Addressing Research Technology Challenges to Gain Sponsor Buy-in
At Advarra, we are passionate about enabling the industry to become more site-centric. To achieve this, it is especially important to equip sites with the proper technology to conduct studies. One way to do so is encouraging sites to seek buy-in from their sponsors as they advocate for using their preferred technology platforms on studies. Not only will this reduce the amount of technology platforms needed to conduct a study, it will also accelerate trial timelines, benefitting both sites and sponsors.
Benefits to Having Control Over Your eClinical Systems
Ultimately, since sites are the ones conducting research, they are responsible for the quality of items such as documents, consents, and data. With staff on the front line of clinical research, it’s only natural to want sites to have the best tools and technology available to enable them to produce their best work. Making it easiest for those on the front line will ultimately make any study more successful.
There are tangential benefits to making tasks such as collecting signatures, managing documents, or assisting in the startup process easiest for the staff conducting them. By letting staff use technology they are most familiar with, they can collect this information and complete tasks at a quicker rate. The trial will, in turn, cost less, have a shorter startup timeline, and give sponsors quality data and documents. Protocol deviations are expensive; empowering sites to do what they do best with fit-for-purpose technology will benefit all parties.
Common Challenges When Asking for Sponsor Buy-in
When trying to gain sponsor buy-in, there are several things a site can do before approaching their sponsor. It’s almost guaranteed their sponsor will ask if the system is compliant and validated. Outlining if the system is 21 CFR Part 11 compliant, where it will be hosted, and answering additional security questions before sites approach sponsors will save time on both ends.
Additionally, gathering basic materials beforehand and assembling them into a “frequently asked questions” package will benefit sites. This may include standard operating procedures (SOPs) or other material you think the sponsor may want to know. Just as they are doing their due diligence in asking these questions, you should be ready to answer their most common questions.
Advocating for Using Your Own Technology
Oftentimes, sponsors will come to sites with a specific technology platform for them to use, which typically does not align with the technology platform that site uses regularly. For example, a sponsor may mandate an eRegulatory (eReg) management system despite the fact that sites typically have their own already-implemented eReg system. Sites using a platform different from the one they regularly use or are familiar with may negatively impact the trial. Staff will first need to be trained on how to use the sponsor-mandated software, which can delay activation timelines. Additionally, staff will most likely need to input data into their site-preferred system as well. This duplicative data entry makes data errors more likely, and results in more time spent on a protocol than what is necessary.
Even if sponsors suggest specific technology, sites should feel comfortable pushing back if they have a different system they feel would be better suited for successfully conducting the trial. There are many reasons a site might want to consider advocating for using their own technology. Using their own technology allows a site to following already-documented workflows and SOPs, which in turn saves money for both the site and sponsor. The less time needed for training new systems in general will save time overall, resulting in an accelerated study activation and, ultimately, delivering life-changing treatments to market more efficiently.