LIFE SCIENCES COMPANIES TYPICALLY ARE GROUND-BREAKING, RISK-EMBRACING BUSINESSES THAT HAVE THE POTENTIAL TO CHANGE MANY PEOPLE’S LIVES FOR THE BETTER
At Sikich, we’re enthusiastic about supporting life sciences businesses as they grow. We are proud of the life sciences clients who trust us in implementing their business management technology and contribute to their long-term technology strategy.
Most standard ERP and CRM software products would take significant customization to fit the unique operation model and working conditions of a life sciences company. However, Oracle NetSuite has the power and flexibility to become a platform on which life sciences organizations can manage their programs and processes, along with their contributors and resources.
Largely through the strength of client referrals and a highly committed team, during the last few years we have been privileged to deploy NetSuite in several dozen life sciences companies. While every organization is unique, some of their challenges and the best ways to address them are very much the same. The Sikich Life Sciences Practice builds on our successful projects to deliver a version of NetSuite that comes with commonly needed workflows, reporting, functional roles, and compliance enablement features. Because timeliness and speed are often essential in this industry, we can implement the solution rapidly.
NetSuite is one of the world’s most widely adopted and well-proven cloud solutions, used in more than 40,000 organizations in over 100 countries. In 2018, Sikich won a 5-Star Award from Oracle NetSuite at the company’s SuiteWorld18 conference. This honor is awarded to top-performing technology providers who demonstrate outstanding expertise, creativity, and client-service quality in implementing NetSuite.
ENSURING THE LONG-TERM VIABILITY OF LIFE SCIENCES BUSINESSES
Life sciences companies often start small, and their business operations may remain so even as the organization and its activities expand. While scientists and researchers explore promising approaches to new medication or other vital pursuits, a core group of finance, IT, and business managers is responsible for business processes and infrastructures. Some life sciences companies go public with just a handful of people on the finance team. Even with demanding system workloads and stringent regulatory requirements for managing data and intellectual property, the IT team often remains small as companies grow and evolve.
WHEN TECHNOLOGY LAGS BEHIND COMPANY GOALS
Many new life sciences businesses begin operating with just the basic essentials when it comes to technology. That often means a fragmented software environment comprising simple accounting software with foundational reporting, business productivity tools that almost everyone uses, and specialty software systems to support and manage clinical trials or support collaborations among far-flung contributors, together with the documents they create and exchange.
Often, a year or two into the life of the business—and sometimes much sooner—it becomes obvious that they are not robust and scalable enough or lack the financial reporting the company needs. Commonly, basic software tools are also not capable of preparing and facilitating equity events.
A PLATFORM FOR SUSTAINED GROWTH
Replacing a business software system can be distracting and expensive, but it doesn’t have to be. Not when you can adjust the entire approach and also shift the venue to the cloud, where technology changes are easy to make and additional computing power or storage can be provisioned at an instant’s notice. If colleagues on your team are still making do with workarounds that rely on paper-based activities or basic software functions with frequent updating and emailing of spreadsheets, you can tell them to breathe easy. Instead, you could implement a cloud business management solution like NetSuite—as versatile and easy to use as most people’s preferred business apps, and as scalable and richly featured as the ERP systems that power large, fast-growing companies.
For many smaller life sciences companies, a critical juncture arrives when they are on a path to going public, but still run the business on the shoulders of a small team. Those business managers need to implement the financial and approval controls and workflows that keep the company compliant with regulatory frameworks such as Sarbanes-Oxley and nonnegotiable requirements like the need to realize a proper segregation of duties.
On the right software platform, you can design, configure, and manage the roles, controls, and workflows the business needs, without necessarily having to onboard more finance professionals or IT managers.
IMPLEMENTING THE RIGHT CONTROLS AND REDUCING AUDIT RISKS
Working with more than 30 life sciences businesses during the last two years, we have made an art of building teamadjusted workflows in NetSuite and helping companies refine them on their own. No matter how big your team is or how complex your project and program operations may be, we can deliver financial approval workflows optimized for life sciences companies with the needed level of transparency and separation of duties. These processes can scale with the scope of your business operations, but their setup and realignments can remain fast and simple.
