Clinical Operations
Validating Your Vision, Accelerating Your Success
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
OUR INSIGHTS
At SSI Strategy, we believe that knowledge is a key driver in building better biotechs. Our Insights provide valuable information and expert perspectives to empower biotech leaders like you.
LET’S TALK
You don't have to go it alone!
Our experienced team has been there before, and we're ready to guide you through the unknown. Share your challenges with us, and together, we'll create a plan to efficiently reach your milestones and turn your vision into reality.
Building Better Biotechs
