MEDICAL DEVICE and in vitro diagnostic (IVD) VIGILANCE services
The Medfiles Vigilance Team provides support for both clinical and post-registration vigilance of your medical device and IVD products to ensure compliance with the European regulatory requirements. We work closely with our clinical experts and medical device and IVD regulatory experts to guarantee the best possible support for your clinical studies and post-market surveillance.
Post-registration vigilance
Post-market surveillance (PMS) is a requirement for medical devices and in vitro diagnostic devices (IVDs). It is also an important tool to actively evaluate the safety and efficacy of the product in the real-world setting. The Medfiles Vigilance Team is ready to help you with the following PMS activities:
Local and global literature screening
Literature monitoring is a key element in any vigilance system. Medfiles can manage your global and local literature screening activities, including text reviews and safety information assessments.
Incident handling
Medfiles can act as your contact point for feedback and reporting incidents. Our experts can review complaints to identify reportable and non-reportable incidents, process incident reports and provide support for collecting information for incident investigations.
If field safety notices and field safety corrective actions are required, Medfiles can manage these on your behalf. In order to detect any signals that might indicate problematic events regarding your devices, Medfiles will continuously evaluate incident reports.
Global safety database
Our services include a validated cloud-based safety database, PV 24/7. With the Medfiles Vigilance Team, our PV 24/7 database provides a cost-efficient way to process and submit your adverse event reports.
Safety alert screening from competent authority websites
We follow safety alerts from European national competent authorities and other selected countries according to your needs.
Post-market surveillance plans (PMSP) and post-market clinical follow-up plans (PMCFP)
All aspects of your products’ safety are covered in our post-market safety surveillance service.
Trend reporting and periodic safety update reports
All collected incidents are reviewed by our experts after a specified period, and the data is analysed based on the methodology specified for the MD in its PMS plan. In addition, Medfiles submits your trend reports to the national competent authorities of the countries in which the incidents have occurred.
When the submission of periodic summary reports has been agreed with the competent authority, Medfiles will support you with collecting the required information, writing the summary and submitting the report.
Clinical study vigilance
Safety review and preparation of clinical trial documents
Clinical trials require several documents linked to safety. Medfiles’ safety experts can help you with trial planning and preparation by providing comments and consultation on the protocol, data management plan, case report forms and the study report. Close collaboration between the 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 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 that regulates all safety communication during the trial. The SMP details the roles, responsibilities, processes and timelines for safety activities, 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 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 in the trial. We will prepare and review your safety management plan, with all associated forms, including your processes for reporting serious adverse device events (SADEs) and unexpected serious device adverse reactions (USADEs).
Processing and submission of serious device adverse events (SADEs and USADEs)
Medfiles has 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 and code the medical information according to standardised MedDRA terminology as well as provide case narratives, follow-up of received reports and ongoing surveillance of case reports.
Medfiles’ safety physicians assess the reported SADEs and USADEs, including review of the MedDRA coded terms, narratives and determination and documentation of the sponsor’s causality assessment. You can outsource all of these activities to us or our experts can work in close collaboration with your in-house safety physician or medical monitor.
Our safety experts prepare expedited safety reports and submissions of USADEs to competent authorities, ethics committees and investigators, as per relevant regulatory reporting requirements.
Development safety update reports
Medfiles will continuously monitor the safety profile of your investigational medicinal product. 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’ 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 Vigilance 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.
Pharmacovigilance team leaders
Satu Kujala
Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
Saara Mikkola
Head of Operations, Pharmacovigilance, EU QPPV
Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.
Saara has a master’s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.
She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.
