Future proofing your outsourcing strategy

The biopharmaceutical industry is at a critical juncture, poised for exponential innovation and transformation, similar to the revolutionary advancements witnessed in the automotive industry during the Industrial Revolution and the more recent growth in the information technology sector.

Choosing a pathway to innovate for the future

After decades of incremental progress in clinical trial design and execution, the necessary technological, regulatory, and talent infrastructure is now in place to enable accelerated innovation adoption, as shown above. 

Similar to the automotive and IT industries, to remain competitive, the biopharma industry must move past traditional stepwise development and adopt more agile approaches. For example, a solid foundation in randomized trials, data governance and ethical standards needed to be in place for us to establish informed consent to protect patients and now, to understand how to handle AI.

Future proofing: building agility for tomorrow’s uncertainties

With a wealth of untapped potential and innovations ready to be implemented, how do we adapt our outsourcing strategies to leverage these advancements?
The key is to build an agile outsourcing strategy that allows for adaptation of the operating model as needed. This approach requires a holistic view, considering all functions within the organization and the interconnected nature of the industry. Whether opting for a full-service model, an FSP approach, or a bespoke solution, biopharma sponsors must prioritize their desired operating model while weighing the limitations and benefits of each approach. 

Structuring your partnership for success: Moving beyond outsourcing labels

The choice of model is often based on whether companies would prefer to adopt technologies and systems to gain more control over data and become more agile. This requires companies to decide whether they would prefer to handle the constant technological evolution internally or rely on partners that have an established infrastructure and can adapt, and update technologies as needed and at the necessary pace.

Biopharma companies should consider the following when building an agile outsourcing strategy:

1. Internal capabilities and resources
2. Complexity and scale of the clinical trial(s)
3. Level of control over specific functions
4. Budget considerations
5. The need for flexibility and scalability
6. Specific therapeutic area and phase of development
7. Whether they prefer to invest in technology 

Ultimately, the goal is to help companies strike a balance between maintaining control, leveraging external expertise, and staying technologically current in an increasingly complex clinical research landscape. Leveraging a CRO’s outsourcing expertise and scale can help companies identify opportunities to optimize their approach, helping turn fixed costs into variable costs without sacrificing quality.

Embracing change for success

The wealth of untapped potential and innovations ready to be implemented is vast, ranging from patient recruitment and retention to data analysis and trial design optimization. 

Technology is increasingly being applied to drive efficiencies, such as predictive analytics to drive site selection, real-time monitoring of protocol compliance and patient data, and automated operational workflows. This shift signals the move toward a more integrated and holistic approach in which technological solutions cross functions and businesses, breaking down traditional silos. 

There is a growing recognition of the need for centralized solutions that can eliminate these silos, enabling seamless communication and data sharing across various stages of clinical trials. As a result, outsourcing strategies are evolving to prioritize partnerships with CROs and technology providers that can offer comprehensive solutions that span the entire clinical trial process, from protocol development to regulatory submission.

There are many examples of once-dominant companies that failed to adapt to technological and market shifts. To avoid failure, the biopharma industry must overcome the fear of change and embrace innovation. The foundation for transformation is in place, and now is the time to accelerate adoption of innovative approaches in clinical trials and outsourcing strategies.
 

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