The Silicon Review
Clinical Operations is a crucial function for any company focused on the execution of clinical trials. A Clinical Business Operations team will generally be led by the Head of Clinical Operations and made up of roles such as R&D Outsourcing, Clinical Finance, Clinical Trial or Project Managers, and Vendor Management -- all of whom will work together to plan, budget, and accurately track trial progress and expenses to ensure financial and competitive goals are met. The clinical trials industry remains relatively healthy compared to many others, but COVID-19 and its impact are still causing a lot of disruption. It shouldn't take a virus to make us look at process breakthroughs where we need them most, but the pandemic has required us all to think beyond the way we've done things in the past.
As the world is scrambling to find a vaccine for COVID-19, it has become vital to provide clinical business operations teams with the ability to eliminate inefficiencies and move at lightning speed. Developing new medical treatments is a top priority for biotechnology and pharmaceutical organizations. Clinical Maestro digitizes the business processes and associated decision-making that is fundamental to execute faster and more efficiently. With 800+ standardized tasks, effort benchmarks blending both hours and resources, and timelines and billing rates for over 70 roles across more than 80 countries, Clinical Maestro replaces Excel and the aged point solutions process and data to provide business users with rich, actionable insights – faster.
In conversation with Anca Maria Copaescu, CEO of Clinical Maestro
Q. Has the Pandemic changed the way that Strategikon approaches the market?
We have essentially the same message now as we did before COVID-19. Before the Pandemic, everyone who looked at Clinical Maestro agreed it was a good idea. But humans can be creatures of habit, and change can be hard. Now that so many clinical trial professionals are faced with re-planning or reforecasting and restarting nearly all of their studies with budget timeline changes and protocol changes– both Sponsors and CROs are scrambling for solutions. We didn’t see it coming, but Clinical Maestro was practically built for this scenario. Organizations have found they can plan faster and more accurately, adapt to ongoing uncertainty with less pain and more flexibility, and manage outsourcing better with less effort.
Q. How is Strategikon looking at the changes that your customers are facing?
Since the start of the Pandemic, we have made it an internal mission to LISTEN to the customers, understand their pains and challenges. At first, we experienced the “crisis management” when all of the Sponsors’ efforts were centered around patient safety and trial continuity; the industry largely adapted to the new reality by mid-April, which was amazingly fast; this is the time when we experienced a spike in demand for clinical study reforecasting: essentially every study in our customer’s portfolio needed a “new scenario”; this intensive planning also fueled by the mid-year reforecasting, required tremendous effort by a handful of individuals which were also challenged by working remote. We saw Clinical Maestro power unleashed when the effort to create a study budget went down from tens and sometimes hundreds of hours in Excel to minutes, using reliable benchmarking. Finally, we have entered the age of “clinical study digital transformation.” We see the Sponsors and CROs look beyond the short- term needs into long term sustainable outcomes which can be best achieved through integrated technology. Clinical Maestro is well equipped to deliver on the promise of high efficiency through digitalization. Our PORTFOLIO™ application is equipped with the industry’s most advanced clinical study budgeting engine, which allows users to create a virtually unlimited number of clinical scenarios and compare the impact of changes across multiple aspects, such as timeline, cost, and resource allocation. For rapid study start-up and deep due diligence on new sourcing projects/RFPs and change orders, Clinical Maestro SOURCE™ is the first comprehensive procurement solution built from ground-up for clinical trial management. Finally, our latest application, LEAD™, is the first cloud-based clinical forecasting solution based on service provider reporting, which greatly advances accrual management and study financial progress tracking.
Q. Tell me more about the ‘combined team’?
At Clinical Maestro, we work in the clients in a multi-disciplinary way. Our Project Delivery team consists of highly trained industry experts (Delivery Leads), each having at least ten years of experience with both Sponsors and clinical service Providers in outsourcing, proposal management, clinical finance, and clinical operations. This team onboards customers but also serves as a “go-to” expert for any business or Clinical Maestro-related matters. We pride ourselves in personalized customer service delivery and high availability, and we are invested in our customers’ success. Especially now, during the Pandemic, we are finding that customers need the “speed” in delivery above everything else, which sometimes translates in wanting the answer, e.g. “a study budget scenario,” before learning the software. In response, we have launched new Clinical Maestro Services with multiple deliverables:
- Full Service Model: Delivery Leads take the study protocol and core assumptions, run the desired customer scenario(s) and provide the output to the customer, without having to train the customer on Clinical Maestro
- Operational Model: Delivery Leads serve as “in-house” experts to fill any gaps that customers may have, either in resources or expertise; for example, we can assist the end-to-end outsourcing process in Clinical Maestro, from creating an RFP to supporting bid due diligence.
Tell me – how is Strategikon doing since we last spoke?
I looked up "pandemic digital transformation" on Google and it returned "about" 79,100,000 results. Like for many other innovative technologies, the Pandemic has stimulated an urgency that has helped many organizations get past the consideration stage. Strategikon is coming off our best quarter ever:
Q. Do you have any final message for the clinical business professionals out there?
Memo to the Staff: A new approach to 2021 budgeting starts now. Your financial planning for 2021 presents an opportunity to turn new challenges and hard-earned lessons from the pandemic into an enduring return on value.
Anca Maria Copaescu, CEO of Clinical Maestro
Anca received her BSc in International Business from Academy of Economic Sciences in Bucharest Romania, an MBA from University of Pittsburgh Katz Business School and Czech Management School and an MSc in Applied Corporate Finance from University of Wisconsin Madison. Anca is the dynamo that powers Strategikon. She envisioned and created Clinical Maestro™ based on more than 15 years’ experience in the clinical research industry with both sponsors and service providers. Anca managed and advanced the company’s global outsourcing, vendor management and clinical analytics functions. At two of the top global clinical research organizations (CROs), PharmaNet Development Group (now inVentiv) and Icon plc. Anca drove strategic corporate development activities.