The pharmaceutical industry must manage compliance with a complex and evolving set of regulations. Life sciences companies are also facing rising commercialization costs, fierce competition, and looming patent expirations. In addition, as smaller companies look to eventually bring their drugs to market internationally, they need to start putting the processes in place now to meet their future needs. These challenges are compounded by increasing pressure to bring life-saving drugs to market faster. This was the case for one of the top 20 companies in the pharmaceutical industry, Boehringer Ingelheim. They struggled with slow, inefficient agreement processes.
Outdated contracting processes ultimately hindered Boehringer’s growth initiatives. Their legal teams created dozens of agreements and contracts daily, and they took anywhere from two weeks to one full month to execute. The delays in their NDAs, sourcing contracts, and healthcare provider agreements had a ripple effect on other areas of the business. In 2016, Boeringer set out to increase productivity and transparency in its signature workflows. They also aimed to ensure compliance with an auditable signature process and to reduce paper usage as part of their “be green initiative.”
The challenges of manual contract processes
Every function within a business requires the negotiation and preparation of contracts, approvals, and signatures. These functions may include legal, HR, procurement, manufacturing, clinical operations, and marketing. Approvals and signatures must be executed on time for business processes to run efficiently.
The contract process doesn’t stop once the document is signed. In the pharmaceutical industry, payments are associated with healthcare provider agreements after a speaking engagement. Some signed contracts are provided as part of a drug rebate program. On the back end, systems need to be updated, and documents need to be archived into a repository. All documents must be managed with the ability to search for and analyze information quickly and efficiently. Particularly in regulated use cases, the repository needs to follow GxP guidelines and also be auditable.
Boehringer’s contract lifecycle process looked similar to many life sciences companies. The business created dozens of contracts daily, requiring signatures from multiple parties. Sometimes, those parties are located hours from one another, ranging from Brazil to the Middle East, Turkey, and Africa. Like many companies, they had a manual signature process that looked like this:
- Creation of a final drafted contract, usually by hand.
- The legal sender emailed the contract to the first signer.
- The signer received the contract, reviewed it, printed it, and sent it back out to receive a wet ink signature.
- The signed paper document was then scanned and thrown away, contributing to more waste.
- The electronic version was then attached in an email and sent back to the legal sender.
- The legal sender would then send the contract to a second signer. The process would then repeat until every internal and external signature was obtained.
Not only was this process lengthy and tedious, but the original sender was responsible for tracking every step of the contract workflow. This meant tracking and logging who the contact was sent to, how long each signature took to obtain, and who the next signer in the process was. Tracking these steps was difficult, especially for documents sent via snail mail.
Between the manual activities and global nature of the signatures needed, it’s obvious why it took an average of thirteen business days to fully execute a contract. Boehringer’s legal team decided to take action when they realized the impact of this inefficient process. They decided to revamp their document process with technology to achieve efficiency, cost reduction, and sustainability.
How e-signature can help
While Boehringer set out to fix their document lifecycle process, the overarching goal was to get life-saving drugs to market faster. With that goal in mind, they worked backward to figure out which processes were the most delayed.
Boehringer’s legal and compliance department determined that their signature processes needed to be more agile in order to speed up drugs getting to market. The biggest bottlenecks were in foreign countries like Brazil. Attorneys were traveling hours to receive one wet ink signature.
Not only was this wasteful and time-consuming, but it also offered poor visibility into the signature workflow. Visibility issues had consequences down the line because all signatures and approvals required audits. The legal team was consistently producing contracts that took anywhere from two weeks to a month to be fully executed. It was clear that in order to reduce waste, they had to digitize their processes.
Electronic signature used by 5,000 users across 80 countries
Boehringer Ingelheim started a small pilot with DocuSign. In just two years, they expanded to 5000 users in over 80 countries. Boehringer is a prime example of how DocuSign can be globally deployed while complying with various global regulations. Boehringer chose business cases in countries like the US for sourcing multiple business documents. They chose countries like Brazil, Turkey, Africa, and smaller middle eastern companies for healthcare provider contracts. These business cases were specifically selected because of their high volume, or overall enthusiasm for implementing electronic signature.
DocuSign enlisted a Portuguese speaker to train staff in Brazil. While this was necessary and beneficial for Boehringer, it also made DocuSign aware of how agile they were required to be in responding to changing global needs of their clients.
Quickly after the DocuSign rollout, Boehringer saw the following results:
- An 88% reduction in errors
- Improved turnaround time from thirteen days to three
- A 6X increase in productivity
Boehringer experienced some unexpected outcomes as well:
- They eliminated the need for attorneys to drive to hospitals and institutions to obtain wet ink signatures
- They were able to eliminate the need for witness signatures as a whole in Brazil
- The HCP processes became streamlined between Brazil and the Middle Eastern regions
This initial rollout gave Boehringer evidence and confidence that DocuSign would be accepted and adopted by their employees and partners all over the world.
Key to adoption of eSignature globally, particularly for a German company with some of the strictest eSignature laws, was the fact that Boehringer Ingelheim’s corporate legal department has made a statement to all employees that “DocuSign’s comprehensive approach is considered by the company to be secure and ensures security, privacy, compliance and enforceability of our transactions.”
Boehringer’s best practices for a DocuSign rollout
- A central hub made up of Boehringer employees was established called “The Center of Excellence.” They became responsible for managing the roadmap, support model, enablement strategy, and training for DocuSign. Employees involved in executing the first use cases served as the foundation of the Center of Excellence to train others during their implementations.
- A process was set up where employees throughout the company could submit business cases as requests to use DocuSign. A Word document form was created and posted it on the Boehringer website for easy access. Once applications are received, the business cases that yield the highest ROI are prioritized.
- Seeing quick results from the small pilot, Boehringer moved beyond eSignature. They began to incorporate various business documents submitted by clients for internal and external signatures and approvals. These documents included letters and forms, many of which need to be filled out using text fields, dropdowns, checkboxes, etc.
- Training materials were produced and posted on an internal website giving employees easy access to instructions, guides, and resources.
- “Discover Docusign” days were implemented company-wide to bring awareness to the solution and how it could positively impact their jobs.
Hear more about Boehringer’s implementation of DocuSign, and read A Modern Approach to Compliance in Life Sciences to learn more about the DocuSign Agreement Cloud for life sciences can help streamline compliance processes.
Life Science companies are now prioritizing digital transformation, especially those with global reach. Boehringer realized the necessity to make processes more efficient and reduce waste, all while complying with pharmaceutical regulation and compliance law. While they initially set out to optimize their signature processes, they soon realized that electronic signature technology could encompass all document approval processes. The results were reduced contract turnaround times, increased productivity, and going green, all while remaining compliant for audits. What started as a small pilot quickly grew to a global initiative that made jobs easier for hundreds of Boehringer’s employees and customers.