Auditors scrutinizing your business will want to see that all necessary controls are in place. That includes documentation and tracking of any changes in those controls and associated workflows. In NetSuite, you can easily ensure complete tracking when you adjust any portion of a workflow, and you will not need to make use of an additional change management reporting (CMR) tool. Having CMR within your business management platform keeps the visibility of any process changes high. And, doing so with an instance of NetSuite that’s enhanced for the life sciences business keeps your operational and audit costs under control.
Interpretations of regulatory requirements and how they should be reflected in your workflows and segregated roles can differ among companies in the industry, experienced business managers, and even auditors. We adjust our practice and recommendations to stay current with the most efficient and manageable ways to keep your business compliant and its contributors accountable.
MAKING USERS’ LIVES EASIER
In NetSuite, you can also accommodate your growth, including mergers and acquisitions, or increasingly complex portfolio of departments, programs, or business groups without reimplementing your software. Business users familiar with the operation can make adjustments, add dimensions—and transact and report against those dimensions—and set up and manage multiple business entities or subsidiaries in NetSuite without IT assistance. We can work with you to make sure company structures and processes are efficient and controllable, and help you meet your goals now and in years to come.
ENABLING OUTSTANDING PROGRAM MANAGEMENT AS A COMPETITIVE ADVANTAGE
When life sciences businesses engage with contract research organizations (CRO) to perform pre-clinical testing and other scientific work, millions of dollars can be committed to contracts. Typically, research performed under contract terms comprises multiple projects which are part of larger, longer-running programs. Setting up, operating, and tracking programs and the management of the business relationships with the CROs involved are business-critical, highly consequential activities. Too many times, neither life sciences executives nor program and business managers have the right level of visibility. Given that CRO and program management are areas of the business on which auditors like to focus, limited transparency results in the high risk of unsatisfactory audits and penalties.
INCORPORATING INDUSTRY-BEST PRACTICES
NetSuite provides a centralized repository for contracts, reports, and other important documents. Managing these in a separate tool can be cumbersome and error-prone. But if you do use a document or contract management or lab system that you want to retain, so your users can continue working within their accustomed software environment, we can integrate your preferred software tools with NetSuite.
In optimizing NetSuite for life sciences companies, we also connect financial and program management with stakeholder approvals, using best-practice workflows. If your contract management provides for various levels of required approvals, where managers, executives, the CEO, or even the board have to approve expenditures at certain dollar levels, we can configure the right approval workflows and show you how to adjust them to suit your service vendor engagements. For many life sciences clients, we also have added approval validations and sign-offs to further reduce any risk.
SHORTENING THE DISTANCE TO KEY GOALS
What is likely to change in your business following a fast NetSuite deployment enhanced for the life sciences business?
For one thing, you can take better control of your programs and vendors. You can project accurate financials without surprises, such as overspending. You can set up meaningful budgets and execute to them, and you can implement appropriate approvals for spending and major decisions. Audits can become less painful and more predictable. At an individual level, contributors at any level of the organization receive the information and functionality that allow them to act in the company’s best interests.
Those changes, in turn, can mean a strategic advantage in a highly competitive, rapidly evolving industry where you need to keep your eyes on your goals without being distracted by obstacles and problems that could easily have been addressed.
COMMON SHORTCOMINGS IN PROGRAM MANAGEMENT
Many life sciences companies experience typical program management challenges in one or several of these areas:
- Initial planning was flawed, because it did not consider all available, important information. As a result, program budgeting cannot provide an effective program framework. Overspending is likely and becomes more so through the duration of long-term programs or when the program and project portfolio expand.
- CRO billing is not aligned with the work performed or milestones achieved. Companies lack a reliable system or practice to forecast expected invoicing or tie it to a vendor’s performance. Not only is it difficult to verify whether billing is accurate, you also can’t easily determine what budget remains, nor handle accruals and prepaid balances in a timely and dependable manner.
- Approval mechanisms for high-ticket items like contract amounts or invoicing under CRO contracts may be inconsistent or poorly enforced. The right people don’t always get involved when they should, or approvals are delayed because the process is continuously being reinvented.
