Clinical Operations

The clinical trial phase is where new medical device development often fails because of poor planning or execution. In fact, many clinical trials fail because of the lack of a structured, practical, and business-like approach to trial management. That is why it is so critical to work with an experienced clinical operations team that can successfully develop, implement, manage, and report your clinical trial and its results.

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Effectively managing your clinical trial planning, implementation, and results

Clinical trials are sophisticated operations that require clear focus, attention to detail, and efficient management of all phases. Because a clinical trial is only as good as the data it produces, our clinical team: 

  • 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.