As the global population grows and ages, the demand for science and technology to tackle humankind’s critical challenges intensifies. Life sciences companies face growing pressure to deliver innovative solutions—quickly, safely, and sustainably—while navigating increasingly complex regulations. In response, legal departments have shifted from a traditional risk management role to a strategic partner responsible for driving business value. More and more, life sciences legal teams find themselves in reactive mode, focused on keeping up with growing demands and, as a result, often lack the time or resources to ensure they’re operating at peak efficiency and effectiveness.
Highly regulated companies across the life sciences spectrum, including Consumer Health and Over the Counter (OTC) Products, Biotechnology, Pharmaceuticals, and Medical Devices, must operate within some of the most complex legal frameworks. Multidistrict product liability, IP litigation, antitrust and government investigations all burden legal teams and create high-volume routine litigation along with a select set of bet-the-company matters that may impact the bottom line. Additionally, life sciences companies have global, high-worth patent portfolios and volumes of contracts that span healthcare providers, clinical trials, and R&D partners that require time and resources to manage effectively for optimized business growth.
Benefits of a maturity assessment
In the face of these complexities, organizations are seeking opportunities to boost efficiency, especially when brand or product groups operate in silos. Conducting an analysis of a legal department’s current state and areas for improvement, i.e., through a maturity assessment, produces a baseline from which to prioritize activities and measure success. This analysis can be conducted across an entire organization or separate business units and results in surfacing gaps and uncovering areas to streamline, standardize, and scale operations.
High-value areas to examine
Based on our extensive experience collaborating with legal teams across some of the world’s largest consumer healthcare companies, we’ve identified four key areas that consistently help even the most advanced legal departments unlock greater efficiency, reduce risk, and deliver more strategic value to the business.
Standardization
Inconsistencies in legal processes are a common—and costly—source of inefficiency. While full standardization may not be feasible due to global organizational structures and varying regional regulations, companies can and should align processes where possible. Areas such as contract templates, trademark monitoring, and patent prosecution are prime for harmonization.
A maturity assessment will uncover quick wins by identifying where consistency can drive efficiency across regions or business units. For instance, in a consumer health company, procurement processes for ingredients are often handled independently as teams work autonomously. Similarly, layers within contracting processes—spanning multiple markets and jurisdictions—are conducted differently. These types of legal operations should be reviewed collectively to assess what’s working, what’s not, and how best practices can be scaled across the organization.
“When there are various brands housed under a single company, they routinely operate independently. But with separate teams, comes nuanced processes and consequently excessive duplication.”
-Jay Essley, VP, Corporate & Commercial Legal
Disaggregation
Aggregation of tasks and responsibilities is another common pitfall where inefficiencies build over time. In the demanding Life Sciences industry, the pressures of looming deadlines create scenarios where a 20-year, highly specialized regulatory attorney ends up reviewing basic procurement contracts, becoming an expensive waste of their expertise. Having a strong resourcing strategy enables work to flow to the right teams both internally and externally, ensuring that high-complexity tasks are performed by individuals who deliver high business value. While it may feel counterintuitive to slow down and implement this framework, organizations can achieve big gains by matching senior talent with strategic tasks and directing routine tasks more efficiently and inexpensively.
“Having senior talent review and categorize documents is a waste of precious resources. Solidify your swim lanes to ensure all resources are focusing on tasks where they can provide the most impact and value based on their skill set, experience, geography, and cost.”
-Ryan Reeves, EVP, Litigation and Investigation Solutions
Tech-accelerated insights and data reduction in litigation (especially multidistrict litigation)
Defending large litigation requires gathering massive amounts of data that must be handled efficiently to optimize the efforts of attorneys seeking evidence in the matter. From a vast initial dataset, determining what key facts are most important to the litigation strategy can take months. Relevant documents must be produced, redacted and/or labeled for confidentiality, or withheld for privilege and logged during discovery. This can sometimes take years to review rolling data sets that become subject to discovery. However, by proactively identifying and limiting false positives in the early stages and accelerating key facts and evidence, legal teams can dramatically reduce both the volume of data, and the resources required to manage it—unlocking three major opportunities for efficiency.
First, using analytics and portable AI-models designed for life sciences matters can surface key documents within weeks. This early data assessment enables legal teams to make initial decisions about case strategy. Second, data reduction combats long-term data hosting costs. Applying the right technologies and processes to take data reduction efforts to the next level, you can reduce the existing dataset by as much as 95%. Third, by eliminating irrelevant content early, legal teams can drastically reduce the number of documents AI models can categorize in preparation for attorney review and quality control, saving substantial costs, even for the most streamlined teams.
“It’s tempting during a high stakes and complex litigation or investigation to leave no stone unturned, but paying to store and review irrelevant data or not take advantage of proven AI models for data reduction and initial categorization is an enormous waste of time and money.”
– Ryan Reeves, EVP, Litigation and Investigation Solutions
The tech stack
After growth, change, or mergers and acquisitions, it’s common that life sciences organizations accumulate various, and even duplicative technologies. For this reason, including the tech stack in a maturity assessment can identify utilization rates, redundancies, and opportunities for combined purchase power. It can also determine whether and how tech works together to create more cohesive functionality and reporting. Partnering with a service provider who has expertise in a broader spectrum of trusted technology can help legal departments better leverage the benefits of those resources without adding to their existing stack (and likely reducing and centralizing).
“When divisions within a company operate in silos, they often end up with duplicate software and technology licenses that, when combined, increase their buying power for better deals or fewer organizational licenses.”
-Jay Essley, VP, Corporate & Commercial Legal
Is it time for a maturity assessment?
The intense focus on day-to-day demands, combined with the inherent complexity of the life sciences industry, can cause companies to stop short of fully streamlining these and other processes. If it’s been a while since your last operational analysis—or if you’ve never done one—it may be time to assess workflows and identify opportunities for improvement. A maturity assessment can help establish a baseline and uncover “high return, low risk items” that result in efficiency gains. Visit this page to set up a short introductory call with an expert to discuss an initial maturity assessment for your company.
