4 areas information can be better used to improve the chance of commercialization success.
A CRO (Contract Research Organization) is a blanket definition for a business that supports a pharmaceutical, biotechnology, or medical device company in any number of outsourced research-based activities. While the definition can be quite broad, and oftentimes the services rendered are as equally broad, the ultimate goal of any CRO remains very similar; to reduce the cost and accelerate the commercialization of a new drug or medicine to market.
In this blog, we are going to look at some of the main disciplines of CROs including; Development, Pharmacovigilance, Pre/Clinical Research & Trials, and Commercialization; and where information can have a direct impact on their performance, and ultimately, the speed with which they can get a new drug or medicine to market.
Drug development
The first phase of the new drug or medicine lifecycle isn’t one that traditionally CROs had much involvement with. But more recently, they are becoming common players in this space with expertise from target identification and validation, all the way through to preclinical toxicology testing. The reasons for this are obvious. While the average cost of ‘drug-to-market’ is disputed, it is widely documented that it is eye-wateringly expensive (estimates between 1.3 to 2.8 Billion USD) and equally as unlikely in its success (1 in 5000 chance). If a CRO can even slightly increase the likelihood of success while decreasing the cost of the development phase, they’ve already proved their worth.
Information can play a critical role in this – but only if it’s harnessed effectively. With the rate of pharmaceutical publications skyrocketing, it is becoming increasingly important for a CRO to have an information solution that can provide oversight of the drug discovery and development landscapes from a wide-range of sources.
To achieve this requires an AI solution – but not AI in the traditional sense. Here we mean Augmented Intelligence, rather than Artificial Intelligence. What’s the difference? Augmenting intelligence is taking the latest in AI and other technologies and pairing it with the strength of human expertise to get the best of both worlds. This combination can handle the volume and complexity of the information sources needed, while adding another layer of understanding and insight to the information that only a human expert can provide. This ensures that a CRO can keep on top of the constantly shifting landscape without being overloaded by information noise. Ultimately, resulting in faster response times and decreasing the likelihood of critical information being missed.
Pharmacovigilance
Another primary role of CROs is providing Pharmacovigilant support to their sponsors. This means having accurate and timely access to a range of scientific, regulatory, and political information sources – globally. The challenge comes from the vast number of different content sources; both open-source (including health authorities, regulatory sites, and government publications) and premium (such as regulatory journals and drug pipeline aggregators) that need to be assessed regularly to ensure nothing has been missed.
Equally, it’s not only finding the necessary information that is key – it’s ensuring that the information can be passed on to the appropriate stakeholders within the organization. This often means manually collating, analyzing, and disseminating key information to the appropriate stakeholders, in an extremely time-consuming and difficult manner.
Both of these challenges can be overcome with a technology solution that gives CROs the ability to collate, enrich, and share insights to those within the organization who need them. When done in real-time, this can maximize workflow efficiencies, whilst giving organizations the confidence that nothing has been missed and that those who need this information most are kept up-to-date.
Clinical research & trials
The clinical research process is multi-faceted, involves a range of departments, and takes a long time. It can be a perfect storm of noise and siloed information, leading to data inefficiencies. For a CRO, trying to accelerate a potential drug or medicine through the research process accurately and to the requirements of the sponsor, these inefficiencies can be the difference between success and failure.
Again, information can be both the root cause of, and solution to, the problem. The right information solution – centralizing and unlocking all of your internal data – can help to reduce these data silos across disciplines and business units. This reduces the time spent on duplicate resources, ensures no critical information is missed, and facilitates strategic decision making within the clinical trial process and beyond.
Similarly, a CRO providing support to a sponsor in the clinical trial phases needs to have oversight of multiple pipeline databases to ensure that they aren’t being overtaken by rival products or that alternatives have entered into the market that will supplant the value or relevance of theirs.
The challenge that stems from pipeline databases is that they all speak their own language – with naming conventions for drugs in development often differing wildly, making it difficult to identify analogous or complementary records for the same product provided in separate databases. This poses a major challenge for a CRO which is reliant on full oversight of the pipeline landscape. Overcoming this is possible through a combination of powerful technologies; database federation and taxonomies.
What do these mean? Let’s start with federation. Essentially federating databases means to combine their data into one, searchable database that can be accessed with a single query from one location. Now how do taxonomies help? We’ve already mentioned the problem of analogous records returning multiple false positives or resulting in missed information. With a custom taxonomy you can build your own query language with preferred terms and controlled vocabularies. This means your queries can be built to suit your needs yet still provide a complete set of results, regardless of different naming conventions.
Interested in more about taxonomies? Read our blog here written by our Taxonomy Manager to help demystify taxonomies.
Commercialization
After investing significant time, resources, and money in discovering, developing, and readying-for-market a drug or medicine, one of the final tasks is to make the product viable for the market. This is as complex a step as the previous ones, yet one much more commercially-oriented in its ultimate goal – with a much different information solution required.
User demographics, pricing, market access, distribution, drug pipelines, competitive landscape, sales strategies – these are only some of the critical considerations for successful drug commercialization. For a CRO, it’s a tall order to be across the breadth of information required in a means efficient enough to meet their sponsor’s requirements. This is where an information solution that meets multiple end-user needs across a broad spectrum of information sources and types is key.
As end-user needs, preferences and data requirements vary so wildly, it is critical that the solution provided gives users the ability to personalize their information experience. The specific solution itself doesn’t matter, the idea that one size doesn’t fit all does. For a CRO your technology delivery needs to meet a number of information objectives but ultimately the goal is to provide a solution that facilitates the required strategic thinking in building a commercialization plan.
Conclusion
By incorporating information processes and solutions that can drive efficiencies, reduce the chance of missing critical insights, and improve returns on investment. Becoming data-driven and utilizing information best practices isn’t a new concept. But it is of particular importance to organizations such as CROs – where the margins of success are increasingly smaller and smaller.
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