Global content management part 1: Collaboration without boundaries
Pharmaceutical companies follow the survival instincts of African wild dogs
Jen Goldsmith
Veeva Systems
In the first of this two-part series on global content management in the cloud, the author outlines today’s new collaborative business model taking hold in the life sciences industry and the effect that it is having on managing content across borders. Like the species of wild dogs that lives in the African savannah, life sciences companies are rapidly increasing the number of external affiliates and partners that they rely on in order to survive a more competitive business landscape. Yet, this new model presents challenges that require a totally new technology…a totally new approach to survival.
Over the last 10 years, the global population of African wild dogs has been shrinking rapidly, to the point of endangerment. However, these clever carnivores have recently started clawing their way back into population using an interesting new survival technique: larger packs. While they have always worked together, they’re now allowing more and more dogs to live together in fewer packs – even within shrinking territories. Lately, it seems life sciences companies are doing the same.
Not long ago, these companies were largely autonomous. Drug development, research, manufacturing and marketing were typically handled in-house. Today, it’s a different story. Over the past five years, the number of external business partners that life sciences companies employ has increased by more than 50 percent! This explosion of new partners into the pharmaceutical landscape – this dramatic increase to the pack – is a fundamental shift for companies who have worked in isolated silos for dozens of years.
This new arrangement is not without its own set of challenges. Like the African wild dog, pharmacos have embraced changing their technique in order to survive. And, while affiliation with these partners – clinical research organizations (CROs), advertising agencies and co-development partners, etc. – has reduced costs and decreased time to market, it has also created significant content management challenges. Most notably is the fact that new members of the so-called pack often work in remote offices around the world and have limited access to tools and resources needed to facilitate collaboration with headquarters and other partners.
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"Like the African wild dog, pharmacos have embraced changing their technique in order to survive."
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To combat these challenges, life sciences companies are increasingly turning to multitenant Software-as-a-Service (SaaS) technology to improve their business process and communications efficiency. These cloud-based technologies give companies the ability to implement and scale a content management solution that can meet regulatory standards and promote safe, efficient collaboration without the burdens of conventional on-premise / hosted systems.
A new pack mentality
More than ever, pharmacos are entering markets far from their home bases due to growth in emerging markets and higher spending by developed nations. In fact, the annual global pharmaceutical spending has been anticipated to reach US$1.2 trillion by 20161. All good news, but with growth, of course, are growing pains.
From safety reports to promotional materials to health authority submissions, much of a life sciences organization’s information is contained in the form of content: documents, webpages, promotional material, etc. And whether it’s communicating new marketing language or updating dosage instructions, affiliates around the world need to be in sync.
But with disparate systems, firewalls and ever-growing, ever-changing sets of local regulations, getting global teams on the same page remains a challenge – especially considering the growing number of external participants. While traditional, on-premise content management systems often support collaboration within the confines of a company, they aren’t designed for external communication. Traditional systems are often difficult and costly to change, and even simple changes require elaborate system validation, development, installation and deployment, which can cost hundreds of thousands of euros.
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"...the annual global pharmaceutical spending has been anticipated to reach US$1.2 trillion by 2016."
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“First, you need to figure out how to give third-party access to your systems across the firewall without making the organization vulnerable,” said Steve Hasler, an independent consultant to the life sciences industry and former vice president of Global Regulatory Operations at GlaxoSmithKline. “Next, you need to figure out an economical and efficient way to get all of your external partners trained to use your system.”
There are also software implementation and training – both time-consuming and expensive, yet necessary, steps. Often, this can take six months or more. That’s too long for life science companies that need to focus on creating and delivering content rather than implementing and validating system changes.
With a true multitenant SaaS application, however, these difficulties largely disappear. This instant access means users can collaborate more easily and quickly than with traditional systems, which is an enormous advantage whether navigating the complex global regulatory markets, or the vast African savannah.
Adapting to new surroundings
Country-specific government regulations affect not only what pharmacos can create, but also how that material can be used. For example, each market may have different application and withdrawal timelines if content must be updated or removed. And if there’s a small change to, say, dosage information, companies must submit separate filings for each country. There are also unique submission processes for regulatory approval of a product or drug. To accomplish this, traditional on-premise / hosted content management systems must be supplemented with various other systems to manage different parts of the process, or to meet individual market regulations. This results in a mesh of disjointed systems – making it far too easy to lose track of which content can be used and where, both core regulatory risks.
