We’ve written a few articles about tips for conducting clinical trials and in doing so working with CROs (clinical research organizations or contract research organizations). Here we consider 5 simple tips for selecting the best CRO for a trial and also tips for how to work with such organizations.
- Choose a CRO which shares your organization’s mission and values or stipulate what specifically needs to be done in the trial to ensure these are carried out and followed. One of the possible disadvantages that can arise from working with a clinical trial research organization can arise as a result a difference in mission and values between. For example, it may be very important to your own organization that all participants in the trial are given adequate opportunity to voice any concerns they have about anything related to the trial. If this is the case choose a CRO that shares this same value and/or communicate to the CRO and stipulate what specifically needs done in the trial to ensure your company’s mission and values is carried out i.e. stipulate the channels and manner in which all participants will be able to communicate about the trial.
- Consider what the end goal is of the clinical trial and choose a CRO organization that is best equipped to help you reach that end goal. This may include things such as considering what is the population to whom you want to market and sell the end product and whether the population the CRO proposes to test the product upon is a similar one. This may also include taking a holistic approach of all that needs to be done for the trial to be conducted properly and effectively and researching which CRO has all the requisite and up-to-date human resources and clinical resources for doing so. Choose the CRO which overall is most suited to achieving for you what you aspire the clinical trial to achieve.
- Consider what your company’s security and intellectual property needs are for the clinical trial and do your due diligence to ensure you find a CRO that is in the best position to keep all information secure and confidential. This may also include considering which CRO will conduct the trial in a country where laws and regulations are set to protect confidentiality and intellectual property in a manner with which your company feels comfortable. It may also be a good exercise to put in writing not only what the requirements are for ensuring protection of intellectual property and confidentiality but also to stipulate in the practical mechanisms that will be put in place to ensure this is done.
- Prepare a detailed communications plan for how you are going to communicate throughout the entire clinical trial process with the CRO. Doing this will make it less likely that mistakes or unforeseen issues will arise due to miscommunications. This may include details of:
- which people from your own organization and that of the CRO are responsible for communicating about and verifying the status on various specific aspects of the clinical trial;
- how often reporting on the status of the trial will occur; and
- on which specific elements of the trial the reporting will be made upon.
- Create a crisis management plan for the possibility that something could go wrong. Consider what things could potentially go wrong during the trial and devise a detailed plan for how to best respond. For example, consider who will be responsible for dealing with the crisis and what processes and procedures will be followed to ensure it is resolved. Thinking ahead and planning for these eventualities will minimize the negative impact such crisis may otherwise have on the clinical trial.
So there you have 5 tips for choosing which CRO with which to work and also how to go about managing your relationship with them. What are your thoughts? Have you been involved in a clinical trial and/or worked with or for a CRO? What advice would you give to professionals engaging in such a partnership?
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