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     Our Fields of Expertise

         
These include:-

     Regulatory Affairs Strategy

          * Scientific and medical project strategy and accountability for designing the clinical studies to meet
            guidelines, requirements and objectives
          * Study-Start-Up (SSU) activities - ethical (EC) and regulatory (CA) submissions
          * Organization of Meetings and Contacts with European Regulatory Authorities
          * Review and finalization of essential documents required for site initiation, including study protocol
          * Provide medical and scientific input to core documents for the project (e.g., target product profile (TPP), protocols, submissions)

     Clinical Development conforming to European Guidelines

          * Investigator site contracts, identification of other local regulatory requirements
          * adequacy of the programs scientific basis and obtain endorsement on the assumptions related to
            medical needs and clinical utility represented in the project development strategy

     Clinical Research in European sites

          * Contacts to European Opinion Leaders, "state of the art" input for project and protocol concept.
          * Finding suitable investigational sites and investigators selection
          * Study feasibility,
          * Handling all study materials and/or drug issues
          * Project management
          * Monitoring
          * Phase II and early phase III studies
          * Coordination of collection, quality checks, data entry, coding of clinical data
          * Evaluation of Clinical Studies, preparation and presentation of reports
          * Preparation of expert reports, publications, posters and presentations
          * Training of clinical research personnel, also "on-site"

cubes     Medical Monitoring

     * identify key opinion leader/principle investigator for the program to ensure input to team liaisons and
       coordination, supervising adherence to SOPs, preparation to quality assurance audits.
     * Ensuring local activities are undertaken in accordance with agreed timelines, allocated budgets, and required
       quality standards.
     * GCP quality assurance audits
     * Medical lead of the project team.
     * Act as scientific and medical liaison between internal teams and external groups such as investigators,
       regulatory authorities, etc.
     * Serve as the physician to physician contact for an Investigator site and provide medical expertise for
       answering questions and resolving study related issues


     Pharmacovigilance


     * Services related to pharmacovigilance and drug safety, including a medical "qualified person" expertise.
     * Safety reviews, AE reviews and assistance to staff with medical issues/questions and local regulatory interaction and safety questions from the site
       or local IRB/IEC

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