Regulations on clinical research are constantly changing

It is important to know that different competent authorities and ethics committees release different decisions on the same protocol/ICF. The evaluations are different and made under either scientific, technical and/or patient-safety aspects.
At easyClinical, we believe that regulatory aspect is the cornerstone of the trial success. Our team can support you in identifying the needs, preventing pitfalls and avoiding delays in initiating your clinical study.

What We Do?

  • Preparing specific study regulatory plan
  • Submitting high-quality applications to Ethics Committees and Competent Authorities, with country-specific requirements, including amendments
  • Clinical Trials Information System (CTIS) completion & submission
  • 510(k) notification to FDA
  • Public registry registration (Clinicaltrial.gov, others)
  • Study notification of study start/closure to EC/IRB/CA
  • Submission of Annual Reports/ DSUR
  • Study insurance management
  • Supporting sponsors in preparing product technical files
regulatory affairs

Capabilities

Strategy

A business strategy is the means by which it sets out to achieve its desired ends.

Audit

If you have been selected for a business audit, here is what you need to know.

Restructuring

Restructuring your company could restore its viability and improve its liquidity position.

Benefits

Marketing Research

Research helps you plan the best way to get your product from the manufacturer to the retail shelf. In addition to deciding which retailers should carry your product, you should determine where your inventory will be held.

Listen to your team

Go to your team, and tell them you want to make a fresh start. Tell them you want them to enjoy their jobs more and get more done.

Analyze the Problem

In this problem solving step, you will want to figure out what caused the problem, what the problem looks like at this moment, and the urgency of addressing the problem.

Insights

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July 30, 2024
Que fait-il inclure dans un article de blog ? Un contenu utile sur l’industrie, qui : 1)...
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