Clinical Operation Services
Study-Start up
We manage every step of the start-up phase—feasibility, ethics submissions, site preparation, and training—so your study begins smoothly and confidently.
1
Regulatory & Ethics Approvals
Navigating the regulatory landscape is critical to the success of any clinical trial. At Nexus Pharma Group, we offer expert guidance and hands-on support to ensure your study meets all ethical and governance requirements
We provide comprehensive and continuous support throughout the study lifecycle, preparing and submitting ethics and governance applications to HREC & RGO. We ensure submissions and protocol amendments are accurate and aligned with institutional and regulatory requirements.
Our team ensures all clinical trial activities adhere to regulatory standards, Good Clinical Practice (GCP), and sponsor requirements through rigorous monitoring and quality checks.
We facilitate seamless communication between sponsors, sites, ethics committees, and regulatory bodies to ensure smooth study progression.
We develop, review, and validate informed consent documents ensuring they meet ethical standards and regulatory compliance.
2
Site Preparation & Initiation
A successful clinical trial begins with well-prepared and fully engaged research sites. At Nexus Pharma Group, we provide comprehensive site start-up services that ensure each location is equipped, compliant, and ready to recruit from day one.
Site Feasibility & Qualification
Conduct detailed feasibility assessments and qualification visits to evaluate site capabilities, patient population access, infrastructure, and investigator experience. We help sponsors select high-performing sites that align with protocol requirements and enrolment goals.
Protocol & SOP Training
Deliver comprehensive training sessions for investigators, study coordinators, and site staff covering protocol-specific procedures, standard operating procedures (SOPs), safety reporting, and Good Clinical Practice (GCP) requirements. Training is customized to each site’s role and responsibilities.
Trial Master File (TMF) Maintenance
Maintain a compliant Trial Master File (TMF) and Investigator Site File (ISF), ensuring all essential documents are accurately filed, version-controlled, and inspection-ready throughout the trial lifecycle.
Ongoing Support & Refresher Training
Provide continuous training and support throughout the study, including protocol amendments, safety updates, and audit preparation. We ensure site teams remain confident, compliant, and engaged.
Site Initiation Visits (SIVs) & Start-Up Coordination
Plan and execute Site Initiation Visits and start-up meetings to ensure site teams are trained, equipped, and aligned with study expectations. We cover protocol training, safety reporting, EDC access, and regulatory documentation to streamline activation.