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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE LIVE WEBINAR
February 11, 2025 | 9-10:30 AM EST

Expanding Horizons: Searching for the Ideal Early Feasibility Study (EFS) Location

Join us for this insightful webinar focused on the strategic planning and execution of Early Feasibility Studies (EFS)—a critical step in advancing innovative medical technologies. Conducting an EFS is more than a regulatory requirement; it’s a global business opportunity that paves the way for scaling your device to market faster and reducing risks along the journey. Whether you're an early-stage company or scaling your innovation, this webinar will guide you in making informed decisions that align with your goals.

We’ll explore why starting early is essential for a successful feasibility study and how a well-conducted EFS can set you up for the next stage of development. You’ll learn why engaging regulators, like the FDA and other global authorities, early in the process can streamline your path to approval. Plus, we’ll dive into the pros and cons of conducting EFS in major regions like the US and EU, along with key considerations for selecting ideal locations globally—including opportunities outside traditional markets.

Specifically, this webinar will help you:
  • Understand why EFS is a global business opportunity and how to leverage it effectively.
  • Learn how early planning and engagement with regulators can streamline your feasibility study.
  • Explore the advantages and challenges of major EFS locations, including the US and EU.
  • Identify important factors for choosing the best location for your EFS.
  • Discover attractive O-US/O-EU locations and how their data can support regulatory approval.
  • Gain insights into advancing your technology faster to deliver novel solutions to patients.

Register for the webinar
Expanding Horizons Searching for the Ideal Early Feasibility Study (EFS) Location-1
Who should attend?
  • Clinical Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
Register Now  

Hosted by

Vernon-Baker
Moderator:
Vernon Baker

Sr. Medical Device Guru,
Greenlight Guru
Anna Nikitina
Speaker:
ANNA NIKITINA

Head of Business Development and Legal
Clinical Accelerator

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About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

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About Clinical Accelerator

At Clinical Accelerator, we specialize in conducting clinical investigations of innovative medical devices across all major therapeutic areas, with a particular focus on the cardiovascular field. Our goal is to accelerate clinical development programs of international medical technology companies by facilitating early entry into the clinic and ensuring fast and efficient implementation of First-in-Human (FIH) and Early Feasibility Studies (EFS). Additionally, we are actively involved in late-stage pivotal studies. Clinical Accelerator offers cost-effective budgets, compact timelines for clinical development and a commitment to bringing much-needed innovative medical devices to the market fast.

Our studies take place in Central and Eastern Europe (CEE) and Central Asia, in countries like Georgia, Lithuania, Uzbekistan, and Poland, known for favorable regulatory environments and short start-up timelines. We collaborate with highly competent investigators and top research sites, including FDA-inspected facilities. 

We offer our medical device sponsors a broad range of clinical trial services, including study feasibility assessments, regulatory and ethics submissions, site selection and monitoring, study coordination and site management, safety reporting, data management and biostatistics, quality assurance and study logistics.

We deploy dedicated feasibility and patient enrollment support specialists who are focused on achieving enrollment targets within fixed, short timelines. In select locations we offer specialized Site Management Organization (SMO) services using our own professional site coordinators.

Clinical Accelerator is an academically linked clinical CRO. We were born in academia and are proud to work in close collaboration with many leading international thought leaders in the cardiovascular and other major therapeutic fields.

Visit their website to learn more.

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