As the design and execution of clinical trials become ever more intricate and complex, the cost of clinical trials continues to rise exponentially. The manpower and resources it takes to complete many of these processes manually add up to an onerous toll on the industry. Outsourcing models that were once the standard are now burdensome and antiquated. With more of the latest innovations making its presence felt in the industry, what new platform has the potential to disrupt clinical trials as we know it?
CTA Editor Henry Kerali speaks to Anca Copaescu, who is the Founder and CEO of Strategikon Pharma. For the past 15 years, she has amassed experience on both sides of the aisle working for trial sponsors and CROs. Having been on the frontline of clinical trials, Copaescu has witnessed first-hand the inefficiencies of clinical trials. Which is why she created the Clinical Maestro.
Clinical Maestro is a new technology that digitizes the essential functions of clinical outsourcing, including processes such as:
- Creating study plans, budgets and examine complex scenarios
- Generating RFPs and comparing proposals
- Tracking actuals and accruals, while managing contracts, from bids to final invoice
In the latest Industry Viewpoint, Copaescu sheds light on her company’s new product, while discussing the challenges associated with outsourcing clinical trials.
Henry Kerali: What are some of the unique challenges facing the industry that prompted Clinical Maestro to be developed?
Anca Copaescu: When I first conceived of Maestro, I thought of it as a labor of love and frustration. Throughout the years, I have seen a massive increase in outsourcing. It used to be a blend between pharmaceutical companies conducting clinical trials and subcontracting portions of work to CROs. Now, the landscape is drastically different.
Looking at the market numbers, 75-80 percent of clinical trials are now outsourced, which is a huge number. On one hand, this is good news for the outsourcing market as it shows the industry has matured over the years. However, the business processes associated with outsourcing have remained mostly the same, missing the opportunities to scale and improve efficiency.
HK: Could you elaborate on that?
AC: We are still in an age where there is little standardization in outsourcing tasks and activities. For instance, there are no standard Request for Proposal (RFP) templates and the contracts are managed largely manually. Running outsourcing departments, such as I did in my former role, necessitates a huge effort that everyone in the industry will recognize. Even after you have outsourced your trial successfully, tracking Excel- or PDF-based contracts over the course of a years-long study is a daunting task.
And this is not a problem solely faced by the sponsor side – CROs face similar challenges. Not being able to work in a standardized fashion, CROs are presented with different reporting requirements and a different set of tasks for almost every sponsor they work with. Additionally, the increased need for oversight coming from regulatory bodies to internal and external stakeholders, is prompting sponsors for more sophisticated reporting, and more metrics to measure performance. And this is all done manually – which is incredible considering we live in an age of easy communication – and yet the industry persists with what are antiquated processes.
In my experience, there is considerable frustration from both sponsors and CROs. From a privileged position of experience in both camps, I asked what we could do to become better at these critically important tasks. After scouring the market, I just wasn’t able to find what I needed and that prompted me to create Clinical Maestro.
HK: How does Clinical Maestro simplify processes for both the sponsor and the CRO?
AC: The entire software platform was designed with the end users in mind, hence, there are two editions – one for the sponsor and one for the vendor. Before any outsourcing is done, it’s critically important to have a robust plan in place. A stronger plan reduces the likelihood of protocol amendments and change orders.
Clinical Maestro starts with a planning module that is collaborative in nature, allowing the sponsor to run any number of scenarios with possible outcomes. Using the current processes and legacy technology, developing a study plan typically take weeks and requires multiple resources. The embedded intelligence in the Clinical Maestro platform creates an efficient workflow that can yield a plan in less than 10 minutes. Usually, the budgeting of a study happens way before it is outsourced as sponsors need internal approval for the necessary funds. Once you have a solid study plan in place, Clinical Maestro generates a matching budget before creating your RFP(s).
Once the clinical study plan is complete, Clinical Maestro takes the preferred baseline plan and seamlessly converts into a RFP. The system RFP template offers a wealth a pre-defined questions and selection criteria, representative of industry best practices. All the outsourcing professional needs to do is to select the preferred questions, or create new, by simply reconfiguring the system template. The RFP automation is huge because an enormous amount of time is spent qualifying potential providers (e.g. How years’ experience do you have in this therapeutic area?) It’s extremely laborious to conduct these kinds of assessments when you work in Excel and Word. Oftentimes, the knowledge is lost between different study teams, or due to internal staff changes. Furthermore, the same vendor qualification questions may be repeatedly asked over time, without having an intuitive and user-friendly way to actually check previous answers. The result is considerable time and effort savings both for the sponsor, who now has an intelligent provider qualification database, and the CROs, who don’t have to spend precious resources re-answering the same qualification questions.
HK: What has been the hardest part about developing Clinical Maestro?
AC: Maestro is the first attempt to digitize these processes end-to-end, and that has been the biggest challenge. There are no standards in this industry – every company calls the same activity something else. It can be very challenging to work in this space, for example, one sponsor’s bid grid may have a set of tasks that are exactly the same as that of another sponsor, but the tasks are named differently. Therefore, transparent comparisons and true assessments of effort and cost are difficult to achieve. Maestro can act as a translator between the traditional sponsor bid grids and the internal CRO proposal systems and ultimately may become the standard, as CROs may leverage Maestro to actually develop proposals in the system’s “native” language. The goal is that the platform will help bridge the gap between sponsor and CROs by enabling more real-time collaboration and process efficiencies.
HK: In an industry that is accepted to be slow adopters of change, do you think getting Maestro to be widely used is in a sense half the battle?
AC: I have worked in this industry a long time, so I don’t expect Maestro to immediately gain widespread adoption. However, it’s so transformative in nature that I am confident that a number of innovative companies will give it a try. Once they do so, it will be impossible to go back. Whereas before we sent faxes, now we send emails, or even texts. Before we had VHS, then we had DVDs and now people stream online. Word, Excel and paper (or pdf) RFPs are simply outdated in this day and age. There just hasn’t been a good way to replace them until now.
If you look at other technology changes in the industry, taking electronic data capture (EDC) as a case in point, EDC marked a huge paradigmatic shift. There was no turning back from the paper case report form to EDC, and that took only five to 10 years for that line of product to mature. With electronic trial master files, it took far less time for wide adoption. So it’s possible to affect systematic change, even if it takes some time.
Digital transformation promises to transform R&D productivity over the next decade. Clinical Maestro is one of the ways we can help our industry realize this potential.
*At Strategikon Pharma we believe complete transparency and effective communication, facilitated by intuitive technology, will revolutionize clinical research operations within biopharmaceutical companies, and with external collaborators. Clinical Maestro™ transforms processes for long-range planning, budgeting, procurement, contracting and vendor management with an end-to-end platform specifically created to support these functions. The result is unprecedented speed, precision and visibility that increases the efficiency and lowers the cost of running clinical trials. For more information, please visit www.strategikonpharma.com.