Early Adoption of New Technology in Study Startup – When is the Right Time?

The longer a firm is successful, the more complacent and vulnerable it becomes, and the more likely it is stuck preserving and protecting what it did in the past. Most organizations are dynamically conservative, they actively try to preserve core competencies instead of anticipating environmental shifts. Instead of assessing their surroundings and building unique capabilities, they resist change and remain focused on protecting what they are good at.

This proves to be a significant issue for companies when it comes to the development of new technologies in today’s world. If companies rest on their laurels, they may be eclipsed by early adopters of technology and struggle to regain market share in the future. If companies adopt too soon, they wind up investing significant capital and efforts in an immature and unusable solution. The question then becomes: when is the right time to adopt a new technology?

Embracing Uncertainty

Great organizations embrace uncertainty. They are constantly assessing opportunity and performance gaps to ensure market demands are met, and that they remain at the forefront of service. They identify what they do well, but also keep an eye on potential environmental changes that may lead to future opportunities and increased market share. Diagnosing the shifting environment and seeing the next best thing really requires strong corporate vision and a skilled workforce.

As PSI looked to increase our market share in new and longstanding therapeutic areas, it was imperative we ensured compress timelines with precise and rapid site identification of only the highest performing sites. While PSI has years of successful trials under our belts and has assisted with bringing many new drugs to market, we are continually looking to keep client satisfaction high and ensure faster study startup timelines. Rather than allow our competition to drive our organizational needs we chose to make some strategic decisions recently that will allow for more depth-in breadth with regards to market intelligence, site selection, and site activations. Executive management recognized that a lack of flexibility comes at a cost of missed opportunities and partnered with goBalto. goBalto, an innovative SaaS technology provider specializing in study startup software, had insight unparalleled by their competitors. Their vision was clear as was their commitment to their customers.  

Overcoming Inherent Obstacles

This decision didn’t come lightly. PSI has been a highly successful CRO for over 22 years and overturning longstanding organization policy required that we do our homework and ensure we moved in the correct direction instead of depleting resources and chasing false claims. Factors such as risk tolerance, bias, and the reliability of data and data sources all came into play. We needed to take time to ensure we arrived at the precise decision that would lead to enhanced business processes, rapid site selections/activations, and most of all on-time trial completion.

PSI chose to focus efforts on the decision-making process as they related to our organizational goals. First, we had to define some of the organizational goals of adopting a new technology such as goBalto.

organizational goals

 

Next, we had to run through the decision-making process. When making strategic decisions, one of the first things an organization needs to recognize is the degree of urgency in a situation. We're used to thinking of situations as urgent only when they're presented as such, but the degree urgency should be decided internally.

While every facet of clinical trials is important, study startup is in need of urgent attention globally, with 40% of sponsors unsatisfied with current start-up practices and targeted therapies shrinking potential trial patient populations, and according to Tufts CSDD “a 10% reduction in cycle times could attribute to an overall study cost reduction of $250 million”. If our adoption of new technology leads to such a reduction of timelines, then clients and patients alike would benefit.

To move forward with a new untested technology, however, would have been a critical mistake. “Just because the competition is doing it” is never a good reason. An adequate review of the technology had to be addressed prior to an enterprise implementation. We initially thought it best to address this via a pilot program, in order to test the system’s capabilities and either prove or disprove the service provider’s claims. With this quantity of money on the line and our reputation in the balance, it was imperative we collect data before moving in any direction.

Assessing Our Options

While looking for a platform, PSI assessed multiple vendors and eventually decided upon goBalto as our preferred choice. After implementing a pilot program, we were left with a difficult decision. Should we implement the full adoption of the entire suite of services, or instead go with a partial adoption of only certain aspects?

After seeing the depth and breadth of the Select and Activate systems, the evidence was clear. We must “go where the game is going, and not where we are currently playing.” Clinical Trial Sites needed a more transparent and smoother process in relation to being contacted and managing workflows with a CRO. As part of our strategic decision-making process, a candid assessment or diagnosis of current state was critical to determining the needed functionality of new technology.

