Contract Research
Working with CROs
Having a good CRO to support your development can bring many benefits - experience and expert knowledge of the regulatory process amongst many others.
I have run DMPK contract studies as both customer and contractor for 25+ years.
There are many things to consider when considering contracting out Pharma research and development studies.
+ Cost (including discounts) is just one.
+ Good communication, correct study design, scientific rigor and on-time delivery are just as important, perhaps more so.
+ A study that is poorly designed and not compliant with latest DMPK-DDI guidance(s) or current scientific thinking will be money wasted and the study likely repeated, or expanded, leading to delay.
+ In contract research there are responsibilities with both the client company and the contractor - for the client these are mainly logistical, regarding timely study plan review(s), supply of certificates of analysis for the test item and arranging compound shipments. For the contractor, it's all about maintaining delivery and timelines.
+ The customer experience is also very important - how easy is it to work with the contractor?
Having experience of contracting and managing DMPK studies, from both the client and contractor perspectives is advantageous.
Finally....Drug Development is always a dynamic, changing environment. I have worked with hundreds of companies to assist them with these crucial issues of drug development and still do. By doing so, it is always evident to me how current regulatory thinking is influenced by the 'science of the day'...and it is therefore important to ensure current DMPK, ADME and DDI data sets reflect this to avoid potential unnecessary delays and/or back-fills.
It is important that your drug development partner (CRO) is aware of all the latest DMPK science.
In recent years this has certainly been true of in vitro DDI assessment and MIST strategies, where both of these crucial areas have had recent regulatory guidance(s) issued - the latest guidance(s) can be found in my Resource section.
I'm happy to advise or assist further, feel free to use my contact details.