{"id":7746,"date":"2021-11-12T11:09:33","date_gmt":"2021-11-12T09:09:33","guid":{"rendered":"https:\/\/medfilesgroup.com\/our-services\/pharmacovigilance-vigilance-service%e2%80%8b\/clinical-trials-safety\/"},"modified":"2026-09-09T08:23:34","modified_gmt":"2026-09-09T05:23:34","slug":"clinical-trials-safety","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/ja\/our-services\/pharmacovigilance-vigilance-service\/clinical-trials-safety\/","title":{"rendered":"Clinical Trials Safety"},"content":{"rendered":"\n
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Clinical Trial Safety services<\/h1>\n\n\n\n

Safety review and preparation of clinical trial documents<\/h2>\n\n\n\n

The requirements for clinical trials call for several safety-related documents. Medfiles\u2019 safety experts can help you with trial planning and preparation by providing comments and consultation on your protocol, data management plan, case report forms and study report. Close collaboration between safety, clinical and data management teams from the beginning of study planning is essential to ensure that safety data is collected appropriately in your trial.<\/p>\n\n\n\n

Medfiles also offers trial-specific adverse event training, with the applicable training materials, for study sites for investigator meetings and site initiation visits.<\/p>\n\n\n\n

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Safety management plans<\/h2>\n\n\n\n

When conducting clinical trials, the safety management plan (SMP) is one of the key documents that regulates all safety communication during the trial. The SMP details the roles, responsibilities, processes and timelines for the safety activities, ensures a systematic approach to safety monitoring and promotes early issue detection to help mitigate any safety risks for the clinical trial subjects.<\/p>\n\n\n\n

Medfiles\u2019 clinical safety experts provide consultation on the best way to set up safety management in your trial, taking into account the study phase, indication, trial subjects and other parties involved. We will prepare and review your safety management plan, with all associated forms, including your processes for reporting serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs).<\/p>\n\n\n\n

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Processing and submission of Serious Adverse Events (SAEs and SUSARs)<\/h2>\n\n\n\n

Medfiles\u2019 safety experts have plenty of experience in processing serious adverse event reports received from study investigators. Our experienced team will conduct triage of case reports to determine seriousness and causality of the event, enter the data into our pharmacovigilance database, code the medical information according to standardised MedDRA terminology and provide the case narrative, as well as follow up on the received reports and perform ongoing surveillance of case reports.<\/p>\n\n\n\n

Medfiles\u2019 safety physicians assess reported SAEs and SUSARs, including review of MedDRA coded terms, narratives and determination and documentation of the sponsor\u2019s causality assessments. This can be done independently from your operations or in close collaboration with your in-house safety physician or medical monitor.<\/p>\n\n\n\n

Our safety experts prepare expedited safety reports, including cover letters, electronic submissions and local submission of SUSARs to competent authorities, ethics committees and investigators, as per relevant regulatory reporting requirements.<\/p>\n\n\n\n

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Development safety update reports<\/h2>\n\n\n\n

If you need help with monitoring the safety profile of your investigational medicinal product, Medfiles\u2019 experts are happy to help. Development safety update reports (DSURs) provide a comprehensive overview of your investigational medicinal product\u2019s benefit-risk evaluation and ensure compliance with the applicable regulations. Medfiles\u2019 safety experts can write and submit DSURs during the developmental phase of your product.<\/p>\n\n\n\n

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Safety Database<\/h2>\n\n\n\n

Our validated cloud-based safety database PV 24\/7 is at your service round the clock. With the Medfiles Pharmacovigilance Data Management Team, you can process and submit your adverse event reports cost-effectively. We can collect the data from one study or from all your studies through an integrated global database for cumulative safety analyses.<\/p>\n\n\n\n

Benefits of the PV 24\/7 safety database<\/strong><\/p>\n\n\n\n