- Companies use multiple processes and systems to manage CRO programs, finance, and other business operations. Sometimes, they deploy a contract management system that is separate from financial, reporting, and other software. Or, they use spreadsheets to track programs and their performance. Lacking integrations and process inefficiencies make it much more likely that human error compromises finance management and program decisions, or contributes to underwhelming project and program performance.
These well-known issues are often tolerated when a company’s focus is on achieving certain scientific or medical results, and business leaders may need to handle them as emergencies when they become too troubling. However, it takes relatively little effort and investment to forestall them in the first place.
ENHANCING ERP FOR CONTROL AND TRANSPARENCY
To help life sciences companies avoid and address these shortcomings, we have augmented the comprehensive business management functionality of cloud-based NetSuite ERP with comprehensive program, project, and contract management capabilities, so you can:
- Track your spending to forecasts based on contract terms and benefit from full visibility of the financial and operational aspect of CRO activities at a project and program level.
- See what a CRO vendor’s performance looks like, what the billing implications are, and automatically calculate accruals and remaining budgets with complete accuracy.
- Update your projected spending per month or per quarter based on a full view of your CRO engagements per project or, at a higher level, per program or per vendor. Both project and program managers and their colleagues on the finance team can make accurate assessments of CRO engagements and their financials.
- Avoid overspending and discrepancies, and intervene promptly when vendor performance or business practices demand it.
BOOSTING THE SPENDING VALUE OF PROCUREMENT
In the spending of most life sciences companies, roughly equal amounts go to CRO engagements and the volume purchasing of lab supplies and other goods. Contracts may be few in number and purchasing transactions many more. That lends additional weight to any inefficiencies and poor financial controls in the area of purchasing and procurement.
NEED FOR CONTROL AND SIMPLICITY
When it comes to item purchasing, approvals are essential, especially when the same person might need to set up vendors, make purchasing decisions, and initiate transactions. Many businesses allow this to happen because their staffing is lean or when managers feel that scientists and other subject-matter experts know best what to purchase from what company. With consistent, timely approvals by people who can take responsibility but are not directly involved in the steps of procurement, based on purpose-built workflows configured in NetSuite, we can help you reduce the risk of these activities.
Most life sciences companies want to keep close tabs on their cashflow and spending, especially when they are not yet generating revenue. While their IT is often lean in terms of staffing, in terms of software systems it can be overly complex and cause high management workloads. When life sciences businesses use specialized, separate procurement and contract management tools which may not integrate with their financial software, that complexity can become overwhelming.
MANY WAYS TO STREAMLINE PROCUREMENT
We will always keep your software environment as simple and manageable as possible, and there are several routes to achieve this. NetSuite already includes a full-fledged procurement module, which includes such capabilities as:
- Configurable dashboards
- Automated requisitioning
- Management of Vendors and RFQs
These features can align with your policies and compliance mandates, and they can also sync with the approval workflows you configure or that we implement for you. Your procurement then takes place on the same platform as your other business activities, and stakeholders can clearly see how well it serves the company and supports its goals for financial performance. Automation can keep the amount of administrative busywork at a minimum.
If you prefer another procurement solution, you are not forced to plan on an increased IT workload or put up with disjointed processes. Sikich has created standardized integrations between NetSuite and several popular procurement tools, and we have also implemented them for many of our life sciences clients. One of these is Prendio, a very mature procure-to-pay solution which was developed for biotech and life sciences businesses. The integration created by Sikich connects Prendio to the accounts payable management in NetSuite and to the program and project layer that we implement within NetSuite for life sciences companies. You can directly correlate your procurement to programs and their financial performance.
Coupa is another procurement platform that many, especially larger, life sciences companies use, although it is not specifically designed for the industry. In integrating Coupa with NetSuite, we can ensure that anybody who is authorized to issue POs or purchase goods can easily access the tools to do so efficiently. At the same time, finance managers have the visibility to control spending within budgets and policies.
PunchOut2Go helps life sciences companies keep procurement within acceptable spending thresholds and take advantage of best available rates by surfacing vendor catalogs and accessing them from within their preferred procurement system. We have performed and delivered the required integrations between Punchout2Go and NetSuite for many life sciences clients.
