How CLM helps ensure compliance in the biotech and pharma industries 

When Elizabeth Holmes founded Theranos in 2003, she proclaimed to have a vision: to revolutionize the world of phlebotomy by inventing a device that could perform a wide range of diagnostic blood tests – from diabetes to cancer – all with only a few drops of blood.  

The problem? 

None of it was true. 

Holmes’ technology was later revealed to be fraudulent, with Theranos going as far as outsourcing bloodwork to traditional labs and claiming to have run it through their machines. Ultimately, Holmes was convicted to 11 years and three months in prison and Theranos’ machines were removed from Walgreens locations across the country. 

Luckily for the American people, regulatory agencies like the Food and Drug Administration (FDA) as well as the Centers for Medicare and Medicaid Services (CSM) caught Holmes’ deceit, and they helped prevent Theranos from further endangering the public’s health and wellbeing.  

These regulatory agencies are designed to protect us, and they often do just that. However, the associated regulations can also pose quite the headache to those involved in the contracting processes within these industries. Legal professionals in these spaces have heightened concerns about compliance – and rightfully so. 

A brief glimpse of the regulatory landscape

The pharmaceutical and biotechnology industries are heavily regulated to ensure the safety and efficacy of the products being sold in the marketplace. Regulatory agencies such as the FDA in the United States and the European Medicines Agency (EMA) in Europe have established guidelines and regulations that govern the development, manufacturing, and marketing of drugs and biologics. 

Some of the common pharmaceutical regulations include:  

• Current Good Manufacturing Practice (CGMP): CGMP regulations require drug manufacturers to follow minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations ensure that a product is safe for use, and that it has the ingredients and strength it claims to have.
• Anti-bribery laws: Biotech and pharma companies must comply with anti-bribery laws such as the Foreign Corrupt Practices Act (FCPA) in the United States and the UK Bribery Act in the United Kingdom.
• Data privacy laws: These companies must comply with data privacy laws such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States.
• Environmental regulations: Biotech and pharmaceutical companies must comply with environmental regulations such as the Resource Conservation and Recovery Act (RCRA) in the United States and the Waste Electrical and Electronic Equipment (WEEE) Directive in Europe. 

How to use technology to streamline compliance

In the face of rapidly evolving regulatory and marketplace demands, compliance teams are under constant pressure to do more with less, often requiring the use of new technologies, Deloitte notes. Once these new technologies are available, they can help not only drive efficiency and efficacy, but also help improve an organization’s ability to adhere to compliance, protect its business, and deliver value. 

Such transformative technologies include robotic process automation, natural language processing and generation, predictive analytics, and Contract Lifecycle Management (CLM).  

Benefits of CLM for biotech and pharma companies

CLM offers a wide variety of benefits to a multitude of industries ranging from healthcare to manufacturing to nonprofits. But for those working in the areas of biotechnology and pharmaceuticals, CLM can be a game changer when considering the amount of manual work required in such tightly regulated industries, said Koho Consulting’s Pepe Toriello in a webinar on the topic.

“We’ve seen that there’s been a lot of interest from especially biopharma and biotech companies to get everything automated, or as much as possible, because there’s a lot of really manual work because it’s a very highly regulated industry,” Toriello explained. “There’s a lot of compliance work, [so] there’s a lot, of course, contracting work.”

And the biggest pain point, other than compliance? A lack of visibility of their contracts.

“If you do not have the complete visibility of your contracts and how you can manage your vendors or your customers, there’s a high probability that your legal risk and financials will be higher,” he said.

6 major benefits of utilizing a CLM system in biotech and pharma:

• Streamlined contract management & process control: Streamline the process of governing, organization, and automating contracts across the enterprise with seamless Word, Outlook, Salesforce, and other integrations.
• Accelerated negotiations and turnaround times: The last thing you want is a contract cycle that’s eating up too much time. Get to market faster than competitors with expedited internal and regulatory approval flows. 
• Improved compliance: Our no-code platform not only makes going digital easy, but it also keeps you compliant. Implement and manage access controls, eApprovals, user- and role-based security, and audit trails with timestamps to keep you on track with various regulatory agencies.
• Discover potential risks and non-compliance: Current methods of handling contracts can leave you exposed to potential risks. Our platform helps you identify gaps in your active contracts while enforcing best practices through policies and workflows. 
• Improve your bottom line: End service disruptions and unnecessary spending with proper renewals management so you never miss end-of-term renewals or timely cancellations. Meet all your obligations and stop paying penalties for missed disclosures and payments. 
• Make better decisions: Gain insights into your financial and compliance performance. Make better decisions with transparency into your revenue flows. 

To learn more about how CLM can help you succeed in biotech and pharma, watch our on-demand webinar here.