Tag Archive for: Life Sciences

Business Expansion in the Digital Age

No business or industry has gone untouched by the widespread impact of COVID-19. Whether it was business development, talent acquisition, or company culture, every organization had to adapt in some way to weather the storm. In fact, many organizations were still reeling from the effects of the omicron variant just a few months ago in early 2022.

But now, as we look back on the past three years from the post-COVID era, there are many lessons to be learned and many opportunities to take advantage of as businesses seek to recover, grow, and thrive moving into the future.

Our industry and the industries we serve, for example, have faced several challenges over the past few years. From a business development perspective, there was a sudden reduction in trade shows and in-person events a few years ago, impacting our ability to make connections with customers and forcing our sales team to adapt virtually. On a larger scale, the life sciences industry as a whole is struggling with talent deficiencies and increasing costs, all of which impact outside partners like Pro-ficiency. Studies are harder to staff, sponsors are struggling with manpower, and business expenses are going up tremendously.

When we think about the strategies and tools businesses can use to make the most of this unique environment, a few things come to mind…

Focus on Customer Satisfaction and Innovation

Focusing on customer satisfaction and bringing innovative offerings to the table can mitigate gaps caused by a dip in new customer acquisition. In a world where business expenses are skyrocketing, sponsors/CROs are more than ever on the lookout for cost-cutting strategies. And at Pro-ficiency, we strive to provide such a valuable experience to customers that they always come back to us for their next study.

To ensure our customers’ satisfaction, we invest heavily in our technology and our team to provide customers with tools that provide undeniable value to their business. Most recently, we expanded our sales team, acquired a product development team for updating and creating new products more rapidly, and launched the use of avatars to help improve throughput and capacity for building simulations. We also have a whole series of product initiatives in the works to facilitate payments, improve analytics, and allow study participants to more easily connect – all expected to roll out in 2023.

By investing in the right priorities, we are able to deliver for our customers and make future acquisitions easier.

Embrace Virtual

Pro-ficiency has always been a lean and virtual organization, so we were well-positioned to tackle the pandemic from day one, needing to make much fewer adjustments than other larger businesses that operated primarily in person. Now that we are on the other side of the pandemic, it’s obvious that virtual is the way forward. For the sake of business development and company culture, embracing this reality has proven to be better at reducing costs, maintaining employee satisfaction, and delivering results than even the old pre-covid way of conducting business.

With the right tools and structure, employees can be much more efficient, product development can be streamlined, and building your team from a much larger pool of candidates can offer unlimited opportunities.

Invest in Company Culture

Building a meaningful company culture where a team can thrive is more important than ever as employees have unlimited options at their fingertips. Making this a top priority will pay off tenfold down the road as companies look to expand and grow.

At Pro-ficiency, we’ve been very fortunate to attract top-shelf talent. A lot of that is because people want to be involved in what we do. Being part of the solution to accelerate therapeutics for a rare disease is very noble work, it’s meaningful. We also work to create a positive day-to-day environment for our team by connecting personally with virtual tools, sending regular updates on company progress, and getting together in person whenever possible. All of these efforts go towards creating a culture that will allow Pro-ficiency to grow in this new world.

Overall, businesses that adapt to the new digital landscape and prioritize customer satisfaction, innovation, and company culture will be well-positioned to thrive in the post-COVID era.

Visit our website to learn more about Pro-ficiency: https://www.pro-ficiency.com/about/

Preemptive Protocol Analysis: Reducing the Need for Retraining

When things go wrong during a clinical trial, retraining of staff is often the go-to response to correct the problem. But rather than using training as a band-aid for every protocol deviation that occurs, organizations would be better served by investing up-front in protocol analysis to anticipate areas where protocol deviations or other problems are likely to occur, and then designing training that will trouble-shoot those issues in advance.

While staff retraining is the knee-jerk reaction to a protocol deviation or problem, training is not always the root problem. There could be issues with a site’s operational process, technology or communication, among other things.

If done properly, training can be designed that anticipates these potential problems and focuses its efforts on ensuring that challenging parts of a protocol are fully understood. This depends upon a thorough protocol review, with specific input from patients and research sites to identify anything that is unclear or impractical.

This information can then be used both to refine the protocol into something difficult to misinterpret and to develop a training program that truly meets site’s needs, along with job aids where it makes sense to support research staff in making the correct decisions with every patient and every procedure.

