8 Keys to Pharmaceutical & Biotech Contracting Excellence
By David Parks
Effective contract management is critical to any business operating in a regulated industry. Without it, risk goes up, compliance goes down, and your ability to be successful gets severely handicapped. This is especially true with pharmaceutical and biotech companies. Contracts play a major role in virtually every aspect of drug development, commercialization, and innovation for these organizations. In addition, the volume of legal agreements and supporting documents generated by this industry is huge thanks to the complexities of CTAs, CDAs, provider agreements, pricing schedules, and more.
That’s why achieving pharmaceutical and biotech contracting excellence is so important. It enables pharma and biotech organizations to:
- Optimize your legal agreements and contracting processes with data-driven KPIs.
- Increase your contract management agility to accelerate commercialization and innovation.
- Get complete visibility into your entire CLM process to reduce risk & increase compliance.
- Collaborate on contracts with ease and accuracy from any location with customers, partners, vendors and internally.
Let’s look at 8 keys to pharma and biotech contracting excellence that anyone involved in a pharmaceutical contracting process should embrace.
1. Centralize Contracts in a Dynamic Repository
If you manage contracts using shared folders and spreadsheets then it makes it hard to search for the information contained in them. What if you want to search all your agreements for a specific clause, rebate term or drug? Centralizing your agreements in a digital and dynamic contract repository eliminates these issues. It centralizes all of your contract data so that it’s searchable, reportable, and accessible from any device. It’s the first and most important step to achieving pharmaceutical and biotech contracting excellence something made very easy using contract management software.
2. Automate Alerts to Avoid Missed Obligations
Missing contract obligations can have big and small consequences that expose your business to risk. Imagine missing the deadline of a supporting document for a drug application or a certain condition that’s activated by a milestone that makes you eligible for a discount. Setting up automated alerts and tasks is the perfect way to stay on top of these critical contract deadlines. It not only eliminates missed dates and obligations but also the error-prone need to manually track dates using filters and custom sorting in spreadsheets or set reminders in Outlook, Gmail, or iCalendar.
3. Increase Compliance & Efficiency with Digital Clause & Template Libraries
Drafting an agreement can be time-consuming when staff members are unsure if they are using the right legal language. This is especially true when it comes to pharmaceutical contracts. A study done by IFPMA found that the average CDA, for example, is over 4,000 pages long. This uncertainty is a liability and hard to avoid when using manual contract management techniques. Creating shared and legal-approved clause and template libraries is key to increasing the productivity and compliance of any contract process.
4. Collaborate Effectively to Maintain Accurate Version Control
Keeping track of all the edits throughout a contract negotiation or drug application is a difficult task when you are managing them manually, and in today’s environment, remotely. The key for pharmaceutical organizations to effectively manage version control is to use a digital contract management solution that tracks changes by user and allows them to simultaneously review, redline, collaborate on, and approve contracts directly in the system. This ensures you avoid missing, duplicating, or using inaccurate data that can result from emailing back and forth and comparing different versions between contract manufacturers or other suppliers, CROs, PBMs, physicians, etc.
5. Define and Automate Workflows for Business Process Management
It’s very common for there to be many steps and stages throughout a contract’s lifecycle whether it’s a CDA, clinical trial agreement (CTA) or other agreement type. To keep things moving smoothly, it’s important to have well-defined and documented business processes that are followed and enforced using workflows. This ensures governance and compliance to your processes as well as regulatory ones such as Title 21 of the Code of Federal Regulations (CFR).
6. Use Electronic Signatures to Speed Up Approvals
Securing contract approvals is one of the slowest parts of contract management for most pharmaceutical companies. Using e-signatures to speed up the approval process is one of the keys to pharmaceutical and biotech contract excellence. You can get documents signed and executed electronically from anywhere very quickly and it improves the user experience of the signatory. E-signatures are also an important component of ensuring FDA Part 11 compliance.
7. Establish and Benchmark KPIs with Reports and Dashboards
Reports and dashboards are key for pharmaceutical companies to measure the success of your contracts, tracking productivity and evaluating performance so you can refine and optimize your process. Perhaps you want to build a report to see how a drug’s pricing changes over time, how long each contract stage takes during the creation and execution of a CDA, or to monitor the performance of contracts associated with a particular CRO. All of this is possible once you benchmark and track KPIs using your contract data and is key to pharma and biotech contract excellence.
8. Demonstrate Regulatory Compliance with Audit Trails
Clearly, demonstrating compliance is critical to all pharmaceutical contract management, albeit increasingly challenging with changing and complex FDA regulations. Contracts play an important role when preparing for Good Manufacturing Practice (GMP) audits, Good Clinical Practice (GCP) audits, demonstrating CFR 21 compliance, and other regulatory requirements. By centralizing all of your contracts and supporting documents in a cloud-based repository that’s searchable and reportable you will have a complete audit trail tied to each agreement which is essential for pharma and biotech contracting excellence.
Given the regulatory pressures, new supply chain dynamics, M&A activity, and other industry-related pressures, effective contract management is an instrumental factor in any pharma and biotech company’s success. After all, legal agreements are at the heart of clinical trials, provide agreements, rebate tracking and other pharma and biotech activities. That’s why pharma and biotech contracting excellence is a key focus for these organizations and by implementing the strategies in this blog you will be well on your way to achieving it. Contract management software from Contract Logix makes all of this possible in an automated and streamlined way. Our solution will help you achieve pharma and biotech contracting excellence in fairly short period of time.
Interested in learning more? Talk to one of our contract management pros.