PRA International enters into partnership agreement with Oncopartners and IBPC

PRA International, a leading Clinical Research Organization, announces it has entered into a partnership agreement with Oncopartners, a leading Latin American oncology development company, and its exclusive partner IBPC, a non-profit oncology research network comprised of Brazil's largest public oncology hospitals which collectively treat an estimated 140,000 new incidences of cancer annually.  Under terms of the agreement PRA and Oncopartners will align and streamline key operational processes, thereby accelerating the planning, start-up and accrual of oncology trials in Latin America, leading to faster overall drug development timelines.   The partnership agreement between PRA and Oncopartners also provides for exclusive co-marketing and co-promotion of outsourced global oncology trials in the pre-award phase of the studies.

"PRA, as a global leader in oncology clinical development, constantly seeks innovative ways to help our sponsor clients develop drugs more quickly and efficiently, while maintaining the highest quality standards," said Kent Thoelke, Senior Vice President, Scientific & Medical Affairs, PRA. "As drug development timelines continue to be delayed globally due to lack of, or slow patient accrual, this alliance with Oncopartners and IBPC provides PRA with expanded access to patients and Brazil's leading investigators.  This partnership between Oncopartners and PRA will translate into faster study start-up, more productive development process, and shorter overall clinical trial timelines for our clients. We are pleased to announce that we are currently initiating study start-up activities on our first two collaborative studies with Oncopartners/IBPC."

"Brazil's public cancer hospitals provide care for an estimated 70 percent of Brazil's population of 190 million, and the IBPC research network provides enhanced treatment and clinical outcomes for these patients while streamlining the performance of important international clinical trials," according to Michael Choukas, President of Oncopartners.   "PRA is at the forefront of innovation in oncology clinical trials management, and our partnership represents a joint initiative to improve overall study start-up times, patient accrual and data quality metrics for our collaborative trials relative to current performance benchmarks," said Choukas.

The unique clinical research model and capabilities developed by Oncopartners and IBPC will bring a number of benefits to PRA's sponsors under the terms of the partnership being announced today:

• Rapid and comprehensive assessment of study suitability (medical, regulatory, ethical) and feasibility in IBPC public hospital network.
• Accelerated, efficient study start-up with centralized management of ethics committees, regulatory dossiers, study budget and contract management (hospital, PI, sponsor).
• Rapid patient accrual with high protocol compliance and data quality.
• An internationally experienced team of medical and clinical oncology experts with a passion for quality and a commitment to building a high performing collaboration model with responsiveness and flexibility

"Our IBPC mission is to bring more clinical trials to Brazil with enhanced treatment options for patients in our public hospitals.  The partnership with PRA will help us achieve this important goal," said Dr. Cid Gusmao, Co-Founder and President of IBPC.  "The close working relationships IBPC and Oncopartners have developed with IBPC member sites, investigators and their research staffs will provide PRA and its research sponsors unrivaled access and capabilities to perform more trials, with better enrollment and data quality, at Brazil's leading public and academic research centers," said Gusmao.

"Oncology drug development is a global undertaking, and having expanded access to patients in Latin America is vital to any development program," added PRA's Thoelke.