Global Full-service Phase III Ovarian Cancer Study

Catalyst Oncology succeeds in delivering for late clinical-stage oncology biotech.

While the biotech had experience working with Catalyst in an early phase development program in a different indication, Catalyst Oncology’s abilities to address a global full-service Phase III study helped to rescue the client’s ovarian cancer research.

A biotechnology company approached Catalyst Oncology to provide full-service CRO support to rescue their Phase III registrational study. The company had contracted with a large CRO, who were failing to deliver on study start-up activities, were unresponsive, and showed no flexibility to fit the Sponsor’s needs. The biotech had worked with Catalyst previously on an early phase development program in a different indication. This clinical trial for ovarian cancer involved ~400 patients and 136 sites across 12 countries in North America, Europe, and the Asia-Pacific region.

Catalyst Oncology delivered this Phase III study and provided client support including:

Solution

Flexible

Full-service flexible offerings, such as project management, start-up, clinical monitoring, data management, biostatistics, medical monitoring, and clinical science

2 weeks

Mobilized and onboarded a study team within two weeks with an established a governance structure

82,000

Source data verification (SDV) and data review of more than 82,000 electronic case report forms (eCRFs) were completed

80,000+

queries were issued and closed with an average site response time of 14 days

12,000+

terms were coded

Outcome

Catalyst Oncology delivered on a global Phase III ovarian cancer trial with 400 patients with full-service accountability on time and ready for regulatory submission.

Delivered flexibility for the Sponsor

Successfully completed a mid-study database change from the previous CROs out of date EDC technology to alternative new EDC system

Completed patient enrollment on time

Database lock occurred on time and within six weeks of the last subject/last visit (LSLV)

Topline tables, figures, and listings delivered on time and withing seven weeks of LSLV