Clinical Trials Safety
Safety review/preparation of clinical trial documents
Clinical trial consists of several documents liking to safety issues. Medfiles safety experts assist on trial planning and preparation by commenting e.g. the protocol, data management plan, Case report Forms, study report. The close collaboration between safety and clinical and data management team from the beginning of the study planning is essential to ensure the adequate safety data collection for you trial.
Medfiles clinical safety experts can prepare all your trial-specific Pharmacovigilance training materials and conduct all the applicable training for your personnel at study sites during Investigator Meetings and Site Initiation Visits.
Safety management plans
When conducting clinical trials the Safety Management Plan (SMP) is one of the key documents regulating all safety communication during trial. The SMP details the roles, responsibilities, processes, and timelines for safety activities. It ensures a systematic approach to safety monitoring and promotes early issue detection to help mitigate any safety risks in clinical trial subjects.
Medfiles clinical safety experts can assist you on the best way to set up the safety management of your trial, taking into consideration the study phase, indication, subject, other parties involved in the trial. We can prepare and review your safety management plan, with all associated forms, including processes for Serious Adverse Event (SAE)/ Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting.
Processing and submission of Serious Adverse Events (SAEs and SUSARs)
Medfiles is processing serious adverse event reports received from the study investigators. The experienced team at Medfiles will conduct triage of case reports to determine seriousness and causality, enter the data into our pharmacovigilance database, code the medical information according to standardised MedDRA terminology and provide case narrative, the follow up of received reports and ongoing surveillance of case reports.
Medfiles physicians can assess reported SAEs and SUSARs including: review of the MedDRA coded terms, narrative review and determination, and documentation of the Sponsor Causality Assessment. This can be done independently from your operations, or in close collaboration with your in-house safety physician or medical monitor.
Medfiles experts can prepare expedited safety reports, including cover letters, electronic submission, and local submission of SUSARs to Competent Authorities, Ethics Committees and Investigators, as per the relevant regulatory reporting requirements.
Medfiles is providing you a cloud-based validated safety database PV 24/7. With Medfiles pharmacovigilance data management team you have cost effective way to process and submit your adverse event reports. We can collect the data from one study or integrated global data base from all your studies to have data collected efficiently for cumulative safety analyses.
PV 24/7 is providing:
- Continuously updated to the latest regulatory requirements
- Direct gateway connections for EMA 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: Computerized Systems regulations
Development safety update reports
Medfiles will continuously monitor the safety profile of your investigational medicinal product. The Development Safety Update Report (DSUR) provides a comprehensive overview of your investigational medicinal product’s benefit-risk evaluation and compliance with applicable regulations. Medfiles is providing DSUR writing and submission during the developmental phase of your product.
Eudravigilance responsible person
Pharmaceutical companies’ which are sponsors of clinical trials in the EEA must be registered in the EudraVigilance database system. Medfiles can create your EudraVigilance account, update your organization’s data as needed, create and manage your affiliates and virtual affiliates, and manage your EudraVigilance users. Medfiles can guide you through the whole EudraVigilance set-up process and manage Responsible Person functions.
Our experienced experts can manage Eudravigilance and submit SUSAR reports to authorities on behalf of you. Medfiles has for a system a EMA? certified user which is required. Our team follows the changes regularly and is working routinely on submission decreasing your technical burden.
Investigational medicinal product information must be submitted to the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), also known as the Article 57 database, and keep this information up-to-date. With Medfiles team your xEVMPD is updated and fully compliant.