Clinipace Worldwide to manage Prometheus oncology program

Wednesday, July 18, 2012 01:29 PM

Morrisville, N.C.-based Clinipace Worldwide, a global digital research organization (dCRO), said Prometheus Laboratories, a specialty pharmaceutical and diagnostic company, has awarded it an Oncology Program.  Immediate plans are commencing for two metastatic melanoma studies.  

Initially, Clinipace Worldwide will manage a study of Proleukin (aldesleukin) and Vemurafenib therapy in patients with metastatic melanoma (mM). This study is expected to include up to 30 sites in the U.S. with a sample size of 135 patients in the naïve patient arm.  The study is expected to enroll patients over an 18-month period, with additional follow-up of two years required.  Proleukin remains the only therapy to deliver durable remissions in metastatic renal cell carcinoma and metastatic melanoma.

A second study will compare the sequence of high-dose Proleukin (aldesleukin) and 3mg/kg Ipilimumab immunotherapy in patients with metastatic melanoma.  The study will enroll up to 120 patients at approximately 15 study sites around the U.S. 

“Patient enrollment is one of the biggest challenges we face when starting an oncology trial; thus, it was critically important for us to team with a CRO we felt could provide oncology expertise along with a robust electronic data management platform,” said Todd Butler, director of clinical operations for Prometheus. “We will be able to monitor our studies to ensure they are on track right from the start; specifically, the number of patients enrolled at each of our sites, as well as factors that impact enrollment and protocol compliance.  With the ability to monitor these critical areas in real-time, the study teams will have the ability to adjust patient enrollment strategies with improved data quality.”

“Embracing technology can be on one of the most powerful and cost-effective ways to enhance the success of a clinical trial,” said Jeff Williams, CEO of Clinipace Worldwide.  “By partnering with a digital CRO, you can be assured of safer trials and higher quality data delivered more efficiently and cost-effectively.”

 

Share:          
CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs