The publication of ICH E6(R2) prompted pharmaceutical and life sciences organizations to reconsider their approaches to insourcing and outsourcing, with a particular eye on clinical development analytics. More specifically, the ICH revision places greater importance on vendor oversight and traceability in metrics-driven decision-making.
In response, customers have wanted to know if they really understand their own analytics, whether they can trust them when making regulated decisions, and if they are ultimately using data in a way that promotes subject safety. No doubt, there are more solutions than ever for leveraging analytics, from visual tools to cloud-based collaboration suites, along with the option to either insource or outsource analytics strategy.
A contract research organization (CRO) or other data vendor can handle the outsourcing, but insourcing may be preferable for giving internal users direct insights. It’s also possible to synthesize the two approaches in a hybrid paradigm.
The right path will depend on the particular needs of your organization and project:
- First, determine what you should do in the context of the evolving regulatory environment and the rising salience of data analytics.
- Next, evaluate your organizational needs and culture. From there, you can begin choosing a way forward.
Selecting Your Ideal Path
Start by assessing your current setup. In other words, are you making the most of the data you already have? Many clinical organizations have a bounty of clinical data at their disposal, from which they can extract insights for more efficient trials and improved subject safety. But in numerous cases, there is considerable room for improvement. Examples include incorporating analytics from a vendor and combining them with in-house reports, or upgrading to more user-friendly dashboards.
At the same time, realizing this untapped potential can carry some risks. It’s important to feel confident that the data you collect and serve is of sufficient quality to support the decision-making across workflows like medical monitoring and clinical operations. Moreover, you should know who has reviewed the data and the subsequent actions taken.
Visibility into the sources and uses of this data is particularly important if you work with an outsourcing partner. Indeed, post-ICH E6(R2), many sponsors are more focused on tracking all user interactions with data and any resulting decisions. That’s only possible with enough transparency into how analytics are made and consumed. Bringing things in-house can be a good way to bolster such oversight and simplify compliance.
Considerations for Insourcing
After thinking about the ideal path, determine if your team is ready or needs more time. Let’s say you’ve opted for insourcing. Here’s what to figure out right away:
Avoid trying to solve all of your problems at once. Instead, start somewhere specific, e.g. by identifying the two or three departments that would benefit the most from analytics implementation. In practice, that might look like a group of medical monitors needing better oversight of safety signals, or an ops team requiring more accurate tracking of site-by-site risks.
Find out if any of your internal users have experience with visual analytics. If they do, this expertise can give you a head start in developing your data strategy.
Insourcing works much better when you already have thorough knowledge of your data sources.
- Where are they located?
- Are they accessible?
- Who can use them?
Knowing the answers to the questions before you begin will save you trouble later on with your insourcing approach.
Considerations for Outsourcing
What if you’ve decided that it’s better to work with outside partners in some capacity? There are good reasons for doing so, including a compelling partner offering or lack of in-house infrastructure and personnel to handle insourcing.
Look for a vendor with a fully-managed platform. That way, users can harness the power of visual analytics without needing extensive technical expertise. Check that the vendor also has the proper domain focus and reputation. You should also make sure they can deliver solutions that are tailor-made for your specific requirements, so that you don’t have to spend more time and money on customizing tools like business intelligence (BI) platforms.
Assess the readiness of your users before finalizing any outsourcing decision. If they can get by with an existing tool, that setup may still be more cost-effective and practical than switching over to an external provider.
For more information, read the white paper “Adapting to the Medical Monitor.”