Success is in Leveraging People and Process - Insights from SCOPE

Since I work mostly with small to mid-sized biotech and pharmaceutical companies, I gravitated towards the small biopharma strategies track at this year’s SCOPE conference – the leading industry event for clinical research.

This track covered a wide range of topics reflected in the conference agenda – staffing options, technology, and the benefits of a quality focus, just to name a few. What was evident as being important to small biotech and pharma companies is the need to optimize their people and processes in alignment with their endgame.

On the Path to Optimizing Operational Maturity

Small biotech and pharma companies are often on a journey of optimizing their operational maturity while they are carrying out their crucial clinical trials. As they progress throughout the stages of clinical development, it is imperative they drive performance through a focus on people, process, data utilization, and technology by maximizing their operating model.

This matters because people execute trials while driving growth and innovation, processes ensure consistency and compliance, and strategic alignment is key for sustainable success. However, companies will face challenges when implementing trials, including having limited internal resources, reliance on outsourcing key activities, siloed teams, navigating regulatory complexities, and the ever-present challenge of balancing speed with quality.

Companies will need to focus on several key components to achieve success in their clinical execution. Key components for clinical execution success include:

• Strategic governance system and a flexible, agile culture to incorporate new methods and tactics to evolve ways of working
• Forward critical thinking and risk management
• Strong project and vendor management
• Site monitoring and management
• Strong science and rationale for the why behind tactics

Digging deeper into two of these components, I explore how companies can lean into these components (despite their challenges) by leveraging people, processes, and technology.

Forward Critical Thinking and Risk Management

• Do not build a heavyweight system, instead, ensure the right risks are identified early, monitored intelligently, and acted on decisively—with limited people, budgets, and outsourced partners.
• Adopt a lean process focusing on the risks that will derail the trial, allowing a select few the ability to focus on what is important; An example of this is the development and documentation of a risk assessment at the start of a trial, which needs to be initiated by the sponsor during protocol development rather than the Clinical Research Organization (CRO) (as so often occurs).

• The number of risks needs to be commensurate with the critical quality factors that can derail a trial. At the point when a CRO becomes involved in running the clinical trial, and risk assessment and tracking is handed over, the sponsor must still maintain some risks. Remember, using a CRO is a risk that should also be retained. Ensure you have a standard operating procedure in place that is lean, timely, and prioritizes the critical risks based on your assessment, outlines the control and mitigation steps for data-driven detected risks, and ensures appropriate issue management is practiced.

Strong Project & Vendor Management

Having a well-documented process for how outsourced services are overseen is critical for small biotech and pharma companies, considering their limited resources.

• Emphasis should be placed on the vendors providing key services, and oversight should be managed by the person departmentally aligned with the service (if that person exists).
• Vendor oversight should be documented in a plan which incorporates key performance indicators, escalation pathways, and governance structure. And, project management needs to be set up with clear governance and decision rights and have integrated project planning.
• An example is allowing a Clinical Trial Manager to make the decision for an site selection unless it involves a key opinion leader or country-level Private Investigator which should be discussed more broadly.

Lastly, I cannot discuss people and processes without touching on technology. Companies, regardless of size, should still invest in technology that is right-sized for their budget and strategic use cases. Start small – review what is operationally burdensome, build a case, and then, if approved, be critical whether that will be managed in-house or outsourced, and if outsourced, be intentional about your selection criteria. While technology is a tool to provide information and signals, it still requires governance – a human to oversee, interpret, and take appropriate action.

In this fast-paced environment, agility and innovation extend beyond scientific breakthroughs; they must also be embedded in the way organizations operate. By strategically linking people with processes, success can be found in this increasingly competitive landscape.

Curious to learn more? Join our upcoming webinar on March 19th that will dive deeper into this topic—reserve your seat today by clicking the link. 

Discover more of our clinical development and operations insights.