Clinical trial safety service

Clinical Trial Safety services

Safety review and preparation of clinical trial documents

The requirements for clinical trials call for several safety-related documents. Medfiles’ 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.

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

Safety management plans

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.

Medfiles’ 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).

Processing and submission of Serious Adverse Events (SAEs and SUSARs)

Medfiles’ 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.

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

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.

Development safety update reports

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

Safety Database

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.

Benefits of the PV 24/7 safety database

  • Continuously up to date with the latest regulatory requirements
  • Direct gateway connections for EMA and FDA submissions
  • Powerful real-time reporting and dashboards
  • ICH E2B (R3) structure alignment
  • Secure, compliant and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures and EudraLex Annex 11: Computerised Systems

Eudravigilance responsible person

Pharmaceutical companies acting as sponsors of clinical trials in the European Economic Area must be registered in the EudraVigilance database system. Medfiles can help you get started and create your EudraVigilance account, update your organisation’s data as needed, create and manage your affiliates and virtual affiliates and manage your EudraVigilance users. Our experts will guide you through the entire EudraVigilance set-up process and manage the responsible person functions. We are also able enter your product to EXVMPD to have the product code for your CTIS submission.

In addition to managing your EudraVigilance obligations, we can submit SUSAR reports to the authorities on your behalf. With our certified users, we follow changes regularly and work routinely on submissions, decreasing your technical burden.

Information on investigational medicinal products must be submitted to the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), also known as the Article 57 database, and kept up to date. With our help, you can be sure that your xEVMPD is always up to date and fully compliant.

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