Clinical Trial Plan & Conduct
Clinical Evaluation and Clinical trial conduct
Clinical evaluation is one of the elements required in the medical product development phase. It is to validate the safety and performance/efficacy of a medical product (medical device/drug) before it is mass produced for commercialisation. Depending on the product risk and country of registration, different clinical evaluation requirements is required for the regulatory product approval.
The clinical evaluation can be based on clinical evidence from these 3 sources:
· Literature search
· Post-market safety; and
· Clinical investigation (also known as clinical trial on humans).
ARQon clinical team will provide professional support beginning from phase I; research to market launch, and/or to medical indication expansion. With our product registration experience and presence in different countries including US, Europe, China and Japan (most popular countries for clinical trial), we can also help to liaise with the Authority on clinical evidence source requirements.
We can help to prepare:
· the Clinical Evaluation Plan and Report based on the relevant sources;
· the Clinical trial plan, protocol, site and its principal investigator search and management; and
· discussion with the company on clinical strategy, liasing with the Authority, submission and approval for clinical trial application.
For the Clinical evaluation plan and report, the requirement is becoming more stringent not just in US, China and Japan, but also in the new Europe Medical Device Regulation for CE marking.
For the Clinical trial, these are the general process and terms in which we will have to assess, if not all, a few of the terms are needed to gain regulatory approval:
· Phase I – first-in-man study (first human dose, PK/PD studies, bioavailability
· Phase II – proof-of-concept studies
· Phase III – safety and performance/efficacy studies
· Investigational Device Exemptions (IDE)
· DIMDI Submissions
· Performance evaluations
· Phase IV – post-market clinical follow up (PMCF) / medical indication expansion
For a standard clinical trial management, there will be a detailed consultation and planning by ARQon clinical team for the following:
· Preparation of all essential documents such as; Protocol, Informed Consent Form, Patient information;
· Site Feasibility check, including selection and recruiting of study sites;
· CRF design (electronically and/or paper based);
· IRB / Ethical Review Board proceedings: Support, preparation, conduct and follow-up of clinical trial submission to IRBs, local and national authorities; as well as the German Institute of Medical Documentation and Information in USA, Germany, and Colombia;
· Organization and conduct of investigator meetings or start-up visits;
· Project Controlling;
· CRA trainings (study-specific training of monitors);
· Drug, material and laboratory logistics;
· Supervision of Vendors;
· Development of study Database;
· Selection and organization of the randomization procedure (in collaboration with our quality management);
· GCP-compliant project documentation in the Trial Master File and the investigator site file(s);
· Monitoring Supervision;
· Site Management;
· Database close;
· Analysis / Statistics; and
· Reporting (to regulatory bodies)