During a clinical trial, a number of hurdles can be encountered that can put human subjects at risk, result in costly delays and even compromise the integrity of the study. Having third-party oversight from a compliance-minded contract research organization keeps your trial on track and prevents human subject protection issues or data integrity issues from derailing your quest for approval.
IMARC Research can support your team at any point in the process, or manage your entire project, serving as a single point of contact between all stakeholders.
On average, 80% of clinical trials experience delays of 1-6 months, costing thousands of dollars per day.
Having a proper understanding of the risks and a plan for mitigating them helps teams avoid costly delays.
Clinical research investigations are required to be conducted in accordance with the applicable regulations, signed agreements, the investigational plan, and other conditions of the IRB or FDA, according to 21 CFR 812. Having complete, accurate study documentation is critical, and IMARC will ensure data is clean for analysis and reporting.
Your trial plans, resources and vendors set the foundation for your entire trial. Making mistakes in these early stages can have a snowball effect, causing bigger issues later.
Understanding the innate risks in clinical trials and setting up a plan to mitigate those risks can be key in ensuring a well-controlled clinical trial.
This stage of a trial tends to be the most chaotic, with many moving parts and opportunities for error. Mistakes or delays can quickly derail the trial.
A clinical trial has many moving parts that must work together efficiently. There are multiple communications to manage between points of contact and key milestones to meet. To keep everything running smoothly, it’s important to have someone who can see the big picture.
IMARC Research is a medical device CRO with nearly two decades of experience ensuring patient protection, data integrity and regulatory compliance at every stage in the clinical research process. We have a stellar record with the FDA and the expertise to navigate the complexities of medical device studies. Revisit the clinical trial lifecycle.