Clinical Operations

Validating Your Vision, Accelerating Your Success

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Enabling Key Clinical Milestones

Moving out of the lab and into the clinic is one of the most pivotal and costly inflection points in product development. It is critical to think holistically from Phase I through market authorization, building efficiency throughout your program.

Understanding both the strategic and operational aspects of clinical trial design and execution can mean the difference between a failed program and one that transforms the practice of medicine.

We can help you advance through your clinical program in a logical, stepwise manner that stays on track and within budget!

Organizational Build and Insourced Support

The quality of your clinical operations team can make or break your study. We help you design and establish a strategic, fit-for-purpose clinical operations organization that will scale with your study or business needs. Our team maps key roles, determines whether to hire, in-source, or outsource through a CRO/vendor, and assists in selecting and on-boarding the right vendors for your specific study needs.

Additionally, we can serve as an extension of your organization, providing Clinical Operations leadership, study execution support, vendor procurement and management, and data management. To further elevate your study, we support special strategic projects such as integrated clinical tech selection (e.g., wearables, eCOA) and novel endpoint development. Whether you need organizational design or direct operational support, our experienced team is equipped to enhance your clinical operations at every level.

Governance and Oversight Excellence

Effective governance and oversight are the cornerstones of successful clinical trial execution. Our experts work hand-in-hand with your team to design and implement a robust governance framework that provides clear lines of accountability, facilitates informed decision-making, and enables proactive risk management. We establish regular review cycles, implement best-practice processes and tools, and provide ongoing guidance and support to ensure that your trials are executed with the highest standards of quality and compliance. 

By instilling a culture of governance excellence, we empower your team to maintain control over your trials, anticipate and mitigate risks, and drive continuous improvement throughout the study lifecycle. 

Flexible, Scalable Support

We recognize that your clinical operations needs evolve as your trials progress from start-up to close-out. Our flexible, scalable support model allows us to adapt to your changing requirements, providing the expertise and resources you need at each stage of the trial lifecycle. Whether you require strategic guidance during protocol development, hands-on support for site selection and activation, or assistance with data management and analysis, our team is here to provide the skills and experience you need to succeed. 

This agile approach ensures that you have access to top-tier clinical operations support without the burden of maintaining a large internal infrastructure, optimizing your resource allocation and accelerating your timeline. 

Remediate or Rescue

We know firsthand that sometimes, despite your best efforts, your study may face challenges. If you are struggling to enroll, missing timelines, or experiencing significant change orders with your CRO, your study may be at risk. We're here to help. We conduct a holistic assessment to understand those risks and their root causes and develop a plan to remediate. We will support you in establishing enhanced governance, oversight, resource supplementation, and vendor replacement if necessary.  

With our extensive experience in navigating complex challenges, you can trust that your trials will get back on track and achieve their objectives. 

Why Partner with Us?

When you choose SSI Strategy as your clinical operations partner, you gain a trusted ally with a proven track record of delivering operational excellence and strategic leadership. Our unique combination of deep domain expertise, cross-functional collaboration, and flexible support model sets us apart and enables us to provide personalized solutions that address your specific challenges and goals.

We take pride in our ability to think strategically, anticipate risks, and drive execution excellence, helping you maintain control over your trials, optimize vendor performance, and bring your innovative therapies to patients faster and with greater success

SERVICE LEADERSHIP

Kate Goldstein

SVP Business Consulting

Kate Goldstein

SVP Business Consulting

Kate is passionate about applying innovative approaches to address the most complex challenges in life sciences. Since joining SSI in 2011, she has partnered with biotech leaders to build and scale their organizations, with a particular focus on strategies that accelerate or de-risk critical milestones. Her work is anchored in a singular priority: creating meaningful value—for client organizations, for investors, and ultimately for patients. In addition to her client work, Kate also drives several components of SSI’s own value creation strategy. She oversees the development and growth of SSI’s functional service offerings and leads the firm’s inorganic growth and M&A efforts.

Prior to SSI, Kate was part of Deloitte’s Strategy & Operations practice, where she delivered M&A integration, financial management, and human capital solutions. 

Key areas of expertise

  • Biotech growth strategy and milestone acceleration
  • Value creation through organizational design and scaling
  • M&A strategy, integration, and inorganic growth
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Heather Paden

VP Medical

Heather Paden

VP Medical

Heather Paden is a senior life sciences executive with thirty years in healthcare and more than two decades in the pharmaceutical industry. Heather specializes in aligning complex, global clinical trial operations execution with business objectives. She has led cross-functional teams through dozens of Phase I–IV studies, multiple product launches, and operational transformations, ensuring regulatory compliance and strategic alignment across stakeholders. Heather’s expertise spans respiratory, cardiovascular, oncology, and rare diseases (including pioneering gene therapy studies), with a track record of delivering large-scale trials on time and within budget. She is recognized for building agile high-performing teams and optimizing operational infrastructure to advance innovative therapies from development to market. 

Key areas of expertise

• Global clinical trial leadership and execution 
• Regulatory compliance and quality oversight 
• Cross-functional program and portfolio management 

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Brendan Slagle

Senior Director

Brendan Slagle

Senior Director

Brendan Slagle is a seasoned clinical research leader with over 18 years of experience driving global clinical evidence strategies across pharmaceuticals and , medical devices. He has successfully guided early-stage life science companies in bringing first products to market and supported large organizations in meeting evolving regulatory requirements, including EU MDR remediation activities. Brendan is recognized for rescuing underperforming clinical studies, optimizing operations, and aligning cross-functional teams to achieve compliance and commercial objectives. His expertise in rare and complex diseases and strategic KOL engagement positions him to deliver high-impact outcomes for complex, multi-stakeholder clinical programs. Brendan is passionate about bridging the gap between clinical development and clinical operations to ensure complex study endpoints and evidence needs can be achieved at scale across a variety of sites and regions. 

Key areas of expertise

  • Global clinical evidence generation strategies 
  • Novel endpoint design and implementation 
  • Regulatory compliance and operational optimization 
  • Clinical study rescue and risk mitigation 
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