Drug development never stops; new molecules are clinically tested and currently available medicines on the market are constantly re-evaluated for new indications. Clinical testing of medical devices, as well as cell and gene therapies also occupy a substantial portion of clinical trials. All this means that the need for knowledge and expertise in Medical Affairs is continuously increasing.
Teamwork and excellent communication skills are indispensable and irreplaceable for success
The overall duties of Medical Affairs professionals in clinical research include providing medical and clinical knowledge gained from trials, developing clinical trial protocols, and managing team relationships internally as well as customer relationships externally. Understanding scientific concepts, reviewing and interpreting clinical data, writing and editing a wide range of clinical trial documents, as well as clearly communicating scientific and medical information are crucial elements during clinical trial conduct. Clearly described procedures and processes for performing these tasks are equally important.
Trial plans are always to be designed, planned, adapted, and executed to meet the sponsor’s expectations. Here again, well-defined roles and responsibilities assigned to each team member involved in the development of diverse trial documents lay the foundation for a functional and flourishing Medical Affairs team, enabling it to meet and exceed expectations. A functional Medical Affairs team further facilitates seamless processes across different studies and teams.
Teamwork and excellent communication skills are indispensable and irreplaceable for success. The complex nature of clinical trials requires rigorous and continuous communication between cross-functional teams, both internally and externally from the very beginning till the end. Good relationship skills based on professional attitude, responsibility and reliance are key qualities for the teamwork.
Safety monitoring – an essential component of a clinical trial
Monitoring patient safety during clinical trials is an essential component throughout the pharmaceutical product development life cycle. Prior to the marketing authorization of a pharmaceutical product, rigorous safety monitoring and evaluations from all stages of clinical trials are required. The role of a Medical Advisor is to provide objective evaluations on the findings during a trial.
Measuring safety is, however, not solely about measuring harm. From a broader view, its function is to recognize small details on valuable information to better understand the whole picture relating to the pharmaceutical product. Safety signal detection not only leads to better protection of trial participants, but also increases time and cost-effectiveness throughout the drug development process. The main purpose is to define the long-term impacts of the product which is being clinically tested on trial subjects.
The characteristics of clinical trials differ in their nature, phase of development, therapeutic indication and design, just to name a few. However, regardless of what the purpose of the trial is, the final goal of safety monitoring is always the same: to identify, evaluate, minimize, and appropriately manage risks.
Crown CRO Medical Affairs team
The Medical Affairs Unit at Crown CRO was established in 2017 with the mission to serve clients by providing medical insights and deeper knowledge in scientific issues. The team entails three Medical Doctors with a wide range of different specialties within Medical Affairs, including Medical and Safety Monitoring, as well as Medical Writing.
Egle Lukosaitiene, Medical Doctor
It may seem that there are so many common things in clinical trials. But we cannot say that our work is the same every day. Each new project usually requires new learnings, insights and skills. For me, gaining new skills is rewarding – it gives me a feeling of moving forward.
Sandra Ragaisiene, Medical Doctor
Learning about a variety of innovations and exciting new products in the pharmaceutical industry, as well as knowing that I make an impact, keeps me motivated and interested in the work.
Helga Suija, Medical Doctor
I find my role very interesting and challenging in a good way. Each day is different, and the studies vary a lot, thus, it is only natural to come across challenges that are overcome by a tight collaboration. However, I see this as a benefit for learning new things and going forward in an ever-changing environment.