COVID-19 – A Wake Up Call for Global Healthcare and Life Sciences Companies
The numbers are staggering. At the time of writing, according to worldometer, there are over 803,126 cases of COVID-19 in 199 countries and territories, resulting in 39,032 deaths. COVID-19 has impacted every human being on the planet and devastated many businesses, particularly those in the airline and hospitality industries.
In time, we will have a full understanding of COVID-19’s origins. Early analysis suggests a transfer from bats to the human food supply – a clear demonstration of the fragility of the human genetic makeup and vulnerability to the mutation of existing and new viruses. If there is one learning we can take away from this episode, it’s that we need more global regulation around the human food supply chain.
As a race, we must rise to Mother Nature’s challenge. After all, she has been very effective at thinning the world’s population over the centuries. When we hear about an outbreak of Ebola across the globe, it is forgotten by the next day because it’s happening literally thousands of miles away. But when lines wrap around the grocery stores and there is a worldwide scarcity of toilet paper and hand sanitizers, the very real impact of a global health pandemic hits really close to home.
Now, more than ever, the Healthcare and Life Sciences industries are under the microscope of every human being, from world leaders to remote sharecroppers. Every day we hear about the impact on providers in the industry – widespread shortages of hospital beds, floating military hospital ships, hastily erected temporary hospitals, and city landmarks, such as the Jacobs Javits Convention Center in New York City, turning into makeshift facilities to care for the sick.
At the other end of the Healthcare value chain are the biopharma manufacturers and their Contract Research Organization (CRO) partners racing to produce and bring to market test kits, vaccines, and treatments to tackle COVID-19. It is here that we see the real impact of technology as it streamlines the processes and delivers a more agile drug creation process, maintaining the regulatory oversight required for such products to safeguard downstream patients.
From Testing to Production: The Need for Faster Solutions
One of the most challenging aspects of drug development is the number of processes, departments, and systems that must work in harmony to successfully execute an end-to-end clinical research program. The COVID-19 pandemic clearly indicates a worldwide problem that must be addressed on a global basis, from development centers to test subjects to disparate government regulations. This massive challenge for pharma companies is reflected in the cost of development and the subsequent price of the drug to the patient.
The business of clinical trials is driven by performance and milestone-based contracts. There are a multitude of contracts governing this process across sponsors and outsourced manufacturers, CROs, sites, investigators, laboratories, and logistics suppliers. Budgets, timelines, performance obligations, and payments are all incorporated into these contracts. It’s vital, then, that these contracts are established upfront and vetted correctly. Unsurprisingly, this aspect of clinical trials is expensive. Major drug companies spend over $10M annually to manage the resources and disparate, often proprietary systems that handle forecasting and contracting processes.
With clinical trial milestones contractually set, tracking progress against contractual obligations and timely reporting to regulatory bodies is another key challenge that drug developers face. With so many moving components and parties, it is critical to get near real-time visibility into study and contractual performance and ensure the overall project does not go off track, lead to subject drop off, cause invalidation of the trial phase, or incur cost overruns. Revenue leakage associated with lack of milestone progress visibility can run into the tens and hundreds of millions of dollars for large pharma manufacturers.
With development schedules measured in years rather than weeks, projects and the underlying elements often change during execution after an agreement has been established. A number of changes affect the myriad agreements, such as changes to budgets, timeframes, provider and investigator networks, and regulatory-driven changes. Amended quotes and agreements need to be coordinated, generated, and executed efficiently across all parties. Information needs to be rapidly passed on to downstream clinical trial management systems (CTMS), financial systems, and payment systems. The lack of robust quoting and contracting systems that can handle amendments at scale causes delays, which are again very costly.
Case Study: Alleviating Inefficiencies
Consider the experience of a well-known multi-billion pharmaceutical company that turned to Apttus’ integrated Configure Price Quote (CPQ) and Contract Lifecycle Management (CLM) solutions to alleviate major inefficiencies in their clinical trial processes.
Challenge: The company’s previous contract management process was very manual and the organization was exposed due to lack of visibility into compliance against contracted obligations. They required a solution that could scale across global users and drive efficiency at reduced costs across global participants and regulations. Its proprietary, incumbent contract management solution did not provide a single source of truth, which is essential to a process that relies heavily on geographically distributed participants.
Solution: Today, almost all clinical trials are global projects. The company needed a mature, global contract management solution that scaled beyond standard lifecycle management, handled complex industry needs such as budget and obligation management, and put cross-participant collaboration front and center before, during, and after contract execution to decrease cycle time, cut costs, and simplify every step of the process for all parties. The company selected Apttus to provide a single global contract repository that helped achieve the desired outcomes and ensure compliance with regulatory requirements.
It comes as no surprise that this biopharma manufacturer can now respond to the increased contracting demands imposed by the COVID-19 pandemic with great agility.
Integrated CPQ and CLM – A Clinical Trial Better Together Strategy
Many departments across an organization are called on to collaborate for clinical trials: sales, procurement, contract operations, pricing managers, finance, compliance managers, and, of course, scientists and clinicians. The extensive process involves vendor selection, budget and bid grid submission, multi-party contracts, regulatory compliance, study execution, milestone tracking, site aggregations, forecasting, and vendor performance management. This is probably one of the most complex and operationally challenging processes of any industry.
The seamless integration of a CPQ solution with a CLM solution that drives collaboration across parties is the only way to at least scale key upstream vendor, budget, proposal, and contract management processes and deliver the efficiency and agility needs that these unprecedented times demand. Apttus, backed by industry-leading AI technology, provides this level of integration to guide users across collaborating parties through the complex process while delivering accuracy and reducing cycle times and human error. It’s no wonder that many global pharmaceutical giants and CROs use Apttus for increased customer satisfaction with improved budget and quoting accuracy and contract compliance.
The World Woke Up and Change is Required
For decades scientists have been trying to educate world leaders, academics, and the general public of the risk of global pandemics. And, for the most part, their warnings have fallen on deaf ears. It’s clear the world is not ready to deal with a global pandemic on the scale and voracity of COVID-19. Let this be a wakeup call to all human beings and the governments that represent them. Measures must be installed to protect the human race from global pandemics. The Healthcare and Life Sciences organizations that we turn to during these times must be equipped with the technology and processes required to deal with outbreaks more quickly and efficiently while protecting the population.