Global content management part 2: collaboration without boundaries
In this article series on global content management, leading life sciences technology firm Veeva Systems explores the challenges involved in managing regulated content on a global scale. In the first article, we examined the overall issues and new technology designed to help life sciences companies overcome them. In part two, we look specifically at how cloud technology enables efficient, seamless collaboration on promotional materials development across cubicles, across towns and across borders.
Continued from “Global content management part 1: collaboration without boundaries ”
In part one of our series on Global Content Management, we discussed the new “pack” mentality of most pharmaceutical organizations – the increased number of external collaborators and the advantage to those companies that embrace more members of their pack. Collaboration is mission-critical to the survival of pharmacos today, and this is particularly evident with promotional materials management.
Unlike in years past when most work was done in-house, organizations are now increasingly relying on external teams to assist them with the intricate process of bringing a drug to market. Therefore, it’s essential that everyone can work together seamlessly – and compliantly – to get the job done.
Of course, that’s easier said than done – especially when collaborating with affiliates and partners on a global scale, which is a requirement today when developing promotional materials like ads, website content, videos and more.
It’s 11am, there’s a new regulation that affects my promotions. where’s my advertisement?
For most pharmaceutical marketers, the answer to this question is – unfortunately – “I don’t know.” Promotional materials are often caught up in different versions, simultaneously being worked on by many different external partners (think copywriters at an agency or designers at a web firm) and floating between global review and local reviewing committees. So, without a globally accessible system to manage it all, anyone would be hard-pressed to know where that ad is located.
In many cases, life sciences companies are also beginning to execute promotional material development and management globally. However, adapting to local custom and regulatory processes is often done locally, and it may or may not be done systematically. Furthermore, usually a drug is approved for marketing in one country, but still in regulatory review in another. Managing properties such as trade name and generic name at these different stages can get tangled, impacting a definition of a branded piece of content as well as what claims can be made in each region.
“Multinational pharmacos must manage multiple translations of the same promotional piece…”
Another complexity is language translation. Multinational pharmacos must manage multiple translations of the same promotional piece, as well as share assets between advertising agencies, marketing teams, submissions teams and affiliates. It’s critical for all of these groups to be able to collaborate so that materials can be appropriately tailored to individual markets.
According to Senior VP, Global Marketing at Bayer Schering Pharmaceuticals, Ian Talmage, “When it comes to promotional materials, there are dozens of different people touching documents – from internal brand teams and operations to writers, designers, and programmers at marketing agencies worldwide. We need a clear audit trail so we know exactly where these content assets go, when, and who they were transferred to internally and externally.”
Yet, trying to share documents with existing processes and technologies is a complicated mess, opening pharmacos to unnecessary risk with too many unaccounted-for versions of a document floating around between company teams worldwide. Outdated technologies force many pharmacos to use workarounds that are barely compliant and, worse, unsustainable.
“Today’s systems have failed to keep up, especially considering the fact that there is a greater expectation of control over the distribution and tracking of content assets,” added Talmage.
Collaborating with ad agencies
Most pharmaceutical companies don’t have the actual promotional assets in house, especially when still in development. So, if they want to make a change, pharmacos must request each document be sent from the agency to the marketing team. This transaction – usually a simple email or FTP site upload / download – is inherently risky for any document that needs to be submitted for regulatory approval. To avoid having content fall into the wrong hands or having multiple, unapproved versions drifting among different groups, pharmacos need to maintain their promotional materials by utilizing a single yet secure system that external teams such as ad agencies can access easily.
“Cloud-based solutions are inherently accessible from anywhere in the world…”
Cloud-based solutions are inherently accessible from anywhere in the world without the hassle of VPNs or other client-side installs, so external team members can be brought on board quickly. Working in a single solution in real time also means users can collaborate on pieces globally and tailor them to individual markets easily. In addition, teams can carry out Medical, Legal and Regulatory review meetings with both local and global teams to ensure they have the correct versions, and stay on top of regulatory requirements.
