In order to achieve this, at this point it will be your task to very accurate specify to the CRO exactly which services you want outsourced, including a detailed scope of work, if available a protocol-synopsis, time lines (expected start/completion), countries, sites, and number of patients.
If you work in a Clinical Operations, you would as a general rule usually need input from your clinical project group, i.e. from Biometrics, Regulatory Affairs, Pharmacovigillance/Clinical Trial Safety, Bioanalytical/Lab, Clinical Supplies, etc. - if these functions are available (they are not always in small biotech or device companies).
You may also need to check with your Legal, as the initial contact to a CRO at this stage will almost always require a signed CDA in order to provide more details on the outsourcing.
Your preparation so far has had the aim to find the CRO's with best reputation and capabilities within your therapeutic area of interest, but at this point, costs would be an issue for most small- to medium sized biotech or medical device companies.
Here, your job it to ensure direct comparability between the different competitive bids that you are about to receive.
How to do that? You can go on, ask for the biddings within your detailed scope of work, but do expect a hard time to make the offers comparable. What one CRO may estimate as PM (Project Managment) hours, another CRO may integrate in other costs, just to give a common example.
It will soon turn out to be a complex task to compare the biddings - and to explain clearly to your Upper Management what services they will pay for.
A better way to do it, in my experience, is to ask for your ballpark in your own predefined format, usually an Excel file or similar, describing standard tasks within all relevant functions and task, e.g. protocol finalisation, CA/EC submissions, site selections and all monitoring activities, CRF and DM, Statistics, PVG and set-up of DMC, Lab, Medical Imaging, Medical Writing - of course adopted to your specific needs.
You may also need to check with your Legal, as the initial contact to a CRO at this stage will almost always require a signed CDA in order to provide more details on the outsourcing.
Your preparation so far has had the aim to find the CRO's with best reputation and capabilities within your therapeutic area of interest, but at this point, costs would be an issue for most small- to medium sized biotech or medical device companies.
Here, your job it to ensure direct comparability between the different competitive bids that you are about to receive.
How to do that? You can go on, ask for the biddings within your detailed scope of work, but do expect a hard time to make the offers comparable. What one CRO may estimate as PM (Project Managment) hours, another CRO may integrate in other costs, just to give a common example.
It will soon turn out to be a complex task to compare the biddings - and to explain clearly to your Upper Management what services they will pay for.
A better way to do it, in my experience, is to ask for your ballpark in your own predefined format, usually an Excel file or similar, describing standard tasks within all relevant functions and task, e.g. protocol finalisation, CA/EC submissions, site selections and all monitoring activities, CRF and DM, Statistics, PVG and set-up of DMC, Lab, Medical Imaging, Medical Writing - of course adopted to your specific needs.
Your can of course ask as many CRO's that you like, but unless you have very compelling reasons, I advice to start with the first 3 on the top of your priority list.
By the way, when working out an appropriate template for this purpose of making a standardized comparision between the CRO biddings, your should stick with it, as you will learn over time that your ability to judge the fairness and competiveness of CRO ballparks and detailed cost proposals improves dramatically from one study to the next.
Was this posting useful for you? Let me know if you agree or not. Thanks. Kristian.
By the way, when working out an appropriate template for this purpose of making a standardized comparision between the CRO biddings, your should stick with it, as you will learn over time that your ability to judge the fairness and competiveness of CRO ballparks and detailed cost proposals improves dramatically from one study to the next.
Was this posting useful for you? Let me know if you agree or not. Thanks. Kristian.
Ingen kommentarer:
Send en kommentar