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How to enhance the progress of your study by improving data quality standards

When conducting a clinical trial, the main goal is reliable and clean data
to support the investigational product effectively and safely.
 
Did you know?
Up to 30% of data collection is not used for data analysis due to ineffective
protocol design.
Approximately 25% of procedures in protocol are not associated with any
key endpoints (primary, secondary, treatment or exploratory).     
 
Better Design:
  • Clearly define the endpoints and measures – Straight-forward and intuitive endpoints, will save time and money.
  • Simple endpoints are more effective for marketing purposes and prevent regulator confusion. Clearly written protocol minimizes work and time efforts and enable faster patient enrollment.
  • Focus on the Essential procedures, Collect only necessary data, to draw conclusions about study hypothesis by “Connecting” the procedures to the study objectives.
  • Reducing complexity and unnecessary procedures, lowers the risk of deviation/non-compliance by the site.
  • An efficient study design may require fewer subjects while providing the same results (sufficient power to demonstrate an effective and safe drug or device). Smaller sample size – > less Data to collect – > less resources.
  • Clearly define the eligibility criteria to avoid screening and enrollment errors.
  • Clearly define the standard of care and match it to the Protocol. Ensure all investigators are aware of it.
  • Avoid multiple secondary objectives to reduce site burden.

Better planning:
 

Improving the efficiency of monitoring is one of the largest
cost control drivers in clinical research today.

  • Remote monitoring is an alternative approach to maintain trial participant follow-up during the study, keeping all clinical monitoring, and communication with sites on track, while reducing on-site visits.
  • A risk assessment remote monitoring plan should be prepared before applying the remote monitoring, in order to maintain study and patients’ safety.
  • Sponsor should consider combining “remote follow-ups” visits using advanced platforms such as:  
* eICF
* e-Pro
*Video visits (webEx, Zoom,TCs, etc.)
* Home nursing

Our team will be happy to introduce our clinical services and
assist you in implementing your study effectively

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