The first direct contact - ensure comparability between competitive biddings

Your first contact with your initially preferred CROs will have the aim of evaluating in-depth whether these your CRO's of choice are really appropriate for your planned clinical activities.

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.

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.

Which CRO's to choose? The initial considerations

Your initial considerations on finding suitable CRO candidates for your clinical trial can be based on a variety of issues. In my experience, a very good place to start is your previous experience combined with good old recommendations from trusted colleagues.

However, do not let that stand alone - you may risk overlooking an even better candidate CRO, and also remember, that this market is in rapid change, and experience gained 2-3 years ago may already be outdated.

Always seek what general information you can find available on suitable CROs within the therapeutic area in case. A careful conducted litterature review on recent clinical trial conducted within the clinical indication of interest may reveal not only CRO-candidates that you would not have been thinking of, but also Key Opinion Leaders and potential investigators - plus it may give you a hint on countries and regions with relevant clinical activities.

Three critical questions to ask when selecting a CRO

Q1: First, ask which functions should be done in-house or outsourced?
Base your answer on a careful analysis of what is value-adding for your company
If you're a small biotech, it it rarely value-adding to do e.g. Datamanagement in-house, establishing a validated DM-function. In contrast, establishing in-house statistical capabilities may add value, as it brings your company closer to your own data

Q2: What will be the key driver in the CRO selection that could affect Speed and Quality of the Trial?
Base your answer on a careful analysis of all relevant factors that could impact study start-up, conduct and completion, e.g. :
Protocol feasibility and site selection
Managing data quality (monitoring, electronic data capture, records)
Balancing sponsor resources vs. external resources

Q3: What will the study cost - what will it REALLY cost?
Identifying costs and developing realistic budgets is a difficult and timeconsuming exercise. When you get CRO cost-proposals, remember that even full-service CRO's may need to have subcontractors, e.g. medical imaging, lab, drug supply, etc - these additional costs need to be in the budget that YOU present to your Senior Management! You will not want to come back to ask for bigger budgets, because you did not get the full picture first time. Learn from former experience, but remember that clinical trials are always unique in some way or another.