CRO Change Order received! – Why Worry?

In the current business climate, pharmaceuticals and biotechs are facing increased numbers of uncertainties with regards to financial planning. Not only are investment funds from government agencies (NIH) being reduced, but also the user fees for the FDA are planned to increase. In order to address unforeseen financial problems, pharma and biotechs entering clinical trials need to ensure they are receiving a good return from their investment in clinical trials. Outsourcing to CROs is a crucial point in managing clinical development costs.

For many biotechs, change orders are a common experience in clinical trials. And they are an additional source of uncertainty in the clinical trial process as they entail an increase of the development costs. They might be spurred by unforeseen circumstances or emergencies or unfortunately by a lack of diligence in the clinical trial planning and budgeting process. Change orders represent a headache for project managers, as they represent the unenjoyable task of seeking management approval for the increase in budget and spending.

However, in my experience change orders do not necessarily need to bring about an increase in cost. When change orders occur, we take the time to reassess and reanalyze the financial planning of the trial budgets in total. We understand change orders as a chance to bring a list of other sections in a budget where there is room for cost reductions. Usually some budget items increase as assumptions changed, but they might be balanced out by other changes in the project where cost efficiencies allow cost reductions to be realized.

Can you imagine going to your management and announcing that there has been a 7-digit change order request from the CRO, but then being able to tell them that after several negotiation rounds the project costs did not increase? That is what we achieved to this extent only once but zero amount change orders or even overall cost reductions are not uncommon in our experience. The importance is to negotiate about efficiencies where quality and patient safety is not affected.

In order to do this, CILIQUE provides quite unique service for small and mid-sized biotechs. With our 12 years of experience in clinical trial budgeting and CRO contracts, sponsors can reduce overall clinical project costs while ensuring that the CRO spends the funds allotted in a responsible and effective manner. This process includes not only the selection of the CRO but also the negotiation of the budget and contract. Lastly, during the project, CILIQUE assists with the ever-troublesome change orders.

Project managers need to demonstrate to their management how funds are being spent in clinical trials and the ability to avoid costs increases where possible. If you are faced with cost increases in your current change order process, contact CILIQUE and request a non-binding estimate on how to alleviate your situation to give your clinical trials more financial reliability. Understand your next change order as a chance to reshuffle the cards and to play your trump card.

And: There is a solution!

The cheat sheet „6 smart questions that will reduce your change order instantly“.

Our cheat sheet will show you the six simple questions that will reduce your change order instantly. You can do this without special financial knowledge. No expensive consultants needed. No lengthy, tedious CRO negotiations. Just read our cheat sheet and follow the easy instructions.

("Signatures, Terms and Conditions, Contract - Credits to https://costculator.com/" by HAMZA BUTT, used under CC BY 2.0 / contrast improved from original)