Clinical Trial Services

At GADx, we pride ourselves on delivering high quality Clinical Trial Services tailored specifically for medical devices. With expertise spanning both national and international markets, we are dedicated to supporting clinical trials at every step of the way.

What Sets Us Apart

Clinical trials for medical devices require precision, innovation, and a deep understanding of regulatory landscapes. Our clinical trials team can support and run evaluations at any stage of device development from proof-of-concept to stringent regulatory authority-compliant trials to support market authorisation.

We combine these elements to provide:

  • Comprehensive Trial Management: From protocol development to study execution, we ensure every aspect of the trial is handled with meticulous care.
  • Global Reach: Whether it's a local study or spans multiple countries, our team is equipped to navigate the complexities of diverse regulatory requirements and cultural considerations particularly in the USA and Africa.
  • Regulatory Expertise: We specialise in ensuring the device meets the stringent requirements of governing bodies, facilitating a smoother path to market approval.
  • Customised Solutions: Every device is unique, and so are its clinical trial needs. GADx offers tailored strategies to align with your specific goals and challenges.
Devanshi Pandit Clinical Affairs Manager

Our Services

We provide a full suite of services to support the medical device clinical trial, including:

  • Sourcing of biobank samples
  • Support with study design and protocol development
  • Site feasibility and site selection inclusive of vendor selection
  • Site set-up and trial management from start to end in line with ICH GCP & ISO 20916
  • Design data collection forms, known as Case Report Forms
  • Electronic Trial Master File and Investigator Site File documentation & management
  • Site initiation & training
  • Data management and biostatistics
  • Support with regulatory submissions and compliance
  • Generation of Standard Operating Procedures (SOPs)
  • Monitoring and quality assurance
  • Support with post-market surveillance and reporting
  • Assisting and preparing for site audits based on the requirements

Why chose GADx?

Partnering with GADx means collaborating with a team of professionals who are passionate about advancing medical technology. 

Our commitment to excellence, attention to detail, and global expertise makes us the ideal partner for your clinical research needs.

Whether you are developing a groundbreaking device or enhancing existing technologies, GADx is here to help bring your innovation to life.

Check out a recent project here.

Devanshi Pandit and Josie Mensah-Kane at the HOLICARE Annual Conference and Diagnostics Workshop

Get In Touch

Contact GADx today to learn how our services can support your clinical trial journey. Together, we can pave the way for better healthcare solutions worldwide.

UK: +44 (0) 1234 780020 
USA: +1 (888) 381-6870 

Frequent testing is invaluable and so it is vital to find ways to drive down the cost of kits and increase production levels. As a social enterprise, GADx can transform this process because it ‘breaks the link’ of ‘having to make profit for shareholders’.

Paul Davis
Co-founder of Mologic and pioneer of lateral flow diagnostics.