While diagnosing our current state, it was obvious that the potential categories for change included three areas: People, Processes, and Technology. As PSI has recently been ranked the No. 1 Global CRO by a CenterWatch Investigator Survey in 2015 and again in 2017, it was our contention that our people were not the issue; instead there might be a way to enhance our processes and technology for working with sites in a more site-centric fashion by adopting the goBalto platform.

Such a decision to utilize an external vendor was not without risk for PSI though. In our 22-year history, we have never outsourced a vendor for such critical work, but we realized that if the service was subpar, we could divest immediately. But, if the service was excellent we could ramp up as necessary. This flexibility made risk more attractive. The balance between risk and reward is a consideration whenever uncontrollable factors are involved in a decision. Whether your natural inclination is toward risk-taking or minimizing risk, your decision making can benefit from a rational approach to risk. Once you've identified attributes of each alternative, you can consider the upside and downside risk associated with each attribute. As you consider the potential risks and benefits, you need to keep in mind how a positive or negative result for the attribute will affect value.

Risk factors included but were not limited to project delays, training and resourcing issues, lost time and money. Potential benefits included: greater site satisfaction, reduced cycle times and more targeted site selection. “The end results of the improved site selection is more predictable and faster enrollment,” says Kirill Soldatov, Director of Process improvement at PSI, “which then means more predictable and faster overall timelines.”

At this point in your decision-making deliberation, you have maximized your alternatives, analyzed them to determine your best course of action, and account for the risk inherent in the range of possible outcomes. Now we were ready to make this decision. But our work was not over, since no decision stands in isolation, and being prepared to manage the consequences is equally as important.  

Implementation of both platforms has been underway since the third and fourth quarters of 2017. Initial results for Select have been positive. PSI is identifying new sites to present clinical trials and strengthening our position in several regions. Since the US represents approximately 36% of worldwide clinical research sites (Citeline 2018) or about 120,960 clinical research sites, we are hoping to see significant growth in this region of the next year.

“We want to do more work throughout the startup phase than we do now, but with the same size of the workforce.  And we would like to take it for granted that this will be accompanied by a higher quality and transparency of our work combined with reduced operational risks,” Andrey Kozhemyakin.

Knowing such a large market can be difficult as it is constantly evolving. A great site today will soon be inundated with many new trials and eventually will be a victim of its own success and relegated to the mediocre site tomorrow. Since PSI is committed to remaining on the cutting edge of new site identification, the Select platform provides the ability to stack rank sites: capabilities, performance history, and therapeutic experience.

Expect to see a follow-up article in the next few months. With regards to goBalto Active, this platform has already been well developed over the last few years and adopted by several large CROs and client companies. Our experience with this platform is in its infancy currently, but the outlook is bright.

“As clinical trials grow in complexity, so do risk-based challenges to bring new therapies to market at an ever-increasing pace. The continued reliance on Excel for managing clinical operations, which lacks project- and risk-management functionality, has created an illusion of safety often fueling the rescue study industry,” said Jae Chung, President, and Founder of goBalto. “Discontent with the ‘status quo’ is driving forward-thinking organizations to embrace technologies that are finally moving the needle.”

“Automation has become critical to reducing the costs and complexities of clinical trials. However, it is not a panacea; rather it’s a catalyst to providing the operational transparency needed to drive insights, empowering business intelligence, process optimization, and efficient resource allocation, thereby improving proactive planning and highlighting entrenched bottlenecks in study startup.”

Onward to the Future

Early adoption of new technology can be a very slippery slope if it is not carefully assessed and vetted. Finding the precise right time may be more of an art than a science. Adopting too soon will not produce positive results while holding out too long will certainly give your competition the advantage of developing new market segments. Organizations must clearly outline their organizational objects, create a strategic decision-making action plan, ensure accountabilities and responsibilities and, lastly, ensure a robust integration plan.

We hope there was some value about how our organization progressed through the process and welcome any feedback. We are looking to a very strong 2018 through our adoption of new technology. 

by Jared Hager

 Jared Hager is Study Startup Manager, North America, PSI CRO. Before joining the world of clinical research, he worked as a paramedic for several years treating various medical and traumatic emergencies. He found the clinical research industry during this work and found it was an ideal platform to help patients in need on a much larger scale. With over 12 years in clinical research and more than 50 trials under his belt, Jared has worked on a myriad of therapeutic indications.