Start-up Services / Regulatory Submissions

JDP clinical research project team collaborates closely with the project team choice of the sponsor to determine what the best strategies to starting the study are. After carefully assessing all applicable documents provided by the sponsor, JDP will develop a plan that will aid in the effective commencement of the study. JDP will help to develop or review the study protocol and case report forms to allow for a full understanding of the study design. JDP works with sponsors and investigators in preparing regulatory dossiers. 

Our staff have a very good understanding of the regulatory environment and what it takes to ensure expedited approval process in order to meet protocol timelines. We ensure adequate logistics and personnel are available for a study take off. JDP supports the development of the following study materials: case report forms (CRFs), source documents, study logs, patient binders, informed consent forms, the investigator brochure, the monitoring plan, the Trial Master File (TMF), and the monitor and site training materials. JDP will also work closely with the sites, guiding them through the study set up activities including essential document collection and GCP training. We facilitate the importation of study materials and investigational products. We again offer translation services.