R&d Frontiers

R&D Frontiers is a clinical research company with a specific focus on medical monitoring and clinical safety services provided to pharmaceutical and biotechnology organizations across a variety of therapeutic indications during I to phases of clinical development. Implementation of drug safety activities: • Safety profile monitoring during the conduct of Phase I, Phase IIa, Phase IIb and Phase clinical trials • Signal management and analysis of safety data • ICSR review and query generation • Literature review • Implementation of safety recommendations • Preparation of risk profile summaries for comparator compounds • DSUR review • Preparation of responses to requests made by regulatory authorities Implementation of medical monitoring activities: • Medical monitoring plan development and review • Guidance of the investigative sites and project team regarding protocol interpretation • Assessing and providing responses to requests related to eligibility of trial subjects • Providing responses to requests related to unblinding, concomitant medication and rescue medication • Medical review of protocol deviations • Ensuring that actions taken regarding the study treatment are appropriate • Acting as 24-hour urgent contact • Medical data review including verification of consistency of data, identification of unreported AEs, exclusionary co-morbidities, prohibited medications, etc. Contribution during medical writing process of the following documents: • Clinical Trial Protocols • ICFs • Investigator Brochures • Clinical Trial Reports Feasibility research: • Preparation of feasibility questionnaires, surveys and country feasibility reports • Implementation of feasibility process • Interaction with business development and project management departments • Ensuring timelines for providing reports are met Provision of trainings on: • ICH GCP • General considerations for clinical trials • Pharmacovigilance • Statistical principles for clinical trials