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TMF Expert Insights
Monday, March 14, 2022 | 12:44 PM
Scientific research combined with patient safety, regulatory compliance, administration and oversight, and collaboration between entities (sites, CROs, IRBs/ECs, central labs, etc.) creates quite an intricate network of activities and accountabilities. Sponsors introduce technology to navigate this tangled web as it has become entirely unsustainable to do so with paper and manual Excel trackers. Fortunately, eClinical innovation has advanced to the point that all of the essential processes of a clinical trial are accounted for and it is possible to not only digitize but also automate parts of day-to-day operations.
That said, introducing technology is introducing change. Going back to the topic of complexity, change introduces some of its own. At TransPerfect, we assert that complexity is the enemy of breakthrough therapeutics because, while complexity is necessary for the advancement of safe, trustworthy clinical research, it can also delay or disrupt innovation if an organization is not equipped to navigate it.
Technology is supposed to be here to save the day! However, much like how downloading a fitness app doesn’t magically give you muscles, onboarding technology does not magically manifest with seamless operations. Every organization is unique, with different strengths and weaknesses. If you’re an emerging or growing pharma, biotech, or medical device company, like any growing organization, you will not necessarily have the numbers to scale sufficiently and tackle every challenge, or you may not have every type of expertise required to sufficiently address every scenario. Those are the “good problems” of success!
As it relates to technology and change, there are some common gaps that emerge. These gaps can open an organization up to risks, delays, and unforeseen costs. The latter can be compounded when a sponsor has selected a vendor that does not fully support all of these common gaps and is forced to add additional vendors, which not only incurs more expense but also adds complexity, rather than controlling it, by now creating new oversight and management considerations.
Avoid getting caught by surprise and watching the cost of your technology investments creep ever higher via bolted on services from various vendors. Seek a tech partnership by ensuring your eClinical platform includes white glove solutions for the following seven considerations to help you control complexity:
For the most part, pharma, biotech, and medical device organizations all have their own twists on the processes required to run clinical operations. While many systems boast out-of-the-box configurations, companies rarely settle for that option as they want to capture important business requirements unique to their operating model and vision for success. Additionally, emerging sponsors typically do not have the IT staff or backend system experts to manage implementation independently. Successful change is about adopting new strategies while also preserving components that make up the “special sauce” of your company. In some cases, full implementation support comes at a premium and is often outsourced to third-party consultants. In most cases, implementation is a slow process that can drag on for months. Effective implementation support is an often hidden cost of ownership that adds service fees and weeks to your timeline (various estimates of the cost per day of a study hover around $100k/day). Implementation should be included in the cost of ownership. The vendor should have a track record of rolling out systems in weeks rather than months. The vendor should have references supporting their ability to successfully configure the technology to the precise business requirements of the study team. Lastly, the vendor should have obvious in-house, on-the-ground expertise in clinical operations. Your solutions should be implemented for you by someone who gets you and your type of organization.
Validation can often be a hiccup in what should be a simple process to adopt new technology. Teams may plan to validate a system themselves but run into bandwidth problems, or they may not have the staff for it at all. Again, this can ultimately become a hidden cost and a blocker for progress, and it is required by regulatory agencies.
Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records […] All production and/or quality system software, even if purchased off-the-shelf, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use.” - FDA
Your technology partner should offer this [DVO1] during the purchasing process to ensure you are able to easily verify your GxP compliance. Again, this service is often outsourced or added on after the fact, and it can impact your speed and your budget. Failure to sufficiently validate can also lead to future inspection findings. This consideration is tied very closely with implementation; it is easier for an organization with both implementation and quality teams to provide a seamless workstream from implementation to system validation without adding additional communication and collaboration complexity introduced by third-party vendors.
This consideration seems like a no-brainer, and yet so many providers fail to offer responsive, proactive support once the technology goes live. There are some important considerations for technical support. First, support needs to be at the ready at all times—24/7 and all 365 days of the year. Support also needs to be prepared to assist anywhere in the world, in any language. Support needs to respond quickly (within 24 hours) and work to resolve issues proactively, rather than allowing them to sit in a queue. The truth is very few vendors are actually global organizations prepared to operate at scale across continents and time zones and languages. When/if a need arises, this pain point can amount to the effect of “death by a thousand papercuts,” as simple support requests stack and slow operations. There needs to be a contractual commitment for support expectations so you know that your team will not be left waiting for help and watching the clock tick.
Introducing new technology fundamentally alters operating procedure. It’s not uncommon for emerging companies to be unfamiliar with or uncertain about best practices that will need to be codified into updated SOPs. For example, our team is often tapped specifically to direct the re-authoring of SOPs for CTMS use and TMF operations to align operating procedure and best practices with the eTMF. Again, these are the edges of change management where sponsors suddenly find themselves incurring unexpected consulting fees and adding more vendors. Guidance with successful technology onboarding and authoring new SOPs, among other strategic change management considerations, goes a long way toward enabling a successful digital strategy that controls complexity rather than amplifies it.
Aren’t SOPs operations? Yes. However, it’s important to delineate the strategic from the tactical. Strategic support, as mentioned above, deals with the overarching methods by which your organization will succeed. On the flip side, we have the actual, day-to-day activities on the ground. Very few technology providers are able to support you with things like TMF document processing, QC, migrations, and audits. Emerging pharma, biotech, and medical device companies—even the largest ones—frequently need to augment teams to ensure inspection readiness and mitigate the risk of inspection findings. This is another item at the edge of change management that can go overlooked and lead to additional vendors and inflating costs.
Sponsors and CROs with or without a squad of technologists benefit from assistance augmenting their teams, either to fill a gap in internal expertise or to simply avoid bandwidth strain and save time. Have you ever encountered a seemingly endless user manual and decided to close it? People need easy-to-consume information chunked into bite-sized segments. Job aides, tutorial videos, and the like created by staff trained in instructional design can have a huge impact on user adoption. These simplified guides reduce your reliance on your vendor and enable you to focus on more important tasks.
Beyond job aides, UAT (use acceptance testing) documentation, validation deliverables, and SOPs are additional business assets that can be created by technical writers. Technical writers already familiar with the technology can speed this process and deliver your documentation with predictable quality and vetted effectiveness.
With greater and greater emphasis on inclusion—such as ensuring research does not limit the populations who participate—as well as the general trend toward a more global approach, language is an important consideration for clinical research. It is also often an afterthought that presents unforeseen costs and delays down the road. Considering clinical research is so heavily document driven, it is important to think ahead and plan to translate/localize any documentation that may need to be presented in more than one language. Vendors typically do not have full-service in-house solutions for language. When a translation need comes up, the work is outsourced to third-party vendors. This brings not only cost but also quality into the equation. Ideally, document translations can be requested directly from within your eClinical platform, and the translation is handled by the very same provider and then seamlessly delivered back to the system quickly, accurately, and fully QCed in a regulatory compliant way.
Part of simplifying and streamlining your business is being mindful of all of the places where needs could arise that might require additional support. Having a strategy to reduce the number of chefs in the kitchen can help make things more manageable. Technology, in and of itself, does not solve problems. People do! In clinical research, there are numerous areas, like those discussed above, where people are necessary to perform specific critical tasks. When picking a technology partner, consider whether or not they can help you simplify your vendor strategy by providing solutions for many of the common needs that arise, such as implementation, validation, technical support, strategic support (like best practices and SOPs), operational support (like TMF document services), technical writing, and language services.