A Technology Foundation for Decentralized Clinical Trials and CRO Operations

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The clinical research organization (CRO) industry is transitioning more and more toward decentralized research studies or hybrid execution of trials. It’s time for CROs to explore the opportunities of decentralized studies for speed, savings, efficiencies, and better patient and sponsor experiences. Sikich consulting teams help CROs adopt the portfolio of clinical studies that fits them best. We deliver a well-proven, powerful cloud software foundation to enable their management of decentralized clinical research trials, finances, other operations, and data.

The evolution of clinical trials

CROs performing clinical trials to determine the safety and effectiveness of new medications, medical devices, or treatments have always sought to run their research studies as efficiently and quickly as possible. The sooner research sponsors receive results, the better they can make the right business decisions and plan their next steps.

Before the global pandemic, CROs had begun exploring decentralized trials, where at least part of the data collection and patient engagements are managed remotely through technology. Decentralized research studies could provider better access to larger and more diverse populations of patients who didn’t reside near the clinics and other sites used in centralized, on-location trials. They also could help streamline the management of research studies and accelerate data gathering and analysis.

In the first months of the pandemic, many CROs paused clinical trials. Too many patients were unable to travel to data collection and interview sites. Requirements for physical distancing complicated operations, and pandemic-related staff shortages resulted in further disruptions. The industry quickly recovered and continued delivering research as more CROs more broadly adopted decentralized trials. These forward-looking CROs include many organizations the Sikich life sciences team meets as prospects and clients. As the majority of patients and care providers appear to be satisfied with the quality of telemedicine and digitally facilitated appointments, it’s likely that decentralized trials will be part of the operating standard for CROs.

Software decisions on the way to decentralized and hybrid clinical trials

Today, fully 100 percent of CROs surveyed during a McKinsey Clinical Operations Roundtable expect that decentralized, virtually managed trials will be a major component of their project portfolios. Many CROs have adopted a hybrid model for their research studies. The trend we see is that few trials will be completely decentralized or centralized. Instead, most of them will incorporate some decentralized elements, powered by digital technologies whenever they make operational sense and help achieve the speed and efficiency CROs look to achieve. Bolstered by in-home patient visits by nurses and a greater variety of possible locations when study participants need to be seen in person, such as pharmacies or pop-up clinics, CROs manage many phases of their research studies virtually.

CROs are investing in the technologies that help them decentralize larger portions of their research studies and deliver data to sponsors. They are also modernizing and integrating their systems to simplify the management of decentralized trials and their data flows. In doing so, they have to make the best possible technology decisions to transfer data from patients to their storage and reporting systems. They also need to make it easy for staff and patients to gather and submit data in a secure manner.

Many CROs experience some uncertainty regarding the potential costs and the likely ROI of technologies they introduce. Some also find it challenging to work with sponsors, researchers, and study participants spread across the country or even more broadly.

A short onramp to modern CRO management software

Decentralized trials is one area where CROs’ goals, capabilities, and opportunities can easily outpace their technologies. When they introduce decentralized elements into study trials or modify processes in other ways to address changing business needs, they often increase staffing instead of modernizing or replacing technology tools. That can lead to complexities and overhead at cross currents with the speed, cost control, and resource efficiencies they seek. As CROs grow, they may not find the time to update the technology tools they used in earlier days. As a result, they may use spreadsheets and email to record and share data related to decentralized research studies. Often, CROs still use QuickBooks as the financial system when a CRO has long outgrown it and therefore need a more comprehensive ERP solution. The CRO technology environment typically also includes industry-specific tools, like laboratory information management system (LIMS) software.

Sikich has worked with many CROs and life sciences organizations to modernize and streamline their technology to support their business journey. Building on NetSuite, we have created an ERP platform that is optimized for the CRO industry, Sikich SuiteSuccess for CROs. SuiteSuccess for CROs can replace the traditional spreadsheets and email exchanges with a single, easy-to-learn resource for entering and retrieving financial and other business data. The solution is cloud-based, so users anywhere can access it to enter information about research studies, such as percentage to completion, milestones, expenses, times, and more.

SuiteSuccess for CROs includes a set of flexible templates for common types of research studies. By using these templates with minor adjustments, Sikich CRO clients have managed to reduce the time needed to initiate a new project by over 80 percent.

Connected software environment for diverse research study models

As a cloud technology with relatively low startup cost, predictable OpEx spending for ongoing operations, and a short implementation time, SuiteSuccess for CROs helps CROs offset the costs of purchasing new devices and software tools to generate and collect data during decentralized clinical trials. Automation of such activities as contract management, invoice approvals, and billing can reduce administrative workloads and contribute to controlling costs.

Often, SuiteSuccess for CROs will assume the functionality of stand-alone, specialized LIMS, general ledger, project management, or other software tool once we migrate data into the ERP system. If, because of client preferences or the capabilities of specialized software tools, it’s preferable to keep these systems running, our CRO consultants integrate SuiteSuccess for CROs with them and still enable a unified technology environment. All the way from business development through billing and project reporting, CROs can run their research trials on one software foundation, without rekeying data.

For some CROs, deploying SuiteSuccess for CROs in integration with Salesforce is the best way to move forward. They rely on Salesforce to manage sponsor and vendor relationships and improve the sponsor experience with a seamless configure, price, quote (CFQ) process that bridges sales, finance, and client relationship management.

Role-based information access and advanced security

With SuiteSuccess for CROs, data becomes readily accessible for users across the business and is always available for the financial and operational reporting and analytics built into the solution. In addition to making business data available through the cloud, CROs or Sikich consultants can also provision purpose-designed SuiteSuccess portals to give executives, project managers, sponsors, and others access to information that matters to them.

As decentralized trials generate large amounts of data from the potentially risk-exposed edge, CROs can rely on the security capabilities that are part of SuiteSuccess for CROs. The NetSuite technology benefits from Oracle’s global, redundant infrastructure with a 99.7 percent uptime commitment and layered data protection measures. When we configure SuiteSuccess for CROs, we augment the security of the ERP system with CRO-specific compliance management.

The cost model for decentralized trials is unlike that of traditional, centralized research studies, and CROs need to use different data sets to estimate their costs and recognize revenue. They may also face scrutiny from auditors and regulators. The Sikich team knows how to ensure compliance no matter whether your CRO runs a mix of decentralized and decentralized trials or leans toward either type.

Here to help

Sikich is committed to the success of the life-changing, hugely beneficial work of CROs. When we collaborate with you, we consider your entire business journey and strategy, not just the current state of the company. We incorporate future-resilience in our recommendations and technology deployments, so that SuiteSuccess for CROs and system integrations can support growth and change in your organization.

If you’re interested in exploring what SuiteSuccess for CROs and Sikich expertise could help you achieve:

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

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