A biopharmaceutical company partnered with ICON for a phase 1/2 open label, dose escalation and cohort expansion study in biomarker positive patients with locally advanced or metastatic breast cancer. The study objectives were to evaluate safety, tolerability, and pharmacokinetics alone and in combination with immunotherapy.

The biopharmaceutical company faced multiple challenges during the clinical trial process. They sought a partner who could develop the necessary deliverables in compliance with regulatory requirements, while generating outputs quickly without disrupting study progress. Ensuring accuracy, completeness and reliability was critical to maintain data integrity and produce reliable results to move the study forward.

As a full-service study partner, the ICON team was responsible for the development of the study’s statistical analysis plan, and generating tables, figures, and listings (TFLs), along with tabulation dataset and analysis dataset programming using ICON’s standards and the SAS© environment.

Over a span of two years, ICON successfully produced a total of 34 statistics and programming deliverables for this study. ICON created TFL outputs for:

ICON demonstrated flexibility and true partnership with the sponsor in planning for multipurpose deliverables with short or urgent timeline requests. ICON experts also engaged with the sponsor on the original protocol and for four additional protocol amendments.

Drawing upon the strength of additional team members and leveraging time zone differences to our advantage, ICON was able to meet critical requests with speed and precision. Quality was at the forefront of our planning, even for early analyses. ICON demonstrated superior strategy in developing multipurpose code and deliveries, ultimately proving to be advantageous and cost-effective. Transparent communication and years of experience allowed us to form a strong partnership with the sponsor, fulfilling their overarching needs.