Services
Documentation & Systems
Bringing your product to market requires having the right systems and documentation in place, fast. At ActiVie, we build clinical trial systems that are tailored to your needs—whether you’re implementing an Electronic Data Capture (EDC) system, a Clinical Trial Management System (CTMS), or an Electronic Trial Master File (eTMF). Our team delivers global study designs, regulatory submissions, and Standard Operating Procedures (SOPs) with speed and precision to streamline your clinical operations.
Beyond just providing the tools, we deliver precise user guides and resources that integrate seamlessly into your workflow, allowing you to maintain high operational standards without the burden of developing these systems in-house. Our approach ensures you have everything in place to run your trials smoothly, on time, and with full regulatory compliance.
Beyond just providing the tools, we deliver precise user guides and resources that integrate seamlessly into your workflow, allowing you to maintain high operational standards without the burden of developing these systems in-house. Our approach ensures you have everything in place to run your trials smoothly, on time, and with full regulatory compliance.
Clinical Trial Design & Operations
The path to clinical success starts with a solid trial design. ActiVie’s experienced team of scientists and researchers will work with you to create a detailed blueprint for your clinical trials, ensuring they are designed to meet both regulatory and clinical goals. Whether you're conducting a site-based or decentralized study, we help you navigate the complexities with expert operational support.
From patient recruitment to data management and trial execution, we ensure every phase of your trial is handled efficiently and accurately. Our flexible, fractional support model allows us to scale with you, whether you’re running a small pilot study or a large, multi-site trial.
From patient recruitment to data management and trial execution, we ensure every phase of your trial is handled efficiently and accurately. Our flexible, fractional support model allows us to scale with you, whether you’re running a small pilot study or a large, multi-site trial.
Global Regulatory Strategy & Submissions
Navigating the regulatory landscape can be one of the biggest hurdles for any health tech startup or enterprise. ActiVie’s regulatory experts provide strategic guidance that helps you stay ahead of ever-changing global compliance requirements. Whether you're preparing an Investigational Device Exemption (IDE) or a Premarket Approval (PMA) submission, we ensure your documentation is comprehensive, accurate, and aligned with the latest regulatory standards.
Our team doesn’t just help you with submissions; we partner with you through every step of the regulatory process, offering proactive insights and strategies to streamline approvals, mitigate risks, and accelerate your path to market.
Our team doesn’t just help you with submissions; we partner with you through every step of the regulatory process, offering proactive insights and strategies to streamline approvals, mitigate risks, and accelerate your path to market.
Scientific Publications
Turning your research into impactful scientific publications is crucial for establishing credibility and enhancing your brand in the medical field. ActiVie’s team of experts will assist you in crafting and editing clinical study reports, white papers, and journal articles that effectively communicate your findings.
Our goal is to help you translate complex data into compelling narratives that resonate with stakeholders, from regulators to investors and the broader scientific community. We ensure your research is presented with clarity and authority, positioning your company as a leader in your field.
Our goal is to help you translate complex data into compelling narratives that resonate with stakeholders, from regulators to investors and the broader scientific community. We ensure your research is presented with clarity and authority, positioning your company as a leader in your field.
Data Analysis & Reporting
Data is the foundation of every successful clinical trial. ActiVie’s scientists and statisticians provide in-depth data analysis that allows you to make informed, evidence-based decisions. We provide comprehensive reports on trial outcomes, safety data, and efficacy measures, ensuring you have the insights needed to make confident, data-driven decisions.
Our team specializes in translating raw data into actionable insights, providing you with clear, precise reports that help guide the direction of your product development. Whether you're navigating a critical decision point or preparing for a regulatory submission, we deliver the data you need to succeed.
Our team specializes in translating raw data into actionable insights, providing you with clear, precise reports that help guide the direction of your product development. Whether you're navigating a critical decision point or preparing for a regulatory submission, we deliver the data you need to succeed.
Postmarket Surveillance
Once your product has hit the market, you likely want and need to continue monitoring its safety and effectiveness via post-market surveillance. Or maybe you want to generate new marketing or label claims.
ActiVie's team of expert scientists and regulatory professionals can help you craft post-market surveillance studies, generate new data for marketing claims support, develop a label expansion strategy, or simply help with mandatory reporting. We learn first what your goals are as a business and translate those into actionable research.
ActiVie's team of expert scientists and regulatory professionals can help you craft post-market surveillance studies, generate new data for marketing claims support, develop a label expansion strategy, or simply help with mandatory reporting. We learn first what your goals are as a business and translate those into actionable research.
Biostatistics & Statistical Consulting
Turning data into actionable insights requires robust statistical planning and analysis. At ActiVie, we provide biostatistics and statistical consulting services that support every stage of your clinical trial. From sample size determination, power calculations, and statistical analysis plan (SAP) development, to interim and final analyses, we ensure your trial is designed to produce meaningful, reliable results.
Our expertise includes advanced modeling and custom statistical approaches that help you interpret complex datasets and make informed, data-driven decisions.
Our expertise includes advanced modeling and custom statistical approaches that help you interpret complex datasets and make informed, data-driven decisions.
Patient Recruitment & Retention Strategies
Successful clinical trials hinge on recruiting and retaining the right patient populations. ActiVie offers strategic patient recruitment and retention services tailored to your trial's specific needs. We help you identify and engage the ideal participants, implement strategies to maximize retention and maintain compliance throughout the study.
Our data-driven approach ensures that patient recruitment is efficient and cost-effective, while our retention strategies minimize dropout rates, allowing your trial to stay on track and within budget.
Our data-driven approach ensures that patient recruitment is efficient and cost-effective, while our retention strategies minimize dropout rates, allowing your trial to stay on track and within budget.
Site Management & Monitoring
Effective site management ensures that your trial runs smoothly and meets regulatory standards. ActiVie provides comprehensive site management and monitoring services, including site selection and initiation, training, and protocol adherence support, on-site and remote monitoring, and trial close-out assistance.
We ensure that each site is fully prepared, compliant, and equipped to meet the demands of your study, minimizing delays and ensuring data integrity across all trial locations.
We ensure that each site is fully prepared, compliant, and equipped to meet the demands of your study, minimizing delays and ensuring data integrity across all trial locations.
Clinical Data Management
Data integrity is critical to a successful clinical trial. At ActiVie, our clinical data management services cover everything from database setup, design, and management to data cleaning, validation, and Case Report Form (CRF) development. We handle query management and comprehensive data reviews to ensure your data is accurate and complete.
Our data management experts ensure your clinical trial data is meticulously handled, allowing you to focus on decision-making with confidence that your results are accurate and compliant with regulatory requirements.
Our data management experts ensure your clinical trial data is meticulously handled, allowing you to focus on decision-making with confidence that your results are accurate and compliant with regulatory requirements.
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Why Choose ActiVie?
Expert Support to Fast Track Your Clinical Success
At ActiVie, we provide tailored, flexible clinical expertise to help you navigate every phase of your product development journey. From clinical trial design to regulatory submissions and data analysis, we partner with you to accelerate timelines, reduce costs, and ensure your product meets the highest standards of efficacy and compliance.
Testimonials
Client Success Stories
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Maria Flynn
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Jennifer Smith
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Jane Brown
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Becky Linch
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Daniel Craig
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I would recommend practitioners at this center to everyone! They are great to work with and are excellemt trainers. Thank you all!
Mariam Ness
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