Pharmaceutical companies create, market, and dispense drugs authorized for use as medication. Several parts of this process deal with contracts, such as R&D, quality, and product supply agreements, which can be affected by the challenges that come with globalization.
Pharma depends on the regulations and guidelines issued by local governments for healthcare industry processes, including testing, patenting, and advertising meds. For example, US companies rely on FDA conclusions, but if you want to sell in Europe, you need to check with the EMA and the laws on advertising drugs in each particular country.
It may be difficult to keep track of contracts considering such challenges. That’s where contract lifecycle management—pharma CLM—systems come in because they offer functionality for creating, storing, and handling your pharmaceutical contracts. This article will take a closer look at how this functionality can benefit your business.
Developing and selling medication involves a lot of entities, but how often do they communicate about contracts? There may be a disparate view of contract deadlines and renewal dates between the R&D, manufacturing, and legal departments.
CLM software provides one true source of data that includes any dates stated in your contracts. This means all departments can have access to current information. A good CLM will also have a feature for setting reminders about deadlines and renewals.
You must comply with homeland organizations, such as FDA and its Current Good Manufacturing Practice (CGMP) regulations. But there’s also an added layer of compliance with local regulations if you decide to open a lab in another country. Then, you’ll need to ensure the contracts related to this new lab comply with local laws concerning R&D, manufacturing, and conducting business in general.
In this case, automated contracting solutions like AXDRAFT can help you create compliant documents by unifying contract language, ensuring documents are created from the latest template versions, and that everything is approved by the legal team. You can develop a template that incorporates all aspects that ensure you are, for example, FDA-compliant, and contracts made with it will follow one standard form.
Hardly any company would store contracts in a filing cabinet these days. Using a cloud system like Google Drive or OneDrive is more convenient, but you may encounter issues since such solutions don’t offer much contracting functionality–or sufficient security.
A CLM system is more suited to storing contracts because:
- It provides functionality for creating a library of standard templates you can use to form new documents automatically.
- It’s easier and quicker to find information in contracts, such as key deliverables and dates of expiration or renewal.
Another issue with online storage not dedicated to contract management is that you may run into issues, such as broken links. Or imagine this situation: you’re looking for a particular document on the drive, but someone changed its name or location.
Instead, using a pharma CLM allows your team to access contracts and associated documents anytime from anywhere easily. In AXDRAFT, for example, you can also manage who has permission to view or edit documents more efficiently because it’s done at the user level—there’s no need to check each contract.
The contract lifecycle in a complex industry like pharma can be difficult to oversee and manage. Any complex process introduces a high risk of human error as well.
Instead, a CLM system can help automate and streamline certain aspects of the contracting process because each stage is viewed as a task. Such tasks can be requesting contracts, creating documents from templates, signing them electronically, and getting alerts when the contracts must be renewed.
Getting medication to the market involves a complex chain of relations, especially if you deal with prescription meds. Depending on how many firms you outsource to, you also need to ensure each stakeholder is compliant.
CLM helps pharma companies have better visibility into contracts with suppliers, maintain regulatory compliance, and reduce contracting risks. This is because contracts are created based on pre-approved templates, and after an agreement is ready, the system will send it to the legal team for review.
Contract lifecycle management software helps legal, procurement, and contract administration teams automate certain processes in contract creation, negotiation, and execution. Also, it provides an easily accessible and searchable library of templates and contracts.
A pharma CLM like AXDRAFT helps ensure compliance, provides centralized storage, and improves visibility. Take a tour of the system to learn more.