In the last ten years, Sikich has been able to help a number of pharmaceutical companies and Clinical Research Organizations (CRO) build technology platforms that enable them to run and grow their businesses. While the two types of companies share some concerns and trends, CROs are probably more challenged and limited by the choices of software tools that are available to them.
CROs tend to be project-based companies, which adds a layer of complexity to business operations and the demands on technology. They are typically underserved by standard ERP solutions, which don’t quite meet their business needs even when they include project management capabilities. An additional factor is that many successful CROs grow quickly. Spreadsheets and entry-level business management systems from a CRO company’s earlier days can become limiting and inefficient quickly.
An industry challenged by technology islands
The Veeva 2017 Unified Clinical Operations Survey: Annual CRO Report highlights the industry’s main technology challenges and opportunities. Overall, the industry has increasingly adopted technology. Only 8 percent of the CROs still use trial master file (TMF) documents on paper – as recently as 2014, that was a practice followed by 47 percent. However, there hasn’t been a noticeable trend to deploy end-to-end project and business management systems. Most CROs today use an array of software solutions, including clinical trial management systems (CTMS), electronic data capture (EDC) products, and electronic trial master file (eTMF) solutions. We also find them often working with other, not integrated systems, including customer relationship management (CRM) solutions, project management tools, and financial and productivity software.
Given this digital fragmentation, it’s no surprise that consolidating and integrating technologies is a priority in the industry. 100 percent of the survey respondents state that they need to unify their clinical applications, and 72 percent say that integrating several applications is the main challenge they face. 54 percent express a need for better visibility and 50 percent note that their integration challenges limit their company’s ability to improve clinical operations. 30 percent, however, track clinical data outside of their main software systems, which brings a high likeliness of errors, inefficiencies, and poor visibility.
Focus on the critical business concerns and processes
When we meet with CROs, we often find that it’s more effective to start by addressing the business issues they face instead of focusing on technology integrations immediately. The CRO industry is extremely competitive; there is never a guarantee that you will have a repeat engagement with the same client even when you set a good precedent. In performing clinical research for their clients, CROs do their utmost to deliver top-quality projects at a competitive price.
Two aspects of the business are critical to most CROs in delivering successful, competitive projects. One is flexible billing and contract management, for example, switching back and forth between time-based and unit-based billing, which can repeatedly be required even on the same project. Flexible contract management, which directly impacts billing, needs to be able to address such questions as what to do with resources and materials that are unused at the end of a project. Are they, for example, to be kept for a new research study, is the client reimbursed for them, and can they transition to another client’s project? Second and just as important is timeliness – the ability to move through the entire bid-to-bill process faster and more efficiently than competitors can.
Technology, including the systems integrations that are top-of-mind, has to help CROs resolve these concerns. When the Sikich team works with CROs, we combine our industry expertise with proven, flexible technology tools that can be configured to meet CRO requirements. We usually begin with a business process engagement, where we review a CRO client’s current practices and propose best practice-based, streamlined process improvements. Sikich has developed a portfolio of standardized CRO processes for such business areas as bidding and sales, program and project management, and resource management. Our bid-to-bill process template supports the entire lifecycle of CRO projects.
A cloud infrastructure optimized for CROs
As the foundation of a CRO technology infrastructure, we often deploy for our clients NetSuite, a complete, cloud-based ERP and business management system. NetSuite is powerful, flexible, designed for ease-of-use, and does not present the complexities of larger ERP systems. It’s also backed by a solid roadmap for evolving an ever-better business platform. In the cloud, the solution can scale to any number and complexity of projects, in any location.
For the many fast-growing CROs that serve clients and perform projects in several global regions, information and software resources in the cloud are directly available to anybody who needs them. Executives and managers anywhere can perform planning and decision-making and manage the project portfolio and client relationships based on comprehensive, current business data in the cloud.
Once CRO clients see the advantages of standardized business processes on a consolidated business management platform in the cloud, integrations with specialized CRO software tools and other, smaller technology changes can sync with the overall strategy. What’s more, instead of IT spending time with everyday administrative tasks, CROs can give their IT teams a more strategic role in moving the business forward when they adopt cloud ERP. Server systems, data storage, networking, data protection, and other components of data center management are all provisioned and managed as part of the cloud subscription, which means those investments are no longer required.