Interfaces GMP - GCP
Complexity of clinical study designs is impacting dimension of efforts to be spent into preparation of investigational medicinal products.
To this topic EFPIA produced a short introductory video trying to present the context:
... and what about practical application ?
We know how to translate clinical designs (double blind, double-dummy etc.) into logistical and packaging concepts.
We know the practical problems with central and decentral randomisation (e.g. use of IVRS) as we are familiar with planning aspects or sudden changes becoming necessary in the supply chain during the course of the clinical study.
We think that shifting medication betweeen study sites is a result of poor planning practice and prefer to avoid such situations by communication between the parties involved well in advance. Then even shelf life extensions becoming necessary on short notice are not really frightening us.
The more hecticism is coming up the more calm we get.
GCP stands for Good Communication Practice, doesn't it ?
Foggy planning grounds ?
... is what we have experienced frequently.
Unfortunately such situations are met frequently in research and development and we thus have developed the concept of "fuzzy planning®“ to get a clear view of the needs.
Methodology is based on developing a defined requirements profile by "densifying" unprecise planning statements from the very beginning.
This requirements profile is then to contain measurable milestones in order to enable performance assessment of requirements handling.