Clinical studies have become increasingly complex, with larger scopes and longer timelines
While clinical pharmacology studies are crucial to demonstrate the safety and efficacy of your drug, they’ve grown particularly complex—with larger scopes, longer timelines, and an increased burden to execute.
Certara’s Clinical Pharmacology Study Execution team serves as an extension of your team, dedicated to address your unique program and regulatory needs. Whether you need additional resources for a specific team, or a full-service solution to facilitate your Phase 1 clinical pharmacology studies, we’ll make sure you have the tools and expertise to succeed.
Harness Certara’s deep expertise in study design, oversight, and analysis to optimize your drug’s clinical success
Comprised of accomplished clinical pharmacologists, biostatisticians, programmers, medical writers, clinical operations experts, and project managers, our integrated team will support the design, oversight, and execution of your clinical studies to accelerate clinical success.
Our team of functional experts will act as a fully integrated extension of your team, providing:
- Clinical Study Planning & Design
- Clinical Operations Support (Startup, Conduct & Closeout)
- Data Management Solutions & Support
- Compliant Clinical Study Outputs
Our unique ‘one team’ approach enables unbiased, evidence-based recommendations that will always have your best interest at heart. That means you’ll be able to operate more efficient and effective clinical studies, while reducing unnecessary costs.
Inform better decisions, faster
Acting as an extension of your team, we’re here to support your clinical study every step of the way.
From study design and startup through the Clinical Study Report and beyond, our integrated team of functional experts are equipped with the experience and resources to advance your clinical study forward.
Optimize your trial design
Our team of experts will partner with you directly to maximize clinical efficiencies without sacrificing quality.
By optimizing trial design and clinical strategy, our experts can help reduce the size of your study, decrease the number of trials needed, and shorten study durations to help save you time and money.
Streamline clinical operations
From study startup through the Clinical Study Report, we’re here to support your Phase 1 clinical study every step of the way. Our experts will write study-specific plans and manuals, help you achieve and maintain Part 11 compliance, and create an inspection-ready electronic Trial Master File (eTMF)—all while providing the day-to-day operational support needed to advance your clinical trial to completion.
Accelerate your path to approval
Your drug’s regulatory success hinges on your clinical study outputs. That’s why our team of dedicated experts will provide the submission ready CDISC datasets and outputs needed for your regulatory filing.
What’s more, our team of medical writing experts can also support the writing and publishing of your Clinical Study Report.
