Easing the management of clinical trials and vendor studies

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Collaborations between life sciences companies and contract research organizations (CRO) can be as complex and delicate as they are business-critical for the companies involved. As they make financial and operational decisions, they may give rise to consequences that impact their organizations for many years. Expertise and industry-optimized technology can help structure productive life science company and CRO engagements and make stakeholders’ lives easier. During our “Discovery to Delivery: Maneuvering the Milestones” event for life sciences, three industry experts discussed challenges and technology solutions in the areas of clinical trials and CRO-led vendor studies.

Critical, yet different roles for finance managers in large and small life sciences companies

As finance expert Marc Van Hulle of Atea Pharmaceuticals describes, smaller and large life sciences companies experience different challenges in managing their business activities. Big pharmaceutical and life sciences firms may own many different systems to manage contracts, vendors, clinical trials, and back-office processes. Driving a new initiative requires negotiations with many individual stakeholders and business groups. On the other hand, a finance manager in such an organization may be able to access and leverage multiple budgets, for example, to reprioritize the expenses of clinical trials while remaining within budget parameters.

Industry insiders in conversation

Marc Van Hulle, Senior Director, Financial Planning and Analysis, and R&D Finance at Atea Pharmaceuticals, has spent close to 10 years in life sciences startups and just as long in large pharmaceutical companies.

On the Sikich team, Chris Manchester, Solutions Architect, and William Tamulynas, Managing Consultant, NetSuite, each have assisted life sciences companies for over 10 years manage their operations with the best of what technology has to offer.

Being out of touch and not having direct interactions with CROs can be a disadvantage for business managers in a large life sciences organization. They may also lack visibility into the details of research studies until they are reflected in a work breakdown structure.

In contrast, finance managers in smaller life sciences and biotech firms may play a larger, potentially more risky role in negotiating contracts with CROs and structuring clinical trials. They may also need to be concerned with appropriate data capture and experience the pressure of make-or-break clinical trials in a small life sciences company. Van Hulle recommends that finance managers become involved in CRO negotiations as early as possible, so they can ensure timely and accurate reporting from the beginning of the engagement. When CROs need to understand the importance of a clinical trial for their client’s success and financial standing, it is often a finance manager who is in the best position to communicate critical requirements for reporting and the overall collaboration.

Modernizing technology to enable fast, agile business

For finance managers in both large and small life sciences companies, time, flexibility, and speed are essential factors. Competitive intelligence or other conditions can change anytime, and won’t stand still after a company and a CRO sign a contract. Processes and systems need to be able to accommodate rapid change while maintaining the transparency and compliance of financial data and workflows. Van Hulle volunteers that the kind of vendor study functionality Sikich offers in SuiteSuccess for Life Sciences, its industry-optimized version of NetSuite, can greatly help address these challenges and minimize compliance risks.

For many biotech companies and CROs, business has grown so quickly that technology investments have not kept apace. Working with CROs as well as the life sciences organizations that retain them, Sikich consultants often help these companies modernize their technologies to enable greater agility and visibility. Many of them still rely on spreadsheets and manual processes to share information after the events, not in real time. CROs frequently manage approvals for prices and quotes manually and may lack automated systems to manage billing methods and milestones. Those circumstances may delay study trials and can present additional hurdles when organizations need to manage trials remotely and enable widely dispersed teams to be effective.

For many CROs, revenue recognition, the quote-to-cash process, and flexible billing are high priorities when they decide to replace legacy technology. CRO executives also tend to be concerned about the resourcing, pricing, billing terms, and profitability of projects. Today’s cloud software tools can address these concerns if they are properly deployed and configured.

Resolving today’s concerns with a long-term perspective

A pharmaceutical executive recommends in our article “Roadmapping the journey to going public for life sciences companies” that life sciences companies choose and implement ERP and other systems and data structures in such a way that they can be of benefit at the current moment as well as years into the future. Van Hulle agrees with that approach, and the Sikich team often helps companies take advantage of technological capabilities and opportunities that have significant consequences for a long time. On that journey, the consultants address common questions in client-specific ways.

For instance, many organizations need to decide whether ERP should be the main software tool for all business processes and to what extent they should continue using specialized systems for certain tasks. They may also see opportunities for automations in vendor management, procurement, and accounts payable that become possible with ERP. The right timing, integrations, and workflows for delivering these capabilities while ensuring regulatory compliance is different for each organization. ERP and other technologies can also enhance a company’s working culture. Van Hulle points out the potential value of an ERP system at any time in the life of a company in supporting productive internal conversations as business managers and teams think about the results of their work.

Enabling effective collaborations and secure data flows

The right technology, bolstered by expertise in the business models that come into play, can contribute to making interactions between CROs and life sciences companies more productive during clinical trials. It can simplify and safeguard any kind of information exchange, not just of financial data, and help CROs and their clients collaborate in a better alignment. Sikich uses a large portfolio of solutions from several leading vendors—including ERP, CRM, project management, and professional services automation (PSA) systems—to enable these businesses to manage their financials, sales, projects, partnerships, and workforces.

Sikich life sciences and CRO expert consultants are expert at delivering low-risk, efficient technology deployments that can resolve our clients’ most pressing challenges. Through robust, business-driven integrations, we also help companies continue to gain the value of their specialized or proprietary systems and the data that resides in them.

Here to help

Sikich is proud of many long-standing technology relationships with life sciences and CRO clients, including clinical trials. In addition to software solutions from today’s leading innovators, we deliver a broad portfolio of services, from everyday support and technology management, to cybersecurity and strategic consulting.

To explore how engaging with Sikich could help your life sciences organization, you can:

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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