CLM for Biotech: Using CLM as an Extension of Your Lean Team

On top of gathering study participants, setting clinical trials, researching new drugs, and much more, biotech companies need to ensure they’re following strict compliance regulations. Contracts are at the center of this crucial requirement. 

Contracts guide your relationships with vendors, participants, and partners. Without them, your clinical trials stay grounded, your budget is a mess, and your compliance audit trail is wonky. Some companies do as many as 120 contracts a quarter! With that kind of volume, how are you keeping track of all your contracts, ensuring they go out on time, have the right language, and comply with ever-changing regulations? 

If your answer is that you aren’t, and if your trials are getting pushed back because your contracts are all over the place, consider contract lifecycle management (CLM). CLM for biotech is an extension of your legal team, handling pre-signature complexity and post-signature contract storage and reporting, streamlining your contracting process overall so you can get back to what you do best: innovate. 

Tasks You Can Hand Off with CLM for Biotech

Here are some ways that CLM can take extra work off your plate:

Streamline pre-signature agreements

From CDAs to provider agreements and IP clauses, your contracts govern your outsourced materials, help get your trials done on time, and protect your intellectual property.

Your contract creation process may be haphazard,  created from random templates found in old G-Drives or desktop folders. Even worse, non-legal employees might be generating these agreements. You can’t track what’s being created, which means when it’s time for review and approval, you end up doing double the work. A non-existent contract process slows you down and puts all your hard work at risk.

Implementing CLM for biotech helps you keep track of contract creation and execution. Automate your review process and make your contracts self-service. Using workflows and pre-approved templates, there’s no reason your contracts can’t get out the door on time.

Maintain Regulation Compliance

Trying to develop a new drug? Need to work with a vendor in a different country? Want access to recruit for your clinical trials? There’s a regulation for that. 

Biotech is no stranger to heavy regulations, especially as your business expands and you need to work with more vendors. Failure to follow these rules opens you up to risks and heavy fines, which eat into your profits. 

CLM for biotech helps you organize contracts by location and regulation, providing a quick bird's eye view of live agreements. Maintaining audit trails to prove compliance has never been easier. 

Stay on Budget

Contracts that take too long can cost you money in many ways. First, you’re delaying revenue recognition. Second, you might find that you’re late on payments or unaware of financial obligations because there’s no way to know what your obligations are. 

When you find yourself off-budget, late with clinical trial payments, and paying for more things because you don’t have anyone to keep track of what has already been purchased, you know you have a contract management problem.

Contract Lifecycle Management for biotech can help you keep track of obligations and financial reporting to stay on top of pricing schedules and control your spending. 

Move Fast and Protect Your IP Better

After you’ve spent years on R&D, the last thing you want is for someone to run off with your ideas and make money off your hard work.

But when you have an ad hoc contract management process, you can never be one hundred percent certain that your CDA or IP agreement — or even just your basic terms of service — have the exact right clauses. That uncertainty can cost you millions.

CLM for biotech can help you automate your agreements and templatize your IP clause language. You can even keep an eye on third-party agreements that have questionable clauses and address them quickly and efficiently.

In Summary

Biotech companies have a lot on their plates. The legal team, or person in charge of contracts, is often being pulled in multiple directions at once, and that leaves the door open for human error and her best friend, risk. For companies that find themselves behind on contracts, a lifecycle management solution for contracts can make a world of a difference in the way you do business. Instead of having senior members draft contracts, hand off some of that work to a CLM so that they can handle strategy. 

Learn how LinkSquares CLM can help get your biotech company on track with contracts. Schedule a demo.