How We Help You

Strategic clinical support every step of the way

ActiVie’s expert scientists offer tailored, end-to-end services to provide the strategic and operational support you need to bring your medical innovations to market quickly and efficiently.

Two people sitting at a table in an office, engaged in conversation, with a window in the background.

We consider ourselves fairly agnostic to therapeutic area but have deeper expertise in spine, cardiovascular, and wearable technologies. Read below about how we support you to achieve market access.

  • 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 and reporting, 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.

  • 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 are accurate and complete.

  • The path to market 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.

  • Data are 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Technical Skills

As a team of clinical research and operations generalists, we know you need a wide variety of skills to help bring your product to market quickly and efficiently.

  • Our team has extensive expertise designing human research studies. From minimal risk, observational studies to global significant risk studies, we can help you achieve your goals on time and on budget.

  • Managing study or trial operations can be complicated and not always something you want to take on in-house. Our team has managed studies from just a few people at one location to hundreds worldwide. We know how to streamline for study success without extraneous budget.

  • “Digital health” seems to be a hot term these days. What does that mean? Our team of experts have worked in digital health startups and navigated this space too. We understand the enormous potential of digital interventions or using decentralized clinical trials (DCTs). We can support in study design for best practices and guide your team on how to navigate the tech-pace within health research.

  • Many wearable device (think prosthetic leg, smartwatch) systems have effects on how people move and navigate their environment. With gold standard laboratory and real-world experience in biomechanics, we can support your product development, claims support, or other product testing with actual users!

  • Our team is trained and experienced with data and statistical analyses for all kinds of human-generated data. From EHR to motion capture to wearable sensor to user perception data, we can help you organize, analyze, and interpret your data.

  • We have written peer-reviewed papers, white papers, research protocols, recruitment materials, marketing materials, clinical reports, and internal operations documents. Our team is experienced in a diverse set of therapeutic areas and geographies.

  • Some of us are educators. Some of us have certifications in health education. We all know the value of meeting your client or customer where they are and can help educate your audience effectively.

  • The most important part of human research programs or clinical trials are the people. People who are sometimes called “subjects” or “patients” or “participants”. These people benefit from our expertise in developing study materials that optimize recruitment, understanding, and engagement throughout a study.

  • So you did a scientific study. Awesome. Now what? How do you take those insights and translate them for your customer or client? We leverage our startup generalist, educator, and patient engagement expertise to help you develop collateral that is accurate and impactful.

  • As scientists, we are sticklers for backing up our claims. We’ve supported various companies and industries (from sports equipment to medical device and pharmaceutical companies) to test their claims with their actual user base. We have also supported claims with literature reviews and references. Whatever you need, we can help.

  • The Voice of Customer (VOC) is incredibly important in product development; just like user testing and feedback in a laboratory setting can be. Our qualitative research experts can design, execute, and analyze your user data to understand your customer’s voice and inform product development.