Sometimes a clinical trial sponsor asks their RTSM/IRT provider to deliver something which conflicts with good design principles; of course, it’s being requested for a valid reason, but will have consequences. A good provider will first seek to understand that reason by asking “Why?” and provide a solution that avoids those consequences.
Even with over 30 years of industry experience under their collective belts, Calyx’s RTSM solutions designers would never make assumptions regarding the sponsor’s needs. By understanding the reason behind a request and what the study team really wants to achieve, they can find the optimal solution while mitigating or avoiding risk. Their experience from having built and managed all types of trials gives them a deep understanding of those potential risks.
If your IRT/RTSM provider says ’yes’ to every request without understanding your needs, you could end up with a less-than-optimal, higher-risk design that:
– Isn’t right for the life of the trial
– Isn’t easy for sites
– Doesn’t avoid data reconciliation issues
– Has no flexibility to manage future amendments
– Doesn’t meet regulatory authority obligations
– Doesn’t minimize unintentional unblinding risks
– Doesn’t best manage the specific risks of the protocol and packaging plan
At Calyx, we strive to find the right RTSM solution that meets our customers’ needs throughout the life of the trial. This includes being great communicators, from understanding those needs to explaining the “Yes but…” with proposals, solutions, recommendations, and risks.
We have the same end goal – the success of your study. For the Calyx team, success means finding the optimal design that keeps the interests of your study, your data, the sites, and ultimately the patients at heart.
When it comes to IRT/RTSM design requests, it’s not a question of ‘Can we do it?’ (that answer is always,” Yes, we can!”) It’s more a question of, ‘Should we do it?’ then ‘How can we best achieve it?’
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