Phase IIb Trial Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer

This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer. Novotech, a leading CRO, played a pivotal role in overcoming the complexities of this oncology trial, managing patient recruitment and multi-site coordination across three locations.

The trial involved 40 patients, and Novotech’s strategic approach enabled full recruitment within 15 weeks—10 weeks ahead of schedule—despite strict inclusion and exclusion criteria. Novotech’s deep oncology expertise and strong relationships with local regulatory bodies was key to this success, which expedited ethics approvals and site activations. Novotech provided comprehensive trial management, including regulatory navigation, site liaison, clinical supply management, and patient monitoring. Their proactive approach ensured adherence to timelines, allowing the sponsor to gather critical data earlier than planned. The resulting accelerated timeline not only facilitated early study closure in March 2023 but also reinforced the sponsor’s confidence in Novotech’s capabilities. The success of this partnership sets the stage for future collaborations, demonstrating Novotech’s ability to execute complex oncology trials efficiently while maintaining high-quality standards.