CLINICAL TRIAL MONITORING

What do we have?

Our CRAs are underwent the comprehensive and continuous training and coaching to be skilled, well-trained and highly motivated to provide a quality clinical research service throughout their daily tasks. Additionally, our Quality control system and the support of senior managers will reduce and minimize risks.

What do we do on this service?

Big Leap Research’s CRAs conduct monitoring visits throughout the study to:

  • Ensure the compliance with approved protocol, ICH GCP, SOPs and applicable regulatory requirements.
  • Investigator evaluation & selection
  • Remain to be communication point between both the site and project manager from study start-up through to close-out
  • Oversee data collection
  • Safety reporting
  • Review and verify source documentation, case report forms

 What do we guarantee?

In Big Leap Research, our top priority of clinical monitoring is the high – quality data. We commit to perform the highest quality review of data and better, faster information collection and analysis to ensure that client satisfaction remain at highest level.

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