CMC Monitoring
Run CMC on Your Own
In case your have any doubts about the true performance of your CMC sector, our CMC Monitoring may be a perfect choice for you.
Have a Safety Net at Hand
Receiving any amount of data, certificates or reports from CMC partners may be a positive sign – or it may not. Better to check in a smart way.We believe in Triple-A monitoring: Absence of important deliverables, Adherence to overall planning and Adequacy as far as your objectives and requirements are concerned.
In other words, not receiving an important deliverable (Absence) is bad. But receiving a deliverable too late (Adherence) is just as bad. And receiving something in time that does not match your requirements (Adequacy) can be even worse.
While your organization runs the CMC process, we will run Triple-A checks in the background. Use our expertise to build your external safety net. Get early warning about any risks, deficiencies or upcoming challenges in the CMC field. Together with detailed suggestions for corrective action.
CMC Monitoring – safety net for Biopharma management.
Data Based
CMC Monitoring is mostly a quiet activity. At project start we discuss your detailed project plan, timelines, dependencies and so on. After that you just send us all data you receive – lists, mails, reports, CoAs, contracts, in short everything that relates to your CMC activities. Once we receive your data we will check in the background- Absence – is anything important delayed or just plainly absent?
- Adherence – are your partners complying with your plans and intentions?
- Adequacy – does the reported result match your requirements?
Stay Informed
No battle plan survives first contact with the enemy. CMC plans follow this rule exactly. API synthesis fails completely. Analytical testing gives OOS results. Some new impurity appears. Up scaling does not work. Clinical trial supply has stability issues. Validated analytical methods fail to deliver reliable results.Detecting deviations from plan early enough is crucial. Our experience in CMC helps a lot with that. Our experience tells us what can go wrong and what is notorious for creating disaster. Our experience allows us to read between the lines of too optimistic reports. Our experience gives us the chance to spot plain mistakes fast and reliable.
And our experience enables us to go two steps beyond detecting what is missing, deficient or just plain wrong. We can estimate the potential impact of any issue and we can define appropriate corrective measures. Is a failed API up scale a total disaster because clinical trial supply will not be in time? Or is there a time buffer hidden somewhere? Could the loss of time be compensated by re-scheduling activities? Is there any other trick to meet clinical trial timelines?
Decades of CMC work resemble hundreds of different disasters, potential corrective measures and the experience what might work and what is doomed to fail right from the beginning. We bring this entire expertise to our CMC Monitoring projects. We constantly check for Absence, Adherence and Adequacy, allowing clients to operate CMC on their own.
Run CMC on your own. Have a safety net at hand.