Choosing a CRO
How to start a clinical trial
Steps for choosing a CRO and the Start-Up Process
Client and CRO Relationship Begins
Prior to starting a clinical trial you should seek out a Collaborative Research Organization (CRO). A CRO provides the clinical expertise and resources you will need to run a successful clinical trial.
CRO Researches Company
The relationship between a CRO and a client should be 50/50. It is your job to inform the CRO of you needs and expectations for the trial and relationship, but a CRO needs to showcase their capabilities, clinical experience, therapeutic expertise, and global reach.
Decision on CRO Selection is Made
You have selected a CRO that fits the needs of your trial and the culture of your team. You and the CRO have come to the conclusion that you are the best fit for eachother and you are excited to move forward with your decision to work with them.
Budget and Contract Creation
The CRO uses their clinical, therapeutic, and regulatory expertise to put together an appropriate budget and contract that will be a realistic estimate of the timeline and expectations of your trial.
Needs of the Clinical Trial are Defined
The client and the CRO work together to establish the needs of the trial. The CRO looks at the market, competitors, regulatory requirements, an global feasibility to assess the needs. These components will set the guidelines for the trial design.
CRO creates Trial Design
A unique trial design is created for your study. Components of a trial design include the goals of the project, the processes and services that will be utilized to achieve those goals, the possible challenges that the trial will face and appropriate action plans, and a realistic timeline.
Adjustments and Amendments to Trial Design
The trial design document will lay the groundwork for the entire clinical trial process. It is important that the document it is approved by both parties. This step takes time and requires design iterations and changes to ultimately create the most efficient trial design that will lead your study to success.
Complete Start-up Services
Once the Trial Design document has been finalized and preliminary start-up services, such as EDC and operations, have been wrapped up it is time to move forward to preparing for the clinical trials. This will include a period of FDA submissions and approvals.
Choose CRO Services
By assessing the trial design document the client and the CRO will agree upon the specific services and roles that the CRO will be allocated. The CRO will then assign the appropriate resources and staff and define roles and expectations. Teams will be briefed on the trial details and project timeline and will start establishing relationships.