Building your digital infrastructure from start-up to commercialization

Picture it - it’s been years since your vision of bringing a new therapy to market was set in motion. The team was small with an immediate focus on the product development stage. As the clock ticks away, the clinical trials have progressed, regulators are heavily engaged and you can see the possibility of your product impacting the lives of patients within the next two to three years. The focus must now shift from development to organizational readiness for product commercialization – but where do you start?

Taking a closer look into functions, processes, and infrastructure – it’s important to understand the path forward and be aware of risks along the way. In general, commercial readiness can be a daunting task for a small team and as those teams expand with the functional build-out, there is the risk of fragmented thinking and planning. From IT infrastructure to compliance across functions, standard operating procedures and more, we have seen how teams struggle to achieve alignment and this often leads to delays and over or underinvestment of capabilities. So how can emerging biotechs successfully carry out this tremendous undertaking? Having the right partner at the right time with the right framework to guide and implement your roadmap across functions and respective requirements can be the key to ensuring successful commercial readiness. 

Who is the right partner?

In choosing the right partner for your organization, you should first ensure they have a structured model or framework to guide your thinking and planning and help plan, implement, test, and validate your digital infrastructure - which will be the backbone upon which the organization functions. Traditional functioning organizations with bare minimum digital or IT capabilities are becoming a thing of the past. If the pandemic era taught us anything, it is that organizations of the future must be digitally enhanced from the inside out. Emerging biotechs are beginning to leverage digital capabilities from very early stages – giving them an advantage as they have a blank slate to design their capabilities and agility for optimal efficiencies and collaboration. The best partner for you is an experienced one who understands the lifecycle phases, and the benefits of long-term design and plan to fit your needs as you mature. Such a partner will seek to understand your strategy and help design the best operational model for optimal execution. In addition, a value-add partner also helps you embed and align agile ways of working with the digital infrastructure.

A partner with a pulse on industry trends

The fundamental advantage for emerging biotechs is making critical long-term operational decisions that involve the entire value chain from R&D to patient engagement. From an IT perspective, these decisions should align with the current industry trends, and your ideal partner should understand and help direct plans that align with those trends including:

• Becoming digital to meet customer expectations
• Protecting data and equipment through cyberprivacy and cybersecurity
• Meeting all regulatory compliance
• Harnessing the power of data analytics to improve business and patient outcomes and reduce cost
• Building interoperability of systems to allow collaboration across boundaries of the organization

Accomplishing these five objectives not only sets up the digital organization of the future but sets a strong competitive edge, internal efficiencies and best-in-class collaboration – making the siloed walls rather invisible.

In Summary

The value partner will be a trusted advisor and an integral part of your team, enabling your digital infrastructure readiness to stay ahead of the curve as the organization matures.

Where are you in your maturity stage?  Start-up, clinical stage or heading to regulatory approval?  With a strong and trusted partner, leaders can focus on the strategic imperatives all while knowing that their full enterprise digital infrastructure will be met to serve an agile supply chain, deliver products on time, support customer-centricity and support the patient journey for optimal outcomes.  Reach out for a conversation and let us guide you with our tested framework that illustrates the trigger points for digital that supports the business needs and help you stay ahead of the game.

For more information, or to learn how CGI can help you ensure commercial readiness in your organization, visit our commercial operations excellence center.