Assessing The 3Cs: Does Your Organization Have The Foundation For Clinical Trial Success?

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

Sourcing and partnering strategies play a pivotal role in defining a sponsor company’s effectiveness, efficiency, and ultimately, its success. Sites, providers, and sponsors operate in an increasingly complex environment, requiring dynamic, resilient, and agile business models to navigate the rapid pace of change. Often-overlooked foundational elements that bolster the strength and adaptability of these models are the organizational culture and communication frameworks.

Failure to address these cultural and communication deficiencies effectively is akin to playing a risky game of Jenga. With each missed opportunity for improvement, the structure becomes increasingly unstable, risking eventual collapse under the pressure of competition or the rapid pace of market changes. Organizations that fail to prioritize building and nurturing their relational and operational frameworks are at higher risk of facing negative consequences from instability. This can lead to increased risks for clinical trial participants and operations, missed opportunities, wasted resources, reduced engagement from partners and employees, and an inability to adapt to a changing landscape. It also hinders partnering opportunities for growth and innovation, positioning market leaders as drivers of industry advancement. Furthermore, it poses reputational risks for the organization and its suppliers.

In part one of this series on exploring the importance of culture, communication, and collaboration in clinical trial success, we discuss the makings of a strong company foundation and offer an assessment plan meant to reveal strengths and weaknesses in those three areas.

The Foundation

Fundamentally, the core principle of success is built upon a robust collaborative organizational culture, internally and/or with the ability to extend the culture outside the organization.

Deficiencies in this construct can severely destabilize business relationships and processes, consequently diluting the potential output and value of these partnerships. The challenge is rooted in how internal culture perceives and engages with stakeholders or subject matter experts In many instances, organizational resistance to change, entrenched hierarchies, political maneuvering, and a predisposition toward operational silos create formidable barriers to effective collaboration. Additionally, competitive pressures over resources, coupled with a reluctance to cross over therapeutic or functional boundaries, further exacerbate this predicament.

Externally, and between organizations, the lack of true partnering behaviors toward providers creating an ”us versus them” environment can lead to a blame culture, minimum expenditure for minimum gain, reprioritization of the account, imbalance of leverage, missed opportunities, and, ultimately, lack of collaboration, interest, and investment.

Assessing For Empty Spaces

Businesses often assume the “this is the way we’ve always done it” mentality equates to stability, while it may be hiding early warning signs of organizational ailment and impending collapse. Symptoms often manifest as:

• disjointed communication channels leading to lost information or misinterpretations
• partner and provider relationships characterized by transactional interactions rather than strategic, with mutual growth and understanding
• innovation stagnation due to fear of venturing beyond comfortable operational silos and processes
• an overarching culture of exclusion that stifles new ideas and discourages full engagement from all stakeholders
• fear of speaking up or potential “quiet quitting,” resulting in a narrow thought process or herd culture, thus stifling improvement, “out of the box,” and innovative thinking
• lack of clarity regarding expectations or the criteria for success or constantly “moving the mark” without reason, both internally and externally

Let's take a high-level sample of one clinical trial resource that touches multiple domains: the pharmacy manual. Pharmacy manuals serve as comprehensive guides to ensure standardized handling, storage, and administration of investigational medicinal products (IMPs) at all trial sites. These manuals offer detailed instructions on protocols such as receipt, inventory management, dispensation, and return or disposal of IMPs. They guarantee adherence to regulatory requirements and good clinical practice (GCP). Before the trial begins, these manuals are given to pharmacy staff and investigators at each site, and the process begins way upstream with the oversight of the sponsor.

Creating and maintaining the pharmacy manual is a significant undertaking for the sponsor, requiring input from multiple disciplines. The pharmacy manual also is a resource that may guide implementations in clinical trial systems for transactions or data capture. At each stage along the way, if the inputs and outputs become out of alignment and gaps develop or if new data must be integrated into a revision, this can have cascading effects across timelines, deliverables, and trial activities.

The successful development, management, and dissemination of the pharmacy manual carries significant weight, and already at this stage there is a complex, high-pressure environment to navigate.  From here we then add more variables from the site vector, with sites having differing levels of resources. Not knowing what questions to ask at the site qualification visit (SQV) might lead to receipt of a pharmacy manual at the site initiation visit (SIV) with compounding/dispensing instructions for which the site has no expertise nor proper equipment.

