As part of the Bionical Emas series ‘4 things t o think about’, Medical Officer Raman Garcha outlines four areas that the medical team undertaking medical case review, within a CRO environment, should consider.
In terms of drug safety, know what the client wants and needs! This involves building a comprehensive understanding of the company, the product characteristics and study protocols. This requires planning, training and discussion. Importantly this also includes enthusiasm for the product. There is no room for complacency or assumptions in drug safety so this foundation is crucial.
2. Know the case facts
A comprehensive familiarity of the case in question; this includes knowing the clinical narrative inside out. Follow up questions and asking for more information is good practice, but only when appropriate. I refuse to believe any single medic has a knowledge that covers the entire multi disciplinary range to the depth of cutting edge research, hence further reading around the subject and consultation with colleagues for a second opinion, if necessary, can only benefit safety.
3. Interpretation and impressions
As we see so often in the clinical setting, medical opinion can be divided and that is why collaboration and working together is important for reaching a common goal. Here we use all our extensive experience in the clinical world and apply it to stringent industry and pharmacovigilance principles. This involves medical assessment of expectedness, relatedness and alternate explanations. These are thought of as the end goals in the process.
4. Quality control
I do find that sometimes there is a ‘grey’ area, where an informed and experienced opinion is applied as well as looking at the facts. We hold safety above all other principles. Hence, a thorough quality control check on all levels is important before submission. At Bionical Emas we pride ourselves on completing this process for each and every case within client led and regulatory led timeframes.
About the Author
Raman Garcha is a fully GMC registered Medical Officer at Bionical Emas. Raman has extensive experience working within both clinical medicine and the pharmaceutical industry, having worked for both niche CROs and global pharmaceutical companies.
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