Anna Lyra works at Medfiles as a Senior Clinical Research Associate (Senior CRA) and Medical Writer. She has more than 20 years of experience in clinical research and related scientific and medical writing. Over the years, Anna has also worked at Medfiles as a CRA and Scientific Advisor.
Anna holds a PhD in microbiology. Her doctoral research focused on changes in the gut microbiota in people with irritable bowel syndrome. She has continued to develop her expertise through training in areas such as clinical research regulations, GCP requirements and medical writing.
Clinical research for medicinal products, medical devices and food – from planning to implementation
Anna works with studies involving medicinal products, medical devices and food products. Her work combines clinical study monitoring and coordination, project management, scientific and medical writing, and various expert assignments. Her working days range from focused writing and review work to collaboration with clients, study teams and study sites.
In scientific and medical writing, Anna prepares and updates documents such as study synopses, protocols and reports, as well as other documentation required for the conduct and documentation of studies. Depending on the subject area, her role may involve either general or subject-specific expertise.
One of the strengths at Medfiles is close collaboration between experts from different fields. When needed, experts in medicinal products, medical devices, food regulation or other areas can quickly be brought into a project. The aim is to meet each client’s needs as well as possible and within the agreed timelines.
Anna’s work also includes internal responsibilities at Medfiles, such as preparing proposals and standard operating procedures (SOPs).
Broad experience provides a comprehensive view of clinical research
Anna’s work requires the ability to move between detailed document work and managing the study as a whole. This is one of her strengths, built on broad experience across different types of studies, roles and working environments. She has worked with food, medical device and medicinal product studies as a researcher, project lead and coordinator, monitor and medical writer, as well as being responsible for the practical operations of a research clinic. Her experience spans university research, an international sponsor organisation and the CRO environment.
My broad background helps me understand both the scientific content of a study and how a study is planned, conducted, documented, monitored and reported in practice. My experience also helps me assess already at the planning stage which ideas could work in practice and how a study should be conducted to achieve its objectives and produce reliable results.
Anna’s extensive experience in study planning and reporting also supports her work as a monitor.
The more carefully a study is planned, conducted and documented, the less there is to explain at the reporting stage.
Anna’s background as a researcher of the human microbiota and her natural enthusiasm for expert work add further depth to her expertise.
Variety and meaningful work
At Medfiles, Anna particularly values the variety of her work and the opportunity to contribute to meaningful research.
It is rewarding to be able to contribute to important science and research. I have often been genuinely impressed by the quality of the studies, as well as the expertise and team spirit of the research teams. It leaves a positive impression for a long time, even when my own involvement has been limited to a single-day monitoring visit.
The colleagues around her and the opportunity to draw on Medfiles’ broad expertise are also important aspects of her work.
I particularly value having skilled and friendly colleagues around me who trust each other’s work. We have a broad range of expertise, and we work together to find solutions that meet our clients’ needs.
Medfiles’ clinical research team provides comprehensive and tailored support throughout the different stages of clinical research, from study planning to final reporting. Our experts have more than 20 years of experience in clinical research and regulatory requirements for studies involving medicinal products, medical devices and IVDs, and food products. Support is available for individual stages of a study as well as for the entire study.
Free webinar: Medical device clinical evaluation and investigations
In this webinar you will learn if your medical device is in a need of clinical investigations. You will also learn about properly documenting a clinical evaluation, including how to compile a clinical evaluation plan and a clinical evaluation report according to the requirements in the MDR. In the webinar we will also give practical tips for ensuring that your clinical investigation meets the needed GCP requirements and none of the essential elements are forgotten.