At every step in the process, any breakdown in the ability to ask questions, obtain information, confer on operational abilities, or integrate feedback into the process can create negative experiences for trial participants, sites, providers, CROs, and sponsors. None of these gaps or risks is unique to one group or company, but every part of the collective structure is vulnerable.

Assessment Exercise: Roles And Expectations

One assessment tool that can give insight into the communication and expectation gaps in your collective is a roles assessment exercise. The roles assessment can identify the gap between expectations and actual conditions. The outputs can be extended to clarify roles and expectations among stakeholders, ensuring transparency, efficiency, and collaboration in organizational settings. Here are the essential steps of the assessment:

• Prep: This initial phase involves identifying the stakeholders who will participate in the process, scheduling meetings or workshops as necessary and preparing materials, such as guidelines and templates, for the assessment.
• Initial Role Definition: At this stage, participants fill out templates to define their current roles and share their perceptions of their responsibilities. This step sets the foundation for a mutual understanding of roles as perceived by each stakeholder.
• Reality Check: This crucial phase presents an opportunity for stakeholders to present their actual roles versus the initial definitions and discuss any discrepancies.

This forms the basis of the assessment. If the group finds that expectations and actual conditions are closely aligned, only small adjustments might be needed. If there is a large gap, it's a time for openness and constructive dialogue to align perceptions with reality.

Additional steps can be applied for improvement:

• Refinement: Based on discussions in the previous step, roles are adjusted and refined to address any identified discrepancies. These adjustments are thoroughly documented to ensure clarity and serve as a reference.
• Implementation: The updated roles and expectations are shared with all relevant stakeholders. This phase includes training and support to facilitate the transition to the clarified roles and ensure everyone is on the same page.
• Follow-up: The final step establishes a continuous feedback loop through reviews and assessments to monitor how the implemented roles are functioning within the organization. This ongoing evaluation process fosters an environment of continuous improvement.

Partner Assessment Tools

Some tools that can help guide organizations in developing a partnering style and governance are supplier relationship analysis, such as supplier preferencing. Porter's Five Forces, value levers, SWOT, and PESTLE help assess the value of your business to providers; the space you and your providers operate in; the industry landscape and impacting factors; strengths, weaknesses, opportunities, and threats within your partnership; and political, environmental, socioeconomic, legal, and technology impacts on the industry’s players.

Here is a look at what these types of tools are and how they are typically leveraged.

Porter's Five Forces: This tool helps businesses understand the competition in their market. It looks at five important areas: how tough the competition is, how easy it is for new companies to start, how easy it is for customers to find other products, how much power customers have to set prices, and how much power suppliers have to set prices.

Value Levers: Value levers are strategies or actions a company can take to perform better and increase its value. These can include making operations more efficient, cutting costs, or finding ways to make more money.

SWOT Analysis: SWOT stands for Strengths, Weaknesses, Opportunities, and Threats. This tool helps a business figure out what it does well, where it can improve, what opportunities it has, and what challenges it might face.

PESTLE Analysis: This tool helps businesses understand bigger, outside factors that could affect them. It looks at Political, Economic, Social, Technological, Legal, and Environmental factors to help businesses plan better and be more prepared for the future.

These analyses enable companies to understand the market space in which they operate and their position (i.e. big player, influencer, easy or difficult to work with), what the strengths weaknesses threats, and opportunities are to their industry as a whole, to their business, to their suppliers and suppliers' suppliers and the impacts to these interconnected relationships. The combination of this information, if conducted realistically (without rose-tinted lenses), can add focus to company goals, roadmaps, and strategies by helping companies understand their reputation 'where they sit', the opportunities available for growth and innovation, what their leverage is and how changes in the industry/supplier landscape may influence their operations and how external challenges such as political tensions, the impact of economics (such as inflation and tax and cost of business/living), social changes (such as lifestyle or culture and availability of workforce in the aging population), technological advances and AI or lack of true Innovation in some industries, legal (local, regional and global laws i.e. data privacy differences globally), environmental (policies, climate change and social and legal views of climate footprints).

In part two of this series, discover several strategies for improving a company’s culture, communication, and approach to collaboration.

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.