Compliance is a term that gets thrown around a lot these days, but what does being compliant in the world of biopharma partnering really mean, and why does it matter?
At its heart, compliance is all about protecting your company’s reputation as a trustworthy and professional partner. When partnering, your reputation can make or break a deal. We’ve seen in other industries the damage to your reputation can wreak. Remember Facebook & Cambridge Analytics? Nearly half of social media users still view Facebook more negatively today than before the scandal, and 37% use Facebook less as a result.
The pharmaceutical industry is no different. Reputation matters—that’s where compliance comes in. Compliance ensures that you respect your partners and fulfill their expectations regarding data integrity.
Policies and Procedures
On a practical level, achieving compliance means that there must first be a compliance process in place. For example, consider how documents will be exchanged, where data is being stored, how confidence is being assured, and how all of this is tracked.
As a partner sharing valuable information you can ensure that your intelligence is protected by signing a nondisclosure agreement. You then trust that your partner follows regulations and only accesses confidential packets during a certain period. Failure to comply with these regulations can damage your relationship and bring a permanent halt on negotiations.
Once a process is defined and in place, there must be a procedure to implement it. With the proper solution provider, compliance can be handled by an internal management system. Compliance software not only provides a secure place to create and manage opportunities and store data, but it can ensure compliance to reduce risks, costs, and time associated with manual procedures.
Leveraging Compliance Software
When choosing a compliance software there are a few things to look out for including alerts for documents that must be destroyed, the capacity to track and prove compliance, and the capacity to prevent IP contamination.
For instance, when it comes to CDA agreements, documents are required to be destroyed once their lifetime is up. If these documents are scattered all over the place in email chains, stored on personal computers, or stocked in various shared folders, it’s an almost impossible challenge to ensure they are entirely destroyed. If instead these documents are stored in a central system, they are easy to track and manage and destroying all copies is the work of seconds, not days.
At Inova, for example, we’ve tackled this by offering users both a central space to store and share confidential documents, plus we’ve added notifications and reminders with the remaining time left in their agreement. This automated time bomb makes it easy to respect the constraints of a CDA and remain compliant.
It’s also crucial to apply a mechanism that mitigates the risk of IP contamination. Again, with specialized compliance software, once the tools and policies are in place it's just a matter of engaging them.
Problems With Old School Compliance
While compliance software tools are increasingly the preferred option in the biopharma industry, there are still some companies that are hold-outs, preferring to tackle partnering compliance issues manually the same way they always have. The many complications that come with managing compliance manually, however, are something to consider amidst the increased scrutiny from drug regulators. With stories in the news linking biopharma stock market woes with basic compliance issues, taking action to avoid these shortcomings is crucial.
When inspectors request evidence of regulatory compliance, for example, it is far easier to release what has been tracked with compliance solution software. Inova users often praise the ability to grant access to confidential documents to designated users. Configurable access controls ensure that the documents are not accessible to the whole company but only those that require them. The audit and user activity logs can serve as evidence upon inspection, something that a manual compliance process cannot easily tender. With the growing headwinds on compliance, it’s important to employ reliable tracking methods.
Strive to be a Partner of Choice
The heavy price for failed regulatory compliance is one that goes beyond fines and trials. Failure to abide by these obligations compromises a company’s credibility and its reputation in the industry. By investing in a compliance software solution you can proactively avoid these complications and, concurrently, build your reputation as a partner of choice.
By being intentional with your compliance and data security policies, potential partners will be more open to collaboration without fear of data leaks or data corruption. In return, you win greater visibility and trust within the industry and open the door to opportunities you might not otherwise enjoy.
This article was originally published on LinkedIn on October 16th, 2019 by Nicolas Jouven, Key Account Director at Inova Software.