I have written several articles recently about companies in the pharma industry that continue to use paper for clinical trials when technology now exists to make all of it obsolete. Folks involved in the process have also given me opinions on why there is a reluctance to part with it. Theories range from the conservative, risk-averse nature of pharma companies, concerns over cost, and even older employees in regulatory oversight positions that did not grow up in the electronic age in which we currently live. But as a new guard comes along and people become more confident with electronic solutions, the trend may finally be shifting.
“When you look at what the cost is of continuing to handle large quantities of paper, not just the monetary cost but also the cost to the environment, it is just enormous,” says Sandra Freeman, Senior Director of Customer Success for goBalto. “As we come up with new systems that not only drive but better document the business, and provide better audit trails to what is going on, I believe we will begin to see much less reliance on paper.”
Electronic Signatures Poised For Growth
One area in which Freeman expects to see significant growth in 2015 is the use of electronic signatures. Today there are documents that many companies still prefer to retain on paper. This includes the FDA form 1572 (Statement of Investigator), the protocol signature page, and other site-based documents. Although electronic signatures are becoming more widely used, many companies are still not set up to allow electronic signatures to be used by the multitudes. Although companies are using electronic signatures, they are predominantly used within a certain department. In a small space, they are easy to use and manage. However, when you look at the clinical space and the hundreds of study sites that may exist in a single trial, the number of people at those sites signing documents suddenly seems like an electronic signature nightmare.
|Sandra Freeman, Senior Director of Customer Success, goBalto|
“Suddenly we’re talking about thousands of people as well as required training and different systems,” says Freeman. “When faced with that kind of a challenge, many companies will suddenly be hesitant about adopting. As a result, they continue to manage large volumes of paper. If you have a 500 site study and you have five wet ink documents to start, you already have 2,500 pieces of paper to deal with. That can be a pretty daunting task.”
As technology continues to progress, the electronic solutions for managing paper will also continue to get better. Freeman notes as systems get better at documenting and providing audit trails, paper will stay at the various sites while certified copies will be accepted through electronic means in a secure space. The ability to provide audit trails, time and date stamps, and version control are all improving. Eventually these solutions will catch on with more and more companies and gain greater mainstream acceptance.
In addition to the conservative and risk-averse nature of pharma, there also seems to be a lot of urban legends going around that have some compliance folks spooked. Freeman has heard the stories about FDA inspectors showing up at companies and requesting to review piles of paper. Whether those stories are true or not, they still have a lot of folks concerned and reluctant to go completely electronic.
Luckily, that fear factor is significantly diminished in younger employees who see electronic solutions making sense from a cost, storage, and environmental standpoint. “These trends will almost require people to change, and I can see it picking up more and more each year,” says Freeman. “Even within industry groups like TransCelerate there is a lot of conversation around embracing technology and reducing the amount of paper in trials.”
The Cost Savings Add Up
If companies move ahead with electronic solutions including portals and cloud-based applications to exchange documents, the industry may actually even see the first paperless trials. Freeman believes as documents are stored and managed electronically companies should realize average savings of over $100,000 per study. She also believes we will continue to see the increased use of analytics as well. IT spending for analytics increased by 51% in 2014, and this trend should continue in 2015 with the industry’s desire to better identify patterns and deviations in data and improve site performance.
There will also be an increased focus on study startups, an area where goBalto is focused. Study startup is one of the most paper driven processes. It is fast paced, there are a lot of handoffs, and there is a good deal of regulatory oversight as well. In 2015 sponsors and CROs are expected to follow the software industry and leverage lean startup principals to monitor operational performance and make improvements. This should result in reduced costs and improved efficiencies.
On average, Phase 2 to Phase 4 studies have 82 sites per study which average 17 months to get from protocol approval to 100% site approval. With a cost of $1,500 per month to initiate a site, it could cost $25,000 to complete all activities required to get just one site up and running. Do the math and you’ll find that study startup costs over $2 million. Reducing the time it takes to launch a study is critical to increasing the bottom line.
Freeman ended the discussion by sharing five suggestions for pharma and CROs to shave time and cost from the study startup process.
1. Optimize Your Processes: Make the most of cumulative learning from industry best practices and look at ways to standardize global operations.
2. Collaborate with sites and study teams: When everyone on the team has a transparent means to assess the real time status of documents and submissions, site responsiveness is accelerated.
3. Exchange Files: Make sure any solution you use includes the ability to instantly share files between sites. This will also have the added benefit of getting important documents out of email inboxes.
4. Track Activities In Real Time: Doing so will allow users to quickly identify issues and resolve bottlenecks.
5. Use Reliable Analytics: Spreadsheets do not have the ability to link critical data. This creates a void when it comes to visualization of data and impacts decision making. Using robust systems that can not only collect data but also provide a level of analytics will allow the team to make better decisions more efficiently.