumes a ten-year life).
- Add $60,000 for the remediation project you will need to clean up the TMF later.
Remember of course that those are just the direct savings for ONE STUDY. How many studies will you be doing? Multiply the result times that.
You probably have already easily justified a modern, fourth-generation, SaaS-based eTMF application with those calculations. But just for fun, take the result and add $2 million for lost time in the commercial phase of a successfully approved product’s lifespan.
Beyond the numbers for eTMF savings, think about what will happen if the FDA completes an inspection and has findings that undermine your company’s credibility and product. Whatever the result from those calculations, they pale compared to the cost of that type of negative publicity or negative effect on the submission and approval process.
So there you go. How can you NOT justify an investment that will deliver that kind of savings, that kind of payback, and reduce that much risk?
Yeah, I know, not much of a love sonnet, I guess. Shall I compare your clinical study to a Summer’s Day instead?
If you want to know the key features of an eTMF application, check out Agatha Clinical, our eTMF application for managing the TMF.