According to the Veeva 2017 Unified Clinical Operations Survey: Annual CRO Report, an industry trend to increased outsourcing also drives a greater need for effective collaboration between contract research organizations (CRO) and their clients. Close to a quarter of surveyed CROs state that limited collaborative capabilities in their current clinical trial management system pose a challenge for them. Thirty-three percent of the potential clients and sponsors agree.
When the respondents were asked how they exchange trial master file (TMF) documents among CROs and their clients, 54% of the CROs said they use email. That is a marked change from the 2014 survey, when email use for sharing TMF documents was at 80%, but it’s still very high. As the report writer comments, “emailing documents puts information outside of controlled processes, making it harder to track and collaborate efficiently.”
Benefiting from the synergies of cloud and mobility
These concerns are relatively easy to address when we work with CROs and help them transition to a cloud-based clinical trial management system. In the cloud, they can easily and securely share information and documents with their clients and partners in dedicated workspaces. We can configure cloud data storage and systems such as NetSuite, the cloud ERP solution, to be compliant with CROs’ policies and regulatory mandates for auditable, transparent information management.
Mobility and the cloud are complementary and make one another more valuable for companies and their users. CROs can have intense reporting requirements by people who may be at client sites, running projects, at company locations, or elsewhere. When you have mobile access to software capabilities and data in the cloud, you can enter expense reports and project updates anytime, review hours and costs associated with a project, or assess a project’s progress to its next milestones.
Enabling anytime, anywhere business insight and control
For CROs, we often configure the cloud software to enable on-demand reporting as well as broadcast or push reporting by the ERP system. Users can see project updates and financials on their mobile devices. They can also receive prompt alerts whenever an important event has taken place or they need to act. When project managers are well-informed, it becomes easier for them to manage projects in line with KPIs and schedules, and manage costs in such a way that they can maintain healthy margins.
Sales reps and execs can use the mobile and cloud-based application to gain a complete view of all projects and activities with any of the company’s clients. They can thus be fully informed before they start a conversation or respond to a client request. Business managers can also benefit from mobile ERP reporting to assess the profitability of the company’s engagements overall and by individual projects, programs, segments, business units, or lines of business.
We often see that the more successful CROs connect with clients in other geographical regions or countries, which requires them to provision project managers and other contributors there with all needed software capabilities and data. Again, with business systems in the cloud, this is a snap to accomplish. The scenario is similar when a CRO acquires another company.
Sikich for CROs
In the Sikich CRO practice, we keep our engagements open-ended and will support CRO clients as long as they are interested in collaborating with us. As mentioned in our earlier blog post titled “Enabling transformative growth for CROs,” we begin with a thorough business process assessment to document the current state of the business. Then we design the processes and technology to help clients move to where they want to be. We achieve the first major milestones along this roadmap during the initial implementation. Many CRO clients ask us to remain involved to assist them in their change management and become more efficient and nimble with ongoing optimizations.
In each NetSuite deployment, we make use of our library of standardized CRO processes, based on industry-best practices and our insight into CRO trends. Most of our technical work with NetSuite involves configurations that align the solutions with a company’s business requirements. That configurability is one reason why we like using NetSuite for CROs. It makes the system easier to manage and adjust, without the complexities and costs of customizations.
Cloud ERP implementations for CROs usually take several months. Instead of delivering all the functionalities at the same time and overwhelming users, we usually phase them over time depending upon our clients’ priorities. We may start with financials, then add other business activities and project management, and roll out customer relationship management (CRM) functionality in the next stage. We also perform the integrations of laboratory information management systems and other software tools with NetSuite. The end result is a business management platform that is closely tailored to the needs of an individual CRO.