Another risk lies in how the systems are actually used. Older solutions weren’t built for the modern user, just compare the usability of a site like Amazon to any traditional content management system for proof. Furthermore, on-premise / hosted systems are often not robust enough to handle many users or large files. So global affiliates, who rarely have significant resources or IT staff, are often forced to use non-compliant workarounds, such as email and file shares, to get anything done – forget about collaboration! And to make matters worse, company headquarters has little to no visibility into their content or business processes.
If companies want to stay ahead and out of regulatory trouble when working with local affiliates worldwide, they need a comprehensive view of how their content is being used. With a multitenant cloud-based solution, companies can use a single system with local instances that can be configured to meet local regulatory rules. A change to the application is automatically made to all instances of that application, but a local configuration will not affect any of the other local instances. It’s global control with local freedom.
In contrast to traditional systems, cloud-based content management technologies can also reduce the time to deploy and validate changes by more than 50 percent. This is because cloud-based technologies automatically receive updates as part of their application structure, are easily tailored to meet changing regulatory requirements, and significantly reduce the time and effort of validation by sharing the burden across all organizations.
“With the cloud, you can make a regulatory change once for all clients, and the costs are spread out rather than every single life science company tackling them on their own,” Hasler said.
Adding new members to the pack
In order for companies to grow and meet global demand, content management systems need to be able to handle the increase of users and content easily. With cloud-based SaaS technology, affiliates and external teams like ad agencies and CROs can be added to the system in about a minute, drastically reducing onboarding times. In addition, because the cloud is scalable, affiliates and external teams can be added to the system without significant IT burden.
“It is incredibly important for new content management systems to be built upon new technology that allows for computing elasticity — that is the real value of cloud computing,” said Ian Talmage, senior vice president of global marketing at Bayer Schering Pharmaceuticals. “Content management systems need a flexible user interface that allows people to add user-generated content so that it can be easily uploaded and shared (but not edited) for regulatory purposes and clinical trials.”
For example, drug safety content might include the message: “This medication should not be used by pregnant women,” which appears in many places, including promotional materials, package inserts, labels and information for medical professionals. If the wording needs to be changed to meet a new regulation, employees need to be able to apply changes quickly across all functional areas.
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"Cost savings is one of the greatest benefits of the cloud..."
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Due to its inherent flexibility and global accessibility, cloud-based content management allows the re-use and re-purposing of content across functional areas so that the document and the information it contains can be controlled, re-used and tracked. Information, therefore, is never ‘siloed’ by job function, but rather made accessible across functional areas.
Survival of the fittest
Cost savings is one of the greatest benefits of the cloud, companies can save anywhere from 30 to 50 percent over traditional, onsite content management systems by eliminating the capital cost of servers, software and maintenance. This is a huge advantage for affiliates that may not have the resources to afford enterprise-level content management systems, nor the IT staff to manage them.
There’s no telling whether or not the population of African wild dogs will continue to grow, but one thing is for sure: they know how to adapt. Like these survivors, life sciences companies have adapted their own business models to welcome a greater number of affiliates and partners from all over the world. It’s a smart business model considering today’s new landscape, but it requires new technologies that are designed to enable collaboration across geographic boundaries and regulations. With a single, cloud-based global content management solution, companies can truly support this model so that it works both in theory and in practice.
References
1. IMS Institute for Healthcare Informatics. The Global Use of Medicines: Outlook through 2016. Publication: July 2012. Accessed via: URL: www.imshealth.com.
The next article can be viewed here.
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About the author:
Jennifer Goldsmith is the Vice President, Vault Strategy and Services at Veeva Systems. She has honed her skills for regulated content management over the last 15 years by working with clients such as Johnson and Johnson, Pfizer, Shire, BMS, Roche, and with industry leaders such as IBM and CSC. Jen has created strategies and solutions in business areas across the life sciences value chain, including research and development, regulatory submissions, manufacturing, and promotional materials.
Prior to joining Veeva, Jennifer was a leader in IBM’s Life Sciences Global Business Services Practice, where she was responsible for managing a global consulting team focused on life sciences technology innovation and implementation. During her 6 years with IBM, Jennifer was responsible for some of the industry’s largest and most complex content management programs, as well as for the development and deployment of a number of business solutions.
Jennifer was recently named to the PharmaVOICE 100, which recognizes the 100 most influential people in the life sciences industry. Jennifer graduated with honors from Cornell University, with a Bachelor of Arts degree in Psychology.
Can SaaS technology improve business processes and communications efficiency among worldwide teams?
