ICH E6 (R2) provides meaningful additional guidance. In regards to
improving study designs, we’d like to call your attention to statements
in Section 5. At the very start of this section it states,
“The sponsor should implement a system to manage quality throughout all stages of the trial process.”
Taking this a bit at a time, let’s first look at the phrase ‘implement a system to manage quality’. Clearly, the emphasis is on having a system in place to focus on quality. It is always better to pursue a policy of Quality by Design, rather than try to test for quality then weed out defects after the fact. The best place to initiate quality is at the beginning of the process. Intilaris specifically focuses on providing services and solutions to build quality in at the start of clinical trial planning.
Now a system does not have to be a computerized system, but use of one can definitely help. At initilaris, we recognize that no computer system alone will ever be sufficient to address the complexities of clinical trials. Yet at the same time, the complexity of clinical trials call out for the use of computerized systems to comprehensively track and manage all the elements of this complex endeavor. That is why, initilaris’ solution is based on a comprehensive set of consulting and support services facilitated by a platform of computerized tools.
Next, let’s look at the phrase “throughout all stages of the trial process”. There are numerous systems developed to support trial tracking, data collection and reporting. But all of these neglect the key principle of building quality in at the start of the process – the study design. Intilaris focuses on this crucial piece of the process. We start at the beginning with the clinical project plan and feed this through to the individual trials and downstream processes. By doing so, you build quality in at the start of the process and reap benefits throughout the trial and the entire clinical development program.
This process enables you to meet the goal exemplified by the ICH statement:
“Quality management includes the design of efficient clinical trial protocols and tools and procedures for data collection and processing, as well as the collection of information that is essential to decision making.”
The opening phrase “Quality management includes the design of efficient clinical trial protocols” gets to the essence of our solution – Build Quality In. The only way to build quality into a process is to start at the beginning, by building quality into the study design process that produces the protocols.
The next part of this sentence goes on to “tools and procedures for
data collection and processing”. Our approach assures that the study
design elements are captured so they can be fed to the downstream tools
and procedures. All of which feed into addressing the next 2 sentences
“The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection. Protocols, case report forms, and other operational documents should be clear, concise, and consistent.”
The intilaris solution is designed to vet all the procedures and requested data to assure the entire team understands why the data is being collected and how it is going to be used. This approach purges unnecessary procedures and challenges undue complexity. By starting at the clinical project level and feeding design elements to downstream systems, consistency between studies and consistency between systems is maintained.
We all know that quality is of paramount importance, especially in clinical trials. At intilaris, we enable you to assure quality starts at the beginning – where it belongs.