CONNECTING PROCUREMENT, PROCESSES, AND PERFORMANCE MANAGEMENT
There are other procurement systems that are less widely used than Prendio, Coupa, or PunchOut2Go, and for some of these Sikich has created other integrations with NetSuite that can elegantly be repurposed. For users in the procurement and finance departments, we enable visibility, simplicity, efficiency, and speed. Qualification, selection, purchase, and delivery have to happen quickly, or important work may be disrupted. And, you will always be able to correlate procurement actions to vendor records, program budgets, KPIs, and purchase orders managed in NetSuite.
If you’re not used to thinking about integrations as an asset to your life sciences business, it may be time for a change in perspective. You may see integrations differently when you experience how they can organically enhance your business software, adding valuable functionality and extending the reach of your users and digital resources without increasing complexity.
REDUCING THE RISK, COMPLEXITY, AND COST OF COMPLIANCE AND REPORTING
In some companies, compliance and regulatory functions are now defined in separation and different individuals are tasked with them. Compliance may mean remaining fully informed with respect to changing requirements and frameworks, performing process and infrastructural planning, and ensuring that the company budgets appropriately to facilitate its compliance efforts. Regulatory roles translate compliance mandates into everyday processes and actual business roles, interprets them in the light of the compliance discipline, and develop the reporting and controls to maintain and document a company’s compliance measures.
THE EXPANDING SCOPE OF COMPLIANCE
Both regulatory compliance, industry practices, and the standards of individual companies are changing to encompass relationships with customers and trading partners and the management of confidential information, intellectual property, communications, and business processes in the context of these relationships. Compliance managers, for instance, need to ensure that their companies do not have any conflicts of interest with customers or partners and that they follow industry-best practices as well as compliance mandates in managing and storing sensitive data. They may need to implement specialized controls to safeguard patient or proprietary data against cybercrime. When governmental regulation demands measurably better patient outcomes, not just improvements in medications or medical product, they may need to implement additional controls throughout their processes and value chains.
In the life sciences industry, mergers and acquisitions can further complicate the compliance scenarios. Organizations inherit and need to resolve the compliance challenges of companies they acquire; doing so may become more difficult when an acquisition involved an entity in another country with a different business culture.
EASIER AUDITS AND A BETTER WAY TO KEEP UP WITH REPORTING REQUIREMENTS
When we work with life sciences clients, their top compliance-related concern is making audits easier and less risky. To accomplish that and ensure compliance, we design their digital infrastructures in such a way that they can facilitate the reporting and implement the processes that must be in place so they can meet today’s compliance mandates. We also enhance their business foundations with the elasticity and scalability that enable them to keep their compliance practices current with changes in the business and the industry.
Out-of-the-box, NetSuite can provide many of the reports required by the SEC and other regulatory agents. We set the functionality up to be truly turnkey, ready to create and distribute accurate, timely reports. For growing companies, we often expand the reporting portfolio to include multi-country and multi-company operations without adding ambiguities or straining resources. We also help you connect compliance and financial reporting to your organization’s performance metrics by means of KPIs and dashboards that expose the outcomes and trends of your programs and projects for your specific business roles.
Workflows and roles realized in NetSuite by Sikich feature the approval mechanisms and accountability structures that can keep compliance efficient and at the core of the business. That also means role- and process-related documentation is easy to produce and present, including documentation to provide evidence that certain processes have not changed, or that changes made followed proper approvals and conformed to compliance policies.
A FLEXIBLE, ELASTIC SOLUTION—NOT A STRAITJACKET
While life sciences business leaders may have different views of how roles and duties should be segregated, we use our experience from dozens of life sciences projects to help you implement the proper segregation of duties that fits your organization. And, when the company grows and you need to add programs, departments, and other business entities to your NetSuite environment, this can easily be accomplished with reimplementing the solution.
We can perform whatever NetSuite adjustments necessary until you are comfortable reconfiguring workflows, dimensions, and business units on your own. When you need to prepare for FDA testing, which requires specific measures for control and transparency, you can take advantage of many years of practice and thousands of project hours coming together in today’s transferable Sikich expertise.
TRANSLATING DATA ASSETS INTO BUSINESS ADVANTAGES
The medical and scientific innovation and research that is core to life sciences companies is reflected in large and continuously expanding volumes of data. Most often, research and scientific data is generated and managed in applications that are purpose-built for the industry and primarily used by program managers and research and data scientists. A subset of that data also needs to be available to company executives and planners, who typically use their own business productivity and management applications. Some business roles are mostly data consumers who rely on the reports and findings presented to them to make decisions. Others are both consumers and creators of data that are important for a company’s business management and some of which may also be relevant for program and research managers.
DATA MANAGEMENT CHALLENGES EXACERBATED BY SILOS
That complexity of data creation and data consumption scenarios in life sciences companies can almost naturally result in disparate data storage and management technologies and practices. When company cultures foster team identities and encourage employees to focus most strongly on their immediate team’s goals, people and processes may also function in a siloed manner that makes it difficult to move the company forward and make evidence-based decisions.
In addition, life sciences companies may experience very specific data management challenges. Those can include limited scalability of data storage resources, lacking or inconsistent standardization of data formats, conflicting or unclear data ownership, data security, and the high cost and functional limitations of analytical tools. Together, these factors can impede a company’s ability to gain the full benefit of its digital assets in operating and growing the business.
THE RIGHT INSIGHT AND MANAGEMENT TOOLS FOR DATA CONSUMERS AND PRODUCERS
In our collaborations with life sciences companies, we address these issues with NetSuite in the cloud, where storage resources are practically unlimited and cybersecurity is increasingly powerful to stay ahead of digital threats. We will always optimize the solution for the business processes that are characteristic for life sciences companies and fine-tune it to the workflows and operating conditions in individual organizations.
Working with you, we also create two types of user roles. One group includes those who need access to information and reports to make decisions and manage the company. Such dataconsumer roles could be the CEO, the CFO, a key business partner, an investor, or an auditor. They might access a relatively small part of the solution’s capabilities and not use it every day. Another group are people who need to access information and solution capabilities and also produce data. Those might be managers of programs, operations, finance, or compliance, and they are likely to be in the NetSuite environment every day, often using it together with Office 365 or other software tools that integrate with it.
We connect both types of roles to the data sources and business insight tools they need to do their jobs. That often means less worry and greater confidence for users who are used to manual workarounds and informal processes. Data consumers may need access to secondary analytics tools that build on data presentation and reporting already performed by data producers. Their analytical requirements can be complex and the outcomes could be highly consequential for the company.
Data creators need powerful resources to process and manage data and stay on top of the company’s burgeoning data stores. For both groups of users, we design analytics and reporting functionality that suits their roles, including KPIs and dashboards. We also provide them with the most productive ways to receive information and to disseminate data and reports. Those can include email notifications and instantmessage alerts in response to certain program events or financial thresholds. Or, project-based financials and program-level performance management tools. What’s more, all users see data and capabilities in an interface that makes sense and that is easy to navigate, no matter whether they access it from their desktops, laptops, or smartphones, at the office, remotely, or in transit.
CONNECTED BUSINESS FOUNDATION INCREASES TRANSPARENCY AND USER PRODUCTIVITY
As we design the life sciences application environment, we integrate with your existing specialized software tools and data storage resources. You don’t need to replace or abandon the legal software, contract management or document management system, or any other tools that serve the company well. NetSuite comes with a highly versatile integration layer that makes it easy to connect with almost any software tools that are present in a business. In the interest of the often small IT departments in life sciences companies, we keep integrations simple and manageable. Business users can easily make adjustments to their rolespecific capabilities and data access on their own or together with IT.
At the end of a Sikich-managed life sciences deployment of NetSuite, business roles across the organization enjoy better decision capabilities and control. Planning and decision-making are based on timely, relevant data, and are therefore more reliable and advantageous. Compliancerelated and operational transparency of data and processes is at an unprecedented level. Enhanced NetSuite security measures and company-specific data protection we implement, keep users informed and applications secure.