It must be easy to use
As more and more external teams collaborate with pharmaceutical companies to develop promotional content, these groups will need to be able to easily use a modern content management system. Consider your partners, like ad agencies, who work with multiple pharmaceutical clients. If it takes too long or is too confusing to learn how to use client’s content management system, they will simply not use the system at all. Instead, they will find noncompliant ways to work around it, bringing the problem back full circle. Since there is no way to track or control what happens to the promotional piece once it leaves the system, pharmacos open the door to a multitude of potential compliance-related issues.
According to Steve Hasler, independent consultant and former executive at GlaxoSmithKline, “One of the collaboration challenges is that many of these partners know little or nothing about how to use a content management system. Given this, CM [content management] systems must be simplified so that trusted third-parties – from academia to marketing agencies – will find them easy to learn and use.”
To facilitate ease of use, modern cloud-based content management systems leverage a presentation paradigm familiar to everyone – the consumer web. By using elements from sites like Amazon.com and LinkedIn in a content management setting, cloud-based systems provide a more approachable interface that does not require the level of training typically needed for on-premise or hosted solutions. User adoption is higher, making it far more likely that all collaborators are working together in the same system. Simply put, an easy-to-use system helps ensure pharmaceutical companies stay compliant because their partners are not tempted to circumvent the auditable process.
“…an easy-to-use system helps ensure pharmaceutical companies stay compliant because their partners are not tempted to circumvent the auditable process.”
It must be inexpensive to manage
Life sciences companies require a system that doesn’t take weeks or cost a fortune to add users, especially if the users only need access for a limited amount of time. Existing systems built on aging on-premise client / server platforms lack the flexibility to enable complex collaboration on a global scale. For example, traditional client / server content management systems may require a separate full user license for each external collaborator, which can get very expensive for both large companies and growing biotechs that can’t afford to be saddled with the headache license fees. They might even need to send company laptops. It takes too long, is too complicated and is too expensive to give secure access to tens or even hundreds of external collaborators that are now an important part of the promotional material development process.
Collaborating with global regulatory bodies
Collaborating with external partners to develop promotional materials is key, but collaborating globally to ensure regulatory compliance is just as important. The regulatory approval / withdrawal processes are different from country to country. Again, pharmacos need a single system that allows for different regulatory routes depending on geography. For example, many Italian organizations have a 10-day waiting period before executing promotion ‘at risk.’ In Germany, the #1 drug market in Europe, companies require long audit trails and comment histories to be available indefinitely.
And, making changes to a claim – for regulatory purposes, for example – can be a long, complex process when you consider all of the different promotional materials where that claim is made and all of the locations where those materials are stored globally. By contrast, a single, integrated system allows companies to quickly locate all pieces that use any particular claim and change it in one efficient swoop. A single solution also makes it much easier to track assets – such as multiple translations of the same core piece of content – because it offers visibility into all versions of content.
“Autonomy and self-reliance have been replaced by shared partnerships across nearly all areas of a life sciences company today.”
Modern cloud content management solutions can make changes easy. They can be configured in minutes so that content development is not slowed down by technical constraints, and response to regulatory changes doesn’t slow down the entire marketing engine. With traditional on-premise and hosted systems, any change to the system requires a months-long, costly update. By then, it’s too late.
Global collaboration works in the cloud
Autonomy and self-reliance have been replaced by shared partnerships across nearly all areas of a life sciences company today. The ones that find a way to collaborate efficiently and effectively will have the advantage – especially as markets continue to expand globally. By making it as simple as a few clicks to add a trusted user, they enable ease of administration so life sciences companies can share changing content almost instantly. If something needs to change, whether it’s a new workflow to match a revised strategy or updated regulatory requirements, cloud users can quickly adapt. Updates happen seamlessly, behind the scenes, and new attributes can be configured via an administration panel in minutes. And, because the cloud is scalable, additional users can be added with no additional strain on IT. As many industry leaders are discovering for themselves, the answer is in the clouds – literally.
About the author:
John Chinnici is the Global Director of Product Strategy for Vault PromoMats, the very first end-to-end solution for managing promotional materials. Over the past 15 years, he has worked closely with a multitude of major enterprises across multiple continents. John brings an in-depth understanding of commercial operations and strategic approaches to life sciences companies both big (working with 10 of the top 15) and small.
John has a Masters of Business Administration from Columbia University, and earned a B.S. in Computer Engineering from Penn State University.
Is the answer in the clouds?