As biotech, pharmaceutical and other life sciences companies grow, new operational, regulatory and security demands emerge that often go beyond internal capabilities. While organizations rightfully focus on the science and development at first, back-office challenges can disrupt growth plans or create vulnerabilities.
Outsourcing continues to be a critical solution to help life sciences companies of all types manage these issues, gain additional support and streamline business processes. While outsourcing can strengthen operations across the business, we are seeing strategies making a significant difference in four key areas:
A variety of biopharma companies typically need to scale resources rapidly as their companies evolve. From R&D to clinical trials to public market readiness to commercialization each new phase creates new or increasing resource demands that typically overwhelm the internal support and operations teams. As is often seen during the early stages of a newly formed biopharma company, companies often operate in a streamlined manner and may leverage outsourcing services with the desire to keep the focus on the science. Additionally, as the US Federal Government’s (USG) continues to increase its investment in the life science industry through federally funded grants and contracts – the ability to scale up quickly to meet the size, scope, and reporting requirements of USG awards becomes a differentiator for many life science companies.
For example, as a company moves from a pure research organization to clinical trials it will become necessary to establish a more comprehensive outsourced technology infrastructure partnership to support growth and the changing business needs. As companies bring on new employees, and multiply in size, outsourcing can help effectively streamline the new user onboarding process, scale technology platforms and provide more resources, both from a manpower and knowledge perspective.
Meeting enhanced accounting and regulatory demands
Outsourcing can also provide a depth of accounting acumen and resources to help manage new challenges that come with growth and revenue recognition. Companies often have some in-house financial resources, but finance and accounting outsourcing (FAO) solutions bring a higher level of sophistication to manage specialized accounting demands and manage increased transaction volumes and financial reporting.
Furthermore, new revenue recognition, lease accounting standards and increased cost accounting and reporting requirements associated with federally awards puts added pressure on internal accounting personnel. FAO solutions allow organizations to tap into more technical resources and experience to manage these complex accounting demands. Maintaining this level of resource in-house is expensive; FAO enables companies to utilize solutions on demand, when they need it, as a variable cost instead of a fixed cost.
From a compliance perspective, an outsourcing provider can assess and provide adherence with regulatory demands such as FDA 21 CFR Part 11 guidelines for electronic records and signatures, Sunshine Act reporting and FDA validation. With the many complexities and increasing regulatory compliance requirements associated with commercializing, companies can sometimes overlook the growing amount of additional processes and compliance standards that are necessary. Outsourcing solutions can help confirm that processes align to these standards, and point companies in the right direction to eliminate gaps and ensure ongoing compliance.
Strengthening security and privacy
Life sciences companies, particularly those in the biopharma sector, work with extremely sensitive data and intellectual property (IP), and outsourcing can help protect their IP. Companies are particularly vulnerable when employees who may have been involved with R&D leave the organization. These individuals must be prevented from retaining or regaining access to sensitive company information and systems.
Accordingly, an outsourcing provider can implement a technology platform that includes proper access controls, data leak prevention and enhanced auditing capabilities. These solutions can help control, limit or deny unauthorized user access, as well as provide end-to-end visibility into the location, flow and usage of all sensitive data across the enterprise.
Enhancing human resources capacity
As biopharma organizations grow, their needs often surpass internal human resources capabilities. Roles and responsibilities can change rapidly causing a need for clear alignment of skill sets with the changing needs of the organization. Therefore, many companies are outsourcing HR processes to manage new challenges. These challenges can seemingly arise overnight and include compliance issues when companies scale up a sales force in multiple states with complex sales compensation schemes, and more extensive benefit plan design and administration demands.
In addition, outsourced HR can provide more insight when making difficult decisions about the acquisition and retention of talent. For example, it may make sense for some life sciences companies to outsource the entire sales or manufacturing function, while others may want to keep those processes in-house. Outsourced HR solutions can help organizations understand the total cost of the employment scenario for insourcing versus outsourcing these functions and implement the infrastructure to manage and retain their talent.
Ultimately, an HR assessment can help biopharma companies ensure they have nimble HR resources that can scale with demand. An organization must be proactive to be successful, keeping HR people, processes and technologies growing along with the business. A comprehensive HR assessment can help determine what outsourced functions will work best for a specific company, from payroll and benefits to Family Medical Leave Act and recruiting.
With the rapid growth necessary during the life cycle for life sciences companies of all types, internal resources often cannot keep up with the velocity of new demands. As your needs change and evolve to fit the demands of the market, both the scale and urgency around accuracy and proficiency becomes front and center. Outsourcing is a common strategy in the life sciences industry, and understanding and appropriately leveraging which solutions align with your business structure and goals can help establish a strong foundation for current and sustained success.