Good Technology Practices: A New Challenge for Sites Now and in the Future
As we are living in an era when technology deeply inhabits our day-to-day world as well as our workplace, it seems logical to consider what changes in technological demands mean to our clinical research practices.
It occurred to me recently that as a site owner and investigator, in addition to Good Clinical Practices and Good Business Practices, perhaps it is time for us to consider developing GTPs—Good Technological Practices.
It is important to define and develop an understanding of the paradigm shift that will include electronic data capture (EDC), risk-based monitoring (RBM), more robust housing of site information and profiles in databases, use of portals, electronic signature requirements and new technological advances such as wearable devices for data capture—all of which will influence the practice of clinical research.
Also relevant is how a site prepares for GTPs so as not to fall behind in the advances and processes around the technology requirements to sustain and develop one’s business model. The classic management book, Good to Great: Why Some Companies Make the Leap...And Others Don’t, published in 2001, presents food for thought, as it discusses the business of addressing specific technology needs. Author Jim Collins presents an argument that how a company relates to technological change is a good indicator of its inner drive for greatness versus mediocrity. Great businesses respond with creativity and thoughtfulness driven by a compulsion to turn unrealized potential into results. Great companies use technology as an accelerator of momentum, not a creator of it.
Therefore, the key questions for sites are: What technologies are critical versus a fad, and what constitutes basic needs versus more complex elements of success?
What would be considered technology accelerators in the site realm? First and foremost, technology does not always equate to complex “high-tech solutions.” The needs of your business may be as simple as building technology or purchasing technology to support basic operations. At RAA, we have addressed processes as elemental as phone systems and email capability. We recently faced a dilemma in which our internet and phone services were not bundled, so we were dependent on the phone company to restore service if the system went down. We have since upgraded to VoiceOver Internet Protocol (VoIP), so if our landlines are down, calls can be routed to cell phones or answering services to avoid any interruption of service. In addition to reducing downtime, VoIP allows us to manage our phone and internet systems through one service provider, which makes the system less cumbersome.
Another example: the use of a Microsoft Office and on-site hosted server platform to manage files and data. We realized our pay-per-user file storage system was not as secure as it needed to be, and we could not afford to lose any critical files or data. It was necessary to ask ourselves how we could NOT afford to upgrade our systems. Our previous cloud-only technology now is backed up by our server, both remotely and on site, to avoid costly loss of information.
These basic examples point to the need to evaluate all technology that underpins your operations, both complex and more basic. Many sites make the investment in clinical trials management systems (CTMS) and either do not understand or do not fully use the technology available. Whether it is housing of records, confidentiality, privacy or clinical operations, technological acceleration will keep you ahead of the pack, while technology—if not maintained and evaluated regularly—will keep you stuck in a mom-and-pop culture.
Finally, a reminder for when we are tempted to ignore the small steps that mean big change: “good-to-great” companies think differently about technology than mediocre ones. They carefully assess their individuals’ needs focused solely on the needs of their business.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas.
This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »