Fortifying The 3 Cs With Strategic Approaches And Tools

By Richard Malone, PharmD, MHA, Tanisha Patel, Vincent Puglia, and Renee Riggs

The solution to fortifying the foundation of business sourcing and partnering strategies lies in fostering an inclusive, communicative, and collaborative culture both internally and externally. This initiative begins with a concerted effort to improve the organizational culture toward stakeholder engagement, remove silos, and establish optimal communications.

In part one of this series, we focused on assessment. We described how a sponsor company can identify communication and expectation gaps between itself, its partners, and clinical trial sites. Specifically, we discussed an example using a pharmacy manual to illustrate how breakdowns in communication can cause problems.

Here, we’ll continue the discussion by identifying specific tools and strategies that companies can use to improve communication and collaboration.

Cultivating An Inclusive And Communicative Culture

To herald this cultural shift, leadership sponsorship is paramount. Leaders across the organization must champion a culture that values open communication, collaboration, and community. By doing so, they can begin to dismantle the barriers that hinder effective partner and provider integrations.

It is critically important for the cross-functional knowledge to be shared and to permeate the business processes, but it may be even more important that leadership takes an active position in ensuring that hierarchies and silence do not impede or obfuscate perspectives and discussions. In conducting interviews with employees globally¹, a common theme emerged regarding their reluctance to voice opinions and concerns. Regardless of location or industry, employees shared a universal apprehension about the potential consequences of speaking up. This widespread silence points toward a critical area for organizational development — creating an environment where employees feel safe and valued in sharing their insights and feedback.

Extending The Culture Beyond Organizational Boundaries

Just as crucial as cultivating this culture internally, extending these values to include partners and providers is essential for nurturing trust and inclusiveness. Indeed, cultural fit and mutually held values are widely recognized as strong indicators of success and are specifically recommended for consideration². Organizations can empower their partners to deliver the best services and achieve their highest potential. This approach fosters a sense of shared destiny, where the success of one directly contributes to the success of the other.

It should be recognized that in some paradigms there might not be provisioning for evaluation of culture, or it may be precluded for specific business or contractual reasons. In these situations, secondary indicators of culture may be identified and applied to the governance and maintenance of the relationship, if there is not an avenue for evaluation at inception.  Some examples of accessible secondary indicators include: 

• assessing interactions and market perception through feedback and reputation
• noting company events and traditions that can reveal the company's values and priorities
• observing exchanges, even minor interactions, and subsequently sharing to extract insights on communication styles
• considering fundamental business aspects, like whether the company's operational pace aligns with your organization's workflow

Leverage Quality By Design For Better Relationships

Quality by design (QbD) is a systematic approach that starts with clear goals, focuses on understanding outcomes and processes, and emphasizes process control through science and risk management. While QbD may not seem warm and fuzzy, it also plays a key role in improving business relationships. By embracing QbD principles, organizations commit to high-quality standards from the start, extending to outcomes, services, and relationship-building. This shared quality focus enhances partnerships, promoting trust and respect. Operating with aligned goals and clear expectations, QbD methods foster proactive quality practices for stronger, resilient partnerships. Prioritizing quality up front helps organizations build adaptive sourcing strategies that manage risks effectively.

Managing Silos

Managing silos within the organization is a critical step in fostering a culture of collaboration. By encouraging cross-functional team engagement and fluid information sharing, companies can leverage a diverse range of perspectives and skills, enriching the quality of decision-making processes, while ensuring the most impactful elements and needs of the collective are in focus. It also allows for a feedback loop with a deep reach to grow, enabling process improvement. 

Along with supporting an active process full of informed discourse, it also allows for a good defense of processes and protection of valued relationships. Asymmetries in information or lack of the empowerment of an individual to feel confident they are representing all the interests of their organization and colleagues creates imbalances that can be exploited, either unintentionally or intentionally. Processes circumvented by a team, contacts bypassing business owners, or outsourcing teams lacking evaluation means are just some examples of blocks that are sliding out of place and in need of a reset.

Fostering Trust Through Transparent Communication

A consultative approach to interactions—both internal and external—enhances the richness of communication. Creating environments where ideas are freely exchanged and feedback is actively encouraged strengthens relationships and builds trust. Such environments thrive on transparency, where decisions and processes are made visible and understandable to all involved parties.  Transparent communication can result in process improvement simply by creating an open environment in which stakeholders and partners will organically share inefficiencies or misalignment utilizing a collaborative lens instead of one of criticism.

The presence of data chaos and the absence of a shared workspace also contribute to a lack of clarity. Transparent communications need a reliable, daily conduit. Wherever feasible, integrate systems, data, and processes across functions and organizations, and leverage collaboration applications. Shared tools and platforms facilitate seamless information flow and cooperation, reducing barriers caused by disparate systems.

Tangible Activities And Tools For Improvement

Once discussions begin on organizational and partner dynamics, the drive to establish, improve, or enhance these areas emerges swiftly. However, this process can feel overwhelming, lacking clear starting points to make meaningful progress.

An actionable step everyone can take is simple: write it down.

