1. Think about your process
Is there a seamless transition through each stage of your process, from receipt of case to expedited reporting of an ICSR?
If the answer is no, then review your process. You should continually review how to improve existing processes and actively seek solutions. Look out for bottle necks or any duplication of effort, as these can have a negative impact on achieving compliance and quality. A successful process will deliver consistently high quality case processing at a large volume.
2. Create clear, precise SOPs and working instructions
Once you have an efficient process in place – document it. Capture every detail in standard operating procedures (SOPs) and working instructions.
Review your documentation to ensure that every case processor can follow them easily, avoiding misinterpretation. Clear, precise instructions will ensure uniformity across your team regardless of experience. Remember, non-compliance with SOPs will be highlighted during audits and inspections – get them right and to stick to them.
3. Understand your client
Process and documentation are key to case processing but each client is unique. Client specific procedures for individual products need to be understood and accommodated. Ongoing communication with your client will ensure changes, such as a new safety database or new product can be planned for with appropriate training and processes.
A well prepared and informed case processor = higher quality and a happy client
4. Manage the pressure of tight deadlines
It is 3pm on a Friday afternoon. You have multiple deadlines to meet by the close of business – a scenario familiar to many case processors. Use effective communication with your manager, team members and clients to make tough deadlines achievable. Delegation or working beyond your normal leaving time are all options to be explored to ensure cases are processed on time.
About the Author
Matt Tutton our Case Management Team Manager has worked for almost a decade in clinical research, within global pharmaceutical companies and contract research organisations (CROs).
If you would like to talk to one of experts or discuss how Emas can support your development program then please do contact us at firstname.lastname@example.org