Regulatory publishing is the backbone of any pharmaceutical, biotech or medical device business. Here we review the factors to consider around bringing publishing activities in-house as this important milestone is reached.
How do you know it’s time to bring regulatory publishing activities in-house?
The outsourcing model for regulatory publishing – where external experts and a publishing workforce are hired to meet changing requirements – is typically used by startup biotech and smaller pharmaceutical enterprises that have only a few submissions to make around initial clinical trial filings, and perhaps a small number of new drug applications and/or variations.
Eventually a time will come when bringing a publishing solution in-house makes financial and operational sense. Typically, this will be when:
– You want total control over the timing of your submissions
– You need more agility to respond to the demands of the evaluating authorities
– The return on investment of an in-house publishing platform is sufficient and makes sense in view of the larger expense of continued outsourcing
“Rather than having your new publishing team flying solo at possibly the most critical time for your business, it is best to ensure that an experienced publisher is on hand to assist and advise.”
– Sandra Vignes, Solution Consultant Director, Calyx
Important factors to consider when evaluating in-house regulatory publishing solutions
When investing in an in-house publishing solution it’s essential to work with a provider who not only understands regulatory complexities, but who also brings together best of breed systems that evolve to meet evolving, global regulatory requirements.
It goes without saying that you’ll want to obtain a full description of the security standards to which the proposed solution complies, to ensure that your highly sensitive information system is protected. And, of course you’ll want full transparency into the provider’s charging model ‒ whether it’s unlimited or transactional, where you pay every time you press the “Publish” button (the latter is much more restrictive and can inhibit iterative publishing).
As you research and view demonstrations of the myriad publishing solutions on the market today, consider the additional factors presented below and ask the questions outlined for each so you can make a fully informed decision and have confidence that the system you select will benefit you now and as your needs for regulatory information management grow.
System robustness
The length of time a system has been on the market can be an indicator of its robustness and the depth / breadth of the functionality offered. It reflects not only the amount of rapid regulatory changes the system has seen, but also the degree of user input that has been built into the system over time.
How to gauge system robustness
- One measure of a solution’s robustness and versatility is the number of countries where it is used. Although you may not think you need a global solution now, the expense and risk of moving to a different system with more global capabilities in the future is always substantial, so it’s a good idea to begin as you intend to continue.
- If during the outsourcing phase you encountered any technical issues, ask to see how these would be overcome during the solution demonstration.
- Check that the proposed solution will accommodate both the jurisdiction(s) in which you intend to submit (DTD specification) as well as the specific submission requirements and regulatory pathways around the type of drug or medical device.
Training delivery
Key to the success of any system implementation is user acceptance. Good training produces confident users who embrace the system because they understand how it can enhance their day-to-day tasks and make their job not just easier, but more fulfilling and productive.
There are various approaches to delivering user training – make sure you fully understand the solution providers’ approach to ensure it will meet your team’s needs.
Questions to determine training delivery effectiveness
- Is it delivered by the vendor’s in-house, dedicated training staff?
- Is it instructor-led, or eLearning, or a blended approach? Often, a blend of ‘just-in-time’ training in person, along with access to eLearning for longer-term reference, is a great choice.
- Can the vendor provide a service to help you decide on the optimal training choice?
- Can the vendor provide train-the-trainer services?
- Does bespoke training make sense?
- Is training in support of system upgrades included in the subscription price?
User support
Make sure that you understand what assistance is included in up-front implementation activities and in the ongoing subscription. In order to ensure success, your staff will require more than just system training. Rather than having your publishing team flying solo at possibly the most critical time for your business, it is best to ensure that an experienced publisher is on hand to assist and advise.
Questions to evaluate support availability
- Is support for your first submission included?
- Does the vendor offer the services of a validation expert to help you through performance qualification / UAT?
- Does the vendor provide advice from experts on the impact each system update will have on your busines?
- Is support charged on a “per call” basis; or is it provided 24/7?
Technical support
Check that the prospective vendor’s technical support staff understand what regulatory publishing is, and how critical your activities are. This will give you a gauge of how available their support will be as you work to get your submission out the door.
Questions to gauge technical support access
- What Service Level Agreement is offered?
- How can Technical Support be contacted?
- Where are support staff based?
System scalability
The costs and risks involved with migrating to a full-size, full-strength system should not be underestimated, so be sure to understand how the system can be expanded, as well as how easy an expansion would be. It is prudent to understand the logistics, complexity, and business disruption associated with system expansion.
Ask the provider if they can easily expand to include additional features as your business grows, such as:
– Document management system (DMS) integration
– Additional publishing regions
– Regulatory information management functions including XEVMPD and IDMP
Cloud vs. on-premises
Cloud-based systems offer significant benefits over those that are hosted on-premises. They greatly reduce the burden and cost of maintaining multiple software applications or dealing with managing multiple vendor solutions, versions, and integrations. And, with cloud solutions you only need to perform UAT to meet validation requirements, instead of purchasing, installing, managing, validating and updating software, including third party licensing, as well as the infrastructure on which it runs. With a cloud-based system the burden of validation activities is typically reduced by 80% when compared to an on-premises installation.
Cloud-based systems enable you to put more resources toward getting your drug or medical device to the patients who need it.
Conclusion
Bringing regulatory publishing in-house is a clear indication of expected ongoing success and growth, particularly of likely first financial returns for shareholders from an expensive development program.
In the midst of this exceptionally exciting time it’s critical to ask the right questions to ensure your selected system meets your current and future needs.
