Anyone in the drug development industry who has recently attended an industry conference, browsed a trade publication or even opened an email is likely to feel overwhelmed by the proliferation of proffered technology solutions. Parts of the development process, such as clinical data management and regulatory documentation, have been relying on technology as their primary means of conducting business for some time now, but it’s beginning to feel like every possible activity has inspired the creation of a device or a digital solution. It’s a rare clinical vendor that doesn’t offer technology to support its services.
Although this rapid expansion of options brings the promise of better and faster drug development, it also can be a bit dizzying. Even the most cost-effective technology solution is not cheap. In addition to the hard dollars needed to purchase or subscribe, the behind-the-scenes costs can be substantial, too. If a solution does what it is supposed to do out of the box, there can still be considerable expense related to systems integration, training, organizational change management, grandfathering ongoing work in legacy systems and maintaining end-user support. And investments of time, money and human resources can skyrocket if the technology solution is not yet as ready for prime-time as may have been expected.
Biopharma companies deciding how to invest in new technologies are required to be more sophisticated than ever. The playing field now includes non-traditional providers who are finding ways to bring their experience around cloud, digital and big data into the drug development space. And the lightning-fast pace of innovation can make it even more challenging to ensure adequate protection of patient privacy, data integrity and compliance with regulatory requirements.
Companies of any size need to answer the following questions to make sure they’re making the best decisions around their technology investments:
- What is the business problem you’re looking to solve? Until you can clearly articulate this, you won’t be able to drive decisions with internal stakeholders—and you will run the risk of unintended scope creep once your project gets started. Make sure you can also state exactly where this project falls on your organization’s IT roadmap so you get the most out of the investment.
- How business-critical is the system or process you’re looking to upgrade or replace? Knowing how a new solution might impact your ability to conduct business will help you understand how much risk you can afford to take. Assess upfront whether your desired solution has to be fully operational the day you flip the switch—in which case it had better be well-proven and fully supported—or if you can afford to try something more innovative.
- What are the main drivers of your business case? Are you looking for something faster? Cheaper? More user-friendly? Many different factors contribute to your competitive position. Decide what is most important to your definition of project success, and let that influence decisions around cost, features and the best path to implementation.
- Who are your key stakeholders? All change requires champions, but this is especially true for technology change because of how it impacts the way people conduct their work. Initiatives like these always benefit from the guidance of a steering committee, which would ideally include leadership from the relevant operational functions as well as appropriate expertise from IT, Finance, Procurement and Quality. Also consider a test-user group selected from your target end-user community. These people can provide important input about desirable vs. superficial features and valuable feedback when it comes time to test the solution. They can also become your change ambassadors when you begin implementation.
- How much time, cost and human resource commitment are required to get your solution fully up and running (and integrated with your other systems)? Remember that every unplanned change you make once your project starts is going to have costs. Make your initial planning as robust as possible, but be sure to build room into your budget for the inevitable and unexpected changes that come up along the way.
- How much time and resources are going to be needed for due diligence? Your procurement team can be a rich source of information about the marketplace. As part of due diligence, be sure and request “live” demos of capabilities (as opposed to static presentations) and request as much historical performance data as the vendor can provide. Complete a thorough reference check that includes industry peers. Document everything that leads to your final decision. Scorecards are a great way to quantify information, but also be sure to keep copies of presentations, evaluations, meeting minutes and relevant emails. This information will be invaluable should you get audited at some point in the future.
Beginning the technology selection process with the end in mind is the most effective way to ensure a wise investment. Whether you have short-, medium- or long-term goals, the right processes will be key to your success.
ISG’s Clinical Sourcing Advisory team provides the tools, benchmarks and expertise to help development functions assess and improve their selection and implementation of technology solutions. I’ll be hosting a session related to this topic at the Partnerships in Clinical Trials Conference in Boston October 5-7. Look for me there or contact me directly to set up a time to talk.
About the authorFran works with global and regional biopharma and contract research organizations to streamline and optimize all phases of drug development and clinical sourcing. She helps identify gaps in alignment, implement practices that deliver measurable efficiencies and increase the value of outsourced relationships for all parties. Fran provides both broad insight and specific strategic and operational expertise on clinical outsourcing, service provider selection and engagement, service integration, governance, operational excellence and utilization of metrics.