Correcting protocol deviations can be a costly and time-consuming process that leads to study delays, extra costs and potential impact on study data. And deviations are far from uncommon. According to a study published by Tufts Center for the Study of Drug Development (CSDD) last year, Phase 2 and 3 protocols have a mean of 75 and 119 protocol deviations, respectively. And the FDA’s most recent BIMO metrics report lists protocol deviations or failure to follow the investigational plan as the most common observations listed on Form 483s after a BIMO inspection.

But deviations aren’t the only issue of concern. Protocol amendments can add significantly to the cost and duration of a clinical trial. CSDD has estimated that a single protocol amendment to a typical Phase 3 protocol can add three months of time and more than $500,000 in cost to a clinical trial, on average.

And amendments are on the rise. CSDD data indicates that the frequency of protocol amendments is increasing. During the 2018-2020 period they increased significantly compared to the 2013-2015 period. Nearly 78% of Phase 2 and 69% of Phase 3 protocols had at least one substantial protocol amendment; total amendments per protocol averaged 2.7 for Phase 2 and 3.3 for Phase 3.

Both protocol deviations and amendments potentially impact patient retention, investigative site commitment and the completeness, accuracy and reliability of study data.

But none of this data means that protocol deviations and amendments are just part of doing business for the clinical research industry. Rather than the traditional reactive response to problems arising during study conduct, sponsors could take a more proactive approach and trouble-shoot problems before a trial even begins.

Communication, analysis, then training

And this does not begin with protocol training. The first step to avoiding deviations and amendments is a thorough analysis to understand what a day in the life of a patient or research site would look like under the protocol.

For instance, many logistical issues can become major pain points for research sites and patients when it comes to putting the written protocol into action. The time window required for drug administration or patient visits is one example. A protocol may provide a window of 10 minutes to administer a drug, but that window may not be workable for all sites. If a particular site has patient visits occurring on one side of a large campus while the research pharmacy is on the other side, for instance, that 10-minute period may be insufficient.

If a drug takes 45 minutes to thaw before being provided to a research nurse to administer, that will add to the time needed to prepare each dose for each patient. Further, if the pharmacy is at a distance from the clinic, the time to deliver that drug also must be considered. Other factors include the time needed for the nurse to prepare the patient and prepare the drug in an infusion bag. The whole process could take well over an hour.

Similarly, the amount of time and effort required to attend visits and otherwise participate in a clinical trial can have a big impact on patient willingness to enroll. Protocols that include lengthy visits for tests and treatment can put patients off, as can lengthy or frequent trips to the clinic. Remote visits may ease some of that resistance for some patients, but not all; some may be unwilling to have strangers coming to their homes.

And on the staff side, long or frequent visits can raise questions about when staff must be available.

In essence, a protocol analysis needs to consider what is practical for patients and for the sites that will be conducting the clinical trial. This sort of analysis requires input from both patient groups and the enrolling sites. While it’s becoming more common for sponsors to include patient advocacy groups input into protocol design, that is just the first step. They also need to get feedback from the sites that will implement the protocol to learn what is and is not operationally feasible.

With that operational input, including what parts of a protocol may be burdensome or impractical for patients and sites, a sponsor can refine its training to fully address any areas that might differ from a site’s normal standard of care or otherwise be open to interpretation.

Solutions such as Pro-ficiency’s Protocol Optimization methodology can be used to get a thorough interpretation of a protocol, identify potential problem areas or pain points and provide a visualization that helps make clear what the journey through a clinical trial will look like for patients and research sites.

The mapping out of tasks and timelines in the protocol is especially important. Without that visualization, it is easy to miss all the steps that have to happen with each procedure or patient visit. It also helps to uncover any inconsistencies that might exist in the protocol. A visual mapping of a study’s operational flow, on the other hand, will easily reveal any issues.

If that process flow is animated, as provided by Pro-ficiency’s Protocol Optimization solution, it can become even more clear. In essence, a sponsor can see in a few minutes the whole of the study experience for the sites and patients in a way that will have a visceral impact and better enable both refinement of the protocol and development of effective training.

By approaching protocol optimization in this way, sponsors can ensure that training reflects perfectly the experiences research staff will have in implementing a given protocol.

And this effect can be expanded by incorporating simulation-based training. Any novel or unusual procedures can be more carefully illustrated and explained to avoid misinterpretation; job aids can also be provided to guide researchers’ decision-making in real time. The training can likewise walk researchers through not only the steps, but the timelines needed to complete patient visits and other key tasks.

Training, in this way, becomes a tool for proactive troubleshooting, reducing the need for after-the-fact procedures to address protocol deviations.

To learn more, visit our Pro-Active Protocol webpage: https://www.pro-ficiency.com/protocol-optimization/