How to streamline your study build
Successful clinical trial studies all have one key thing in common: high quality, clean data. What can make a significant difference to a clinical trial is time. Outsourcing Pharma reports that it still takes an average of more than 2.5 months to build a medical study, which is the same length of time it took before EDC systems were available. With today’s technological capabilities, why is this the case and how can releasing clinical studies be streamlined from weeks to just a few days?
Most of the challenges that arise in minimizing this time cycle stem from the way the data is structured, the training and skills of staff using an EDC or ePro and budgetary constraints reports Dr. Lamberti of the Tufts Center for the Study of Drug Development. Contract Pharma highlights “cost of amending the study design after the study was live was a significant challenge” and needs for data migration due to protocol changes as another barrier in reducing timelines. Let’s take a closer look at each of these obstacles and potential solutions that would speed up study build timelines.
Data standardization and ensuring its analysis-ready will be key in the future as technological advancements continue, reports Peterson, VP of YPrime. While he’s looking ahead and being able to easily integrate changes in technology for data, applying standardization practices right from the get go of the clinical trial during the study build phase sets you up for long-term success. It may not shave time off the process for the first clinical trial, but it can save weeks upon weeks as more trials are entered into an EDC system like ours at Trial Online as your library of templates grow.
Study Protocol Changes
Cloud based EDC and ePro solutions, like Trial Online, are part of the solution as quoted by Richard Young, “The solution is an EDC system that delivers greater flexibility in managing protocol changes and collecting new data during a trial, as well as provides a modern SaaS approach to continually deliver cloud innovation so that the system gets better over time. This would eliminate the need for database migrations altogether and, ultimately, drive much faster product development and innovation.” When protocol changes arise during your clinical study, and ultimately with many trials lasting years it may be inevitable that one does, Trial Online does not migrate databases when implementing changes. With a SaaS cloud solution for your EDC clinical trial you can further manage timelines and minimize any impacts from protocol and standardization requirements.
Training and Skills for EDC/ePro
Whenever something new is utilized, like an EDC system for a clinical trial, there is a learning and adoption period. With user-friendliness at the core and the ability to access the EDC system in a standard internet browser our system has a very small learning curve. This extends into the study build phase for eCRFs where flexibility and design are simple and intuitive for data managers and medical coders. Once an eCRF is created it can be changed if needed once the trial is active as well as added to the library function for subsequent trials.
The cost to bring a drug to market is billions, $4 – $11 billion to be exact, reports Forbes. With clinical trials reaching $100s of millions of dollars towards that final figure, it can be ludicrous to think that adopting an EDC system and using ePro questionnaire systems to communicate with patients should even be obstacles. Nevertheless small and medium sized pharmaceutical companies do have budgetary constraints to consider and this is where obtaining quotes and discussing your trial needs directly with a representative from a cloud based solution like Trial Online can make all the difference. Quantifying employee time and barriers to study builds like we’ve covered throughout this article should be considered when creating budgets. Often a clinical trial will have specific data collection needs, and working with an agile team and solution like we offer can be a cost savings that goes beyond an initial figure determined by a management team.
So let’s get going and save your organization time you can put towards patient data collection, analysis and ultimately product launch. Reach out to us today and let’s get your clinical trial going. Because your drug could be the solution many people battling illness are waiting to be discovered. Lets not let organizational red tape stand in the way of launching your brand as a game changer in the medical world. All it takes is a simple conversation to see if your needs and our solutions align so we can roll up our sleeves and get to work.