Thursday, August 11, 2016

Navigating the Maze of Development Technologies: Some Best Practices

by Frances Grote, Practice Lead, Clinical Sourcing Advisory, ISG 

Anyone who has recently attended an industry conference, browsed through a trade publication or, for many of us, opened an email might well feel overwhelmed by the proliferation of technology solutions in the drug development space. Parts of the development process have been relying on technology as their primary means of conducting business for some time now, but it’s beginning to feel like every activity you might think about doing has inspired the creation of a device or a digital solution. It’s a rare clinical vendor who doesn’t offer technology to support their services.

Although this rapid growth of options brings the promise of better and faster drug development, the extensive choices in the marketplace can also put sponsors at a disadvantage. Even the most cost effective technology solution is not cheap. In addition to the hard dollars that have to be invested to purchase or subscribe, there are substantial behind-the-scenes costs: systems integration, training and organizational change management, grandfathering ongoing work in legacy systems, and maintaining end-user support. And those are the costs if the application does what it’s supposed to do pretty much out-of-the-box. Investments of time, money and human resources can skyrocket if the technology solution is not yet as ready for prime time as everyone predicted.

Additionally, sponsors making a decision to invest in new technologies are required to be ever more sophisticated in their selection process. 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 ever more challenging to ensure adequate protection of patient privacy, data integrity and regulatory considerations.

There are some key actions sponsor organizations of any size can take to ensure they’re making robust decisions around their technology investments:

What is the business problem you’re looking to solve? It seems like an obvious question, but until you can clearly state this, you won’t be able to drive decisions with internal stakeholders – and you run the risk of unintended scope creep once your project gets started. Closely related to this is the next question – where does your project fall on your organization’s IT Roadmap? You probably don’t want to start working on anything until you can find that out.

• How business critical is the system or process you’re looking to upgrade or replace? Make sure you fully understand how a new solution might impact your ability to conduct business, because that will dictate 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 for sites and/or patients? There are many different factors that contribute to your ability to stay on the competitive edge. Decide which of those are most important to your definition of project success and let those help drive decisions around cost, features and the best implementation pathway.

• Who are your key stakeholders? All change requires champions, but technology changes in particular, because of how they impact the way people conduct their work, need to have strong support from the right people, right from the start. 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 eventual end-user community. They can provide great input about desirable vs. superficial features and important feedback when it comes time to test the solution. They can also become your change ambassadors when you begin implementation.

• Plan upfront for the time, cost and human resources that will be 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. You want your initial planning to be as robust as possible. Even so, some unexpected changes are likely to come up along the way. Be sure to build room for those into your budget.

• Allocate sufficient time and resources for due diligence. Your Procurement team can be a great resource in terms of helping you plan for this, including providing you with a rich source of information about the marketplace. As part of this process, 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. Do a thorough reference check that includes industry peers. Finally, it’s important to document everything that leads to your final decision. Scorecards are a great way to quantify information, but be sure to keep copies of presentations, evaluations, meeting minutes and relevant emails as well. 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 mechanism you have for ensuring a wise investment. Whether you have short-, mid-, or long-term goals, using the right processes to get there is 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. Contact Frances Grote at for further information.

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