Clinical Operations
Effectively managing your clinical trial planning, implementation, and results
- Develops appropriate Case Report Forms,
- Establishes and validates electronic data capture (EDC) systems,
- Manages the data from development, data cleaning, and database lock, and
- Seamlessly integrates with other systems such as laboratories, Imaging, Central Readers, ePRO, IxRS to support your clinical trials.
When you partner with MEDIcept, you’ll work with a clinical operations team that has over a century of combined experience in conducting complex studies around the world. Contact us today to learn more about how we can make your next clinical trial a timely, cost-effective success.
I need help NOW!
Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.
Need FDA or EU MDR/IVDR audit assistance?
Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.