One of the main destabilizing factors lies in undefined expectations, fostering confusion and discontent. To avoid these pitfalls, create an "expectations map" incorporating key elements:

• RACIs (Responsible, Accountable, Consulted, Informed matrices). These are simple but powerful tools that can be reliably applied and bolster confidence in communications and actions. It should never be viewed as a “stay in your lane” exercise, but more as a builder of pathways of trust.
• Service Descriptions Matrix. This serves as a comprehensive framework that outlines the services offered by an organization, detailing the responsibilities and expectations associated with each service. It acts as a bridge between the service provider and the recipient, ensuring clarity by meticulously defining what each service entails, who is responsible for delivering each aspect of the service (aligned with the RACI model), and the expected outcomes.
• Decision Logs. This is an essential tool that records all significant decisions made during a project or operational process, including the rationale behind each decision and its implications. This not only provides a historical record for reference but also ensures transparency and accountability within the team. It's a scalable and cost-effective resource because it requires minimal investment to maintain while offering significant benefits across diverse organizational sizes and types. By centralizing decision-making insights, it facilitates easier onboarding of new team members and supports informed future decision-making, thereby amplifying its utility without necessitating substantial resources.
• Task Ownership Guide. This is a document outlining roles and responsibilities in projects or ongoing services. It clarifies accountability, streamlines communication, enhances efficiency, and prevents task duplication or neglect. Assigning ownership ensures stakeholders understand their duties, fostering a cohesive work environment for achieving organizational goals.
• Business Continuity Plan. This document is instrumental in setting and maintaining expectations by outlining a clear, actionable strategy for navigating disruptions.
• KPIs. KPIs are measurable metrics reflecting an organization's success in meeting key objectives. Defined, shared, and written KPIs establish a clear, objective standard for assessing performance. This process aligns stakeholders and promotes accountability.

These versatile tools are applicable across all sectors, benefiting sponsors, providers, and clinical sites alike. In all cases, they are most effective when involving hands-on contributors in crafting these components.

Conclusion

The intricacy of today’s business environment demands more than just strategic acumen and operational efficiency. Lack of clear communication, direction, and flow can result in individuals or groups believing they are filling in the gaps, when they are in reality creating more spaces. This can be positively skewed if the person has rose tinted vision or negatively skewed. Both can impact the workforce, quality of work, output, and sense of belonging. Clearly defined organizational goals and a road map to achieve these and the expectations of individuals or departments can help the whole company pull in the same direction toward a common goal, fostering a feeling of purpose and team spirit.

At the heart of successful sourcing and partnering initiatives lies a robust organizational culture founded on principles of collaboration, communication, transparency, and open mindsets. By recognizing and addressing the potential pitfalls presented by poor communication and cultural alignment, businesses can not only secure their existing structures but also pave the way for sustainable growth and innovation.

In the grand game of business strategy, ensuring all pieces are aligned and supported creates not a precarious tower but a resilient and adaptable framework capable of withstanding challenges and seizing opportunities. The commitment to this continuous improvement process is what distinguishes leaders in the clinical trial landscape, inspiring a collective stride toward excellence, innovation, and mutual success.

References:

1. Building a Culture Where Employees Feel Free to Speak Up, Timothy R. Clark, HBR August 16, 2023. https://hbr.org/2023/08/building-a-culture-where-employees-feel-free-to-speak-up
2. Best Practices For Sourcing & Outsourcing In Clinical Operations, Krishnan Rajagopalan, Ph.D., Life Sciences Transformation Group, Clinical Leader, October 21, 2021. https://www.clinicalleader.com/doc/best-practices-for-sourcing-outsourcing-in-clinical-operations-0001

About The Authors:

Richard Malone, Pharm.D., MHA, serves as president at McCreadie Group. With over 30 years of combined experience in clinical research, pharmacy, and healthcare administration, Rick brings a wealth of knowledge and experience in investigational product management, site experience, and opportunities to leverage technology to reduce site burden in clinical trials. In his role, Rick oversees delivery of McCreadie’s software solutions with a focus on maximizing efficiency, compliance, and quality at client sites. Rick earned his Doctor of Pharmacy degree from the University of Tennessee Health Science Center and his master’s in healthcare administration from the University of Maryland.

Tanisha Patel is an experienced global clinical procurement professional in a large to mid-sized pharma/biotech. Tanisha specializes in supplier management and negotiations, process, system and relationship improvement and stabilization, training, strategy development and implementation, risk mitigation, category projects, team management, and mentoring. She is skilled at establishing strategic partnerships with internal stakeholders and suppliers/sponsors, including acquired or merger entities, with out-of-the-box thinking to elevate organizations as a sponsor/supplier of choice.

Vincent Puglia is a seasoned expert in clinical trial business and technology, currently working as a senior director in RTSM Strategy at Veeva Systems. With over 20 years of experience in regulated technical fields, Vincent has a deep understanding of both business and technology, contributes directly and collaboratively to transforming organizations, and excels at forging strategic relationships. In his current role, he is part of the leadership team at Veeva RTSM, focusing on building community, enhancing integrations, and creating strategic alliances for RTSM across clinical development, CMO, and logistics sectors. Vincent has previously held key positions at both the technology provider and sponsor organizations such as Regeneron and Moderna. He holds a Bachelor of Science from DeSales University.

Renee Riggs is currently a director of clinical processes and operations with Emergent BioSolutions. She has held positions in clinical research across biotech companies for over 27 years. Her passion is to play a role in enhancing team connections, influencing operational excellence, and overall improving the timeline to provide quality products to patients. 

Note: At the time of article development, Vincent Puglia was employed with a sponsor company.