Frequently Asked Questions

A fractional scientist is one that provides to you the expertise you need but without being brought in-house as a full-time employee.

This saves overhead, time in hiring, and ensures you don’t have a commitment in perpetuity.

For validation studies: While ActiVie can work collaboratively with academic institutions, our approach is generally more aligned with your business needs. Academic organizations typically focus on niche scientific capabilities and may prioritize publishing peer-reviewed articles, which can extend timelines. Additionally, academic labs often involve graduate students with competing priorities, potentially delaying your project. Furthermore, working with academic institutions can incur additional overhead costs due to external funding mechanisms. ActiVie, by contrast, is driven by your timeline and commercial goals, ensuring strategic alignment and efficiency in delivering results.

For clinical trials: ActiVie typically works with academic clinical trial sites. In these scenarios ActiVie usually plays a trial management role and works with sites to ensure all paperwork is up-to-date, data are collected appropriately, subjects are being enrolled as expected, payments are being sent and received as expected, and that trial integrity is maintained.

While typical, large CROs are highly skilled at operationalizing clinical research, ActiVie offers more than just operational support. Our team is composed of scientists and technical experts at every level, providing you with a strategic, science-driven approach. We focus on understanding the bigger picture, developing clinical or regulatory strategies, and optimizing your time and resources. We don’t just execute—we provide guidance to ensure your research questions are strategically aligned with your business goals.

We begin with an in-depth conversation to fully understand your needs and determine if there is a good fit. Once we've identified the right approach, we’ll provide a proposal with clear timelines and an itemized budget. This proposal outlines the scope of work, deliverables, and expectations, which we collaboratively refine with you to ensure it aligns with your goals. After finalizing the proposal, we formalize the partnership through a services agreement and statement of work.

We offer a wide range of clinical research support, tailored to your specific needs. For clients with well-defined research questions, we help prepare a comprehensive study document package for IRB or ethics committee submissions, including protocols, informed consent forms, and participant-facing documents. For clients with collected data, we provide in-depth analysis, reporting results, and offering insights and next steps. Additionally, for those running global clinical trials, we offer vendor management, SOP writing, system development, and more.

If a client is not quite ready for clinical trials, we offer alternative strategies to prepare them for success, ensuring that every step of the process is collaborative, transparent, and efficient.

ActiVie’s team of regulatory experts works closely with you to ensure your clinical trials adhere to all necessary national and international regulatory standards. From preparing documentation to managing submissions, we ensure that your research is conducted in compliance with the latest regulations, streamlining the approval process and mitigating potential risks.

ActiVie’s expertise spans clinical research, trial management, and regulatory submissions for a wide range of medical devices and some pharma products, including wearables, implantable devices, and diagnostics. We tailor our solutions to meet the specific needs of the medical device industry, ensuring precision and compliance at every stage of development. This includes in-depth research into a specific therapeutic area to ensure we have a solid understanding of trial norms and expectations.

We have deep expertise in cardiovascular technologies, spine implants, wearable technologies (e.g., sensor validation), and real-world evidence studies for pharma assets. Globally we’ve worked with more class III than class II devices but have worked with a range.

Once we’ve discussed your needs and finalized the proposal, we can begin work promptly, depending on the complexity of the project and current timelines. We pride ourselves on efficiency and aim to get your project underway as quickly as possible to meet your critical milestones. We’ve had full trial setups (including all systems) in 2 months!

Early-stage health tech startups, mid-sized enterprises, and investment groups looking to validate clinical outcomes and navigate regulatory challenges benefit most from ActiVie’s fractional support model. Whether you're seeking scientific expertise for a pilot study, regulatory guidance for market entry, or operational support for large-scale trials, ActiVie provides the flexible, high-quality expertise you need and grows with you.

Yes, ActiVie has extensive experience supporting global clinical trials. From managing complex regulatory requirements across multiple regions to handling vendor relationships and building tailored clinical trial systems, we ensure that your global trials run smoothly and efficiently.