Case Study - Mitigating Pharmaceutical Development Risk
Challenge - Ensure additional patient data needed for a regulatory filing are collected in a very short period of time
Situation - In the middle of a fast enrolling Ph2 clinical trial, it was determined that additional patient data would need to be collected for a Health Authority prior to database lock.
Solution - After a short preparation period, a two day off-site meeting was held with functions needed for collection of the data. Activities and the time needed to complete them were reviewed as well as their interdependancies. Not surprisingly, the time needed for all the activities was more than available, however, with effective team work the timeline was shortened. Through this process activities with significant risk were identified and mitigations/contingencies were agreed and implemented for those that were deemed to most likely to occur and have the biggest impact on the data collection.
Outcome - Establishing clarity and transparency resulted in flawless team work so that as the data were collected everyone was aware of what they needed to do as well as how it impacted other activities. Some of the identified risks did occur but because they were known up front the team was prepared. Ultimately, the data were collected and added to the database in the required time frame.
How S3B can help you mitigate risk? S3B will work with your staff to ensure all information needed prior to the meeting is available and will facilitate the meeting. S3B will provide your organization with a log to assist your team in execution.