Early Statistical Deliveries for Safety Reviews

100% of statistical deliveries made on time, with 80% made early

 

Situation

A biopharmaceutical company had a first-in-human study in patients with solid tumors.

Challenge

Cmed needed to provide regular and timely reports to the Safety Review Committee for dose decisions, to support rapid study completion.

Solution

Cmed specializes in innovative technical solutions for sponsors. By applying previous experience of first-in-human studies, Cmed:

  • Built an encapsia database to enable the sites to quickly enter their data
  • Developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee
  • Worked closely with the clinical and data management teams to reduce the time required to produce the outputs
  • Focused on the study timelines to ensure necessary resources were in place for each round of reporting

Impact

Cmed provided:

  • Data that the Safety Review Committee could rely on to be right first time
  • 100% of reports on time, 80% were delivered ahead of schedule

Case Study Key Facts    
Disease/indication Solid Tumor
Type of study First in human
Size of study 120 patients
Client type Biotech
Client base US
Project timeline 2020

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