Clinical Research Organizations (CROs) must track expenditures across multiple phases of R&D trials, secure contracts and follow strict compliance requirements—all while overseeing patient billing and sponsorship claims. With so much complexity, it’s easy for clinical trials to go over budget.
Only 1 in 10 drugs make it through clinical trials, and it takes an average of $985 million to bring a single drug to market. With hundreds of millions of dollars on the line, optimizing your revenue in clinical trials is crucial. Unfortunately, this is easier said than done and requires better accounting, documentation, and visibility.
Tracking billing and expenditures with notepads and Excel spreadsheets isn’t enough to meet client needs and auditing regulations. Instead, you need a powerful software solution to keep up with documentation and billing in real time. With the right technology, your organization can overcome common challenges, improve profitability, and to the customer experience.
What Common Revenue Challenges Do CROs Face?
Clinical trials are costly; there’s no way around it. Studies show that, on average, a phase one trial costs $4 million, phase two costs $13 million, and phase three costs $20 million. Phase four trial costs vary widely, with Genitourinary System trials averaging $6.8 million and Respiratory System trials averaging $115.3 million. It can cost upwards of $1 billion to successfully bring a drug to market.
The Society of Clinical Research Associates (SOCRA) identified seven common areas of revenue risk Clinical and Contract Research Organizations face. They include:
- Not doing a coverage analysis and proper budget
- Not identifying, registering, scheduling or tracking patients using IT tools
- Not segregating charges appropriately
- Inadequate budgeting, pricing and contracting
- IRB consent language not stating the intent for financial liability to the patient
- Poor or a lack of medical necessity documentation
- Incorrect charge capture or inaccurate claims submissions
Most of these issues come from an organization’s inability to plan and keep accurate records. However, if CROs operate more efficiently, they can overcome these common challenges and increase revenue.
While technology offers the most significant opportunity to do this, many businesses still cling to old, outdated systems.
For instance, many CROs use QuickBooks and Excel to track expenditures, deliverables and invoicing. Unfortunately, manually inputting figures into these systems is tedious and time-consuming. To make matters worse, documents in QuickBooks and Excel don’t sync to surrounding systems, so teams have to send emails back and forth with every change.
Relying on outdated technology to run your business will only lead to headaches. That’s why Enterprise Resource Planning (ERP) software like NetSuite is a game-changer. SuiteSuccess for CROs, built on NetSuite, tracks bills, invoices and other data in real time while providing a comprehensive audit trail and providing a single version of truth in a centralized database. With an ERP and Professional Services Automation (PSA) solution customized to fit your organization, you can remove roadblocks and optimize revenue.
5 Ways Technology Enhances Clinical Trial Revenue
Technology is crucial to a project’s success—through the business development and estimating cycle to securing a contract to final follow-up. Without the right tools, your effectiveness (and profitability) will suffer. Sikich’s SuiteSuccess for CROs, powered by NetSuite, improves project success by simplifying workflows, improving operational insight, and enhancing documentation. With this solution, you can be more effective and attractive to clients.
Securing a Contract
Sponsors are picky about who they give contracts to; they want to work with CROs that are organized, efficient and reliable. To accomplish this, you need a software solution to improve your documentation. The solution provides a self-service portal where sponsors can check the status of work in real time.
To meet expectations, you also need a more streamlined billing process. A solution like SuiteSuccess for CROs ensures that documentation is consistent across departments, so your clients won’t have to deal with late or inaccurate invoices. You also need flexibility to manage diverse billing scenarios due to contract differences.
Coverage Analysis and Budgeting
To stay on track during your project (and maintain healthy relationships with your clients), you need an in-depth coverage analysis and budget. Your plan should include an overview of your expected timeline, resources and funding, so clients know what to expect from the beginning.
As SOCRA author Kelly Willenberg says, “Going back and retrospectively building a coverage analysis is a huge job, especially if patients are already enrolled in the study and have been treated and the budget and contract have been finalized.”
Developing a concrete plan is essential to optimizing trial revenue. In addition to planning the project, you need to staff the study with resources with the right skills and availability to meet your project needs. ERP solutions like SuiteSuccess for CROs provide analytical insights and estimates so you can create a more accurate document from the start.
Charge Capture and Billing
Going over budget isn’t just bad for your clients; it can also harm your chances of securing future contracts. Billing for clinical trials can be tricky, especially in later phases when patients are involved. Your team must understand what your client will and will not cover as part of the clinical trial and bill patients accordingly. Unfortunately, inaccurate charge capture and billing can harm patient retention and result in sponsors overpaying for resources and clinic visits.
In addition, you need a system that can incorporate change orders, which are inevitable given the length and complexity of studies. Managing change orders effectively aids in preventing billing for charges that are not in scope.
An ERP customized to your industry can help you avoid imprecise charges and billing by improving documentation and unifying data between departments. This allows your teams to keep track of guidelines and double-check charges before submitting a bill. A solution like SuiteSuccess for CROs will also provide an overview of every action taken within each project, so you can quickly find errors and correct them.
Compliance
Life sciences companies must follow stringent compliance guidelines. These requirements involve everything from finance documentation to human resources management. In the face of ever-changing regulations, CROs must have robust auditing and tracking tools to avoid fines and penalties.
NetSuite can help you meet compliance goals by improving visibility and documentation. For example, the SuiteSuccess auditing tool allows CROs to generate accurate, concise reports within NetSuite. Because these reports are easier to read than traditional Excel spreadsheets, this functionality improves the auditing process and ensures your organization complies with government standards. This supports better investor relations. And for CROs that want to engage in the private equity and acquisition markets, auditable financials are a must.
Maintaining compliance improves operations and eliminates unnecessary fines—enhancing your business’s public image and long-term revenue.
Follow-Up and Patient Retention
Poor patient retention can turn a clinical trial on its head. To successfully bring a drug or other medical innovation to market, you need patient data from before, during and after the testing period. For example, if a patient undergoes treatment for six months and then drops out before you can follow up with them, you won’t have sufficient information on the drug’s aftereffects. Without the right data, it’s back to square one.
With real-time insights from clinicians, you can see how the patient is doing and get a pulse on their morale. With these insights, you can see if a patient is at risk of leaving and step in early to encourage them.
SuiteSuccess for CROs consolidates reporting for global operations, multiple service lines, study profitability department results and more—all in real time.
Technology shouldn’t create bottlenecks. It should remove them so you can optimize revenue by turning your business into an efficient, data-driven organization. To learn more about Sikich’s SuiteSuccess for CROs, contact one of our industry experts and schedule a consultation.
