For many companies, implementing new clinical technologies can be a difficult endeavor. Compatibility issues, training, and employees who are resistant to change can make implementations a challenge. This is as true for CROs as it is for sponsor companies.
Many new technologies are designed to make trials more efficient, but implementation issues can cause confusion for patients and site staff, create difficulties for CROs and headaches for the heads of clinical operations who must often deal with the aftermath. One clinical executive recently told me she was getting tired of technologies that make her job more difficult, but seem to do nothing to bring needed innovation to trials. Simply implementing a new technology should never be the goal. Technology is a tool that enables us to achieve the actual goal, which is generating faster, less costly, and more patient-centric clinical trials.
As executive director for consulting firm Cirrus Clinical Services, Gary Gentry spends his time helping clients plan and implement new technology solutions to improve the efficiency of their clinical trials. He has been working as a consultant on technology solutions at the enterprise level for more than 17 years and has seen many implementations succeed while others fail. I recently spoke to him about this problem and what executives can do to better prepare for change when it comes to their companies.
Ed Miseta: What size companies do you currently work with?
Gary Gentry: We are focused on a couple of segments. There are the small- to mid-sized companies that often do not have deep in-house expertise to effectively operate clinical trials and may need guidance across a broad range of areas. But we’re also focused on the mid-sized to larger sponsors and service providers who are looking to take advantage of modern technology in more targeted ways to drive greater efficiencies and to help accelerate the execution of the trials they own or operate.
Miseta: Are there any technologies hitting the market that you think will have a significant impact in the clinical space?
Gentry: One area we’re excited about right now is around the opportunity to use technology to enable process automation in clinical trials, or what’s commonly referred to by the buzz term: Robotic Process Automation (RPA). We like to call our industry spin on this concept Clinical Trial Process Automation (or CTPA). The essence of the concept is very simple: utilize technology to automate any function that doesn’t really need to be performed by a person, and thereby increase the performance, consistency, and accuracy of that process. This also frees up human resources to focus on more valuable activities that only a human can do. If you think about a typical clinical trial, you have all of these disparate systems that require inputs and produce outputs, such as clinical trial management systems (CTMS), accounting systems, spreadsheets, document stores, etc. Employees working in those areas are dealing with these different systems, putting data into some and getting data out of others. This involves a lot of manual steps. In a nutshell, RPA (or CTPA) uses bots to automate routine steps, putting those processes in the cloud and allowing them to run more efficiently.
Miseta: Can you give an example of how this might work?
Gentry: Sure. Let’s say you have a standard process that requires a user to maintain certain information in a spreadsheet, or uses data generated from a report or from a web page in the CTMS. Usually, someone must do something with information like this, whether it’s updating an accounting system, initiating a payment, or issuing an invoice. More often than not, these types of intermediate steps are performed by humans. With RPA, we essentially configure automated bots to load spreadsheets or scan reports, or scrape a web page to capture data and automatically load the information into the systems that need it.
By automating whatever we can, we can be sure a task gets done the same way every time, that it is performed as soon as possible, and that it can be tracked and managed from one place. The steps are performed more quickly and without the risk of human error. Automation also increases quality, but not just by bots performing data integration steps the same way every time. There are also advantages to trial team members in that important data regarding quality metrics will be centrally accessible and analyzable so course correction can be addressed in near real time.
In clinical trials, this concept can be applied to many areas, including patient recruitment activities, site payments, start-up activities, and trial financials. There are many repetitious, laborious, and error-prone processes that can be streamlined and automated with this type of technology.
Miseta: Is this technology something that would be affordable to small pharma and biotech companies?
Gentry: Any organization can benefit from automation, but the business case and returns will vary based on an organization’s specific circumstances. There are many technologies that you can get into at almost any scale. With any automation solution, you generally find that greater scale means greater benefits. I would tend to look less at the size of the company and more at the number of manual processes performed. For a VP of clinical operations in a small company, what is the value of their time? That is what we are saving by automating many of their manual tasks.
There are also different levels of automation. On one end of the scale you are simply replacing a rote manual process with a bot that does the exact same thing, only faster and more consistently. On the other end you’re taking advantage of more advanced concepts such as machine learning, where you apply intelligence to the automation so that it is more effective and improves over time as more data is analyzed. Obviously, simpler programs generally require less investment. Of course, affordability can be measured in different ways and one of the most common mistakes I’ve seen in my career is an inordinate focus on the up-front hard costs of executing a project. While this is clearly an important consideration, what’s most important is to start with a clear vision of the end business goals, define quantifiable objectives in advance, and plan up front for how you’re going to measure results against your objectives. A lot of that sounds obvious and trite, but I have seen inordinate sums of money spent executing programs that did not have a clear business objective, or were initiated because an organization felt pressure to be using some new technology. Those projects almost always fail. Good information technology adds value to the core business in specific and ideally very measurable ways; it has no value in and of itself.
In part 2 of this article, Gentry will explore what companies need to do to make their next installation a success.
Come hear Gary Gentry speak about technology adoption at Clinical Leader Forum, May 9-10, 2018 in Philadelphia. Click here for details.