Clinical Investigation Set Up
Setting up a clinical investigation takes careful planning and the creation of clear, high-quality documents to ensure everything runs smoothly and meets all the necessary regulations.
This is a key step in making sure your investigation is designed to achieve its goals while following ethical and legal standards.
It is not just about meeting regulatory requirements; it is about building a solid foundation that supports efficient operations and protects participants. A well-planned investigational setup can help avoid delays, minimise risks, and ensure the study produces accurate, trustworthy results.
Key components of investigational setup:
Protocol Development: Creating a clear and concise study protocol that defines the objectives, design, methodology, and statistical considerations for your investigation. A well-structured protocol ensures consistency, transparency, and compliance throughout the study.
IRAS Submissions: Navigating the Integrated Research Application System (IRAS) to submit applications for ethical and regulatory approvals in the UK. We ensure accuracy and completeness at this stage to reduce delays and streamline the approval process.
NHS R&D Approvals: Providing support for the NHS approvals process, ensuring all required permissions are obtained efficiently to allow your investigation to proceed without unnecessary delays.
Trial Master File (TMF) Preparation: Ensuring your TMF is complete and audit-ready from the start. This includes not only standard trial documents but also patient-facing materials such as Patient Information Sheets (PIS) and Informed Consent Forms (ICF), designed to be clear and easy for participants to understand.
Good Clinical Practice (GCP) Training: Offering GCP training to ensure your team is fully equipped to conduct clinical investigations ethically and scientifically, in line with internationally recognised standards.
Advisory Support: Providing strategic guidance to address investigational design, operational considerations, and risk mitigation strategies tailored to your specific study needs. For organisations taking on the role of sponsor for the first time, we can provide tailored guidance on the legal responsibilities involved. This includes advice on regulatory submissions, oversight responsibilities, and meeting GCP standards, ensuring you are well-prepared for this critical role.
Best Practices
Align with internationally recognised standards
To ensure the highest level of compliance and quality, clinical investigations must adhere to international guidelines and frameworks specific to interventional studies. For example:
ICH E6 (R2): The International Council for Harmonisation (ICH) guideline on Good Clinical Practice (GCP), which sets global standards for designing, conducting, and reporting clinical trials.
ISO 14155:2020: Guidance on clinical investigations, particularly relevant for medical device trials.
NHS and MHRA Guidelines: Detailed requirements for ethical approval, study design, and regulatory compliance in the UK.
Safety and Adverse Event Reporting: Meeting standards for documenting and reporting participant safety concerns, such as the MHRA pharmacovigilance requirements.
Data Privacy Standards: Compliance with GDPR or equivalent regulations to protect participant information.
Adhering to these standards not only supports compliance but also strengthens the scientific and ethical foundation of your investigation, ensuring it is credible to regulators and stakeholders alike.
Case Study
How Hardian solves the problem.
Hardian has worked with multiple clients in developing and designing clinical studies that align aims across multiple verticals including regulatory submissions, health economic activities and market strategies.
A well-designed study that accounts for multiple stakeholders can save significant long-term costs, and Hardian’s multidisciplinary team is here to make sure that your studies are aligned with your product and long-term strategy.
Get in touch
Get in touch to see how Hardian can help you streamline your Clinical Investigations process.