The mission of the Clinical Research Office is to strengthen Ponce Health Science University’s clinical research by providing infrastructure, quality services, and mentorship assisting new and established investigators through every stage of the research process.

Our mission is to overcome the disparities in clinical research and treatment in Puerto Rico by increasing the clinical research capacity in Puerto Rico and providing unique research experiences to Investigators, patients, and sponsors.

The Clinical Research Office (CRO) at PHSU furthers the missions of the Ponce Research Institute (PRI) of ongoing research in the basic, behavioral, public health and clinical sciences by making a difference in solving health disparities through groundbreaking, innovative and relevant research that has a global impact in health care.

The CRO provides high-level guidance and operations in the process of clinical research. The CRO enhances the excellence, scope, and efficiency of research efforts by facilitating and integrating research activities and by welcoming the pharma industry to access investigator and faculty experts in diverse therapeutic areas in Puerto Rico.

The CRO provides sponsors with access to Puerto Rico’s premier medical researchers with large and varied patient populations, a portal to experienced investigators, faculty, and research teams, dedicated, qualified staff and a centralized point of contact responsible for the development of the industry research needs from a prestigious educational and medical institution.

The CRO provides a unique experience to sponsors and investigators housed under one organization. An important goal of our team is to establish a productive relationship with industry by understanding the sponsors’ goals, timelines and providing an effective centralized contract process for timely execution.

The PRCTN in collaboration with Moffitt Cancer Center was created to overcome the disparities in oncology clinical research and treatment in the Hispanics/Latino population as evidenced by diagnosis at more advance stage, barriers to care, and underrepresentation in cancer clinical trials.

The objective of the partnership is to increase research capabilities in basic and clinical sciences, strengthen the world’s first tissue bank of Puerto Rican tumors, and establish a network and infrastructure to reduce health disparities in the treatment of cancer in Hispanic patients.

• Puerto Rico Clinical Trial Network
• Oncology Research Information Exchange Network (ORIEN)- http://www.oriencancer.org/#about

The Clinical Research Office services include biorepository for specimen processing and storage, sponsored clinical research support, and regulatory help with IRB/IACUC submission and other compliance measures.

The CRO is a multi-disciplinary service organization supporting faculty and investigators participating in federally funded, pharma, investigator-initiated clinical trials. The CRO can assist with the contracting and budgeting phases of study start-up, complete the IRB/IACUC submission process, sponsor regulatory approval processes, and provide study coordinator services.

The Clinical Research Office will also serve as a point of contact to match faculty investigators with clinical trials sponsors, expanding the network of sponsors at Ponce Health Sciences University while providing opportunities to new faculty members. The Clinical Research Office offers regulatory services for both industry-initiated and investigator-initiated research projects. The goal of our program is to conduct clinical trials of the highest quality standards and we welcome collaboration with investigators.

Study Development

• Feasibility Assessments
• Grant Management and Support
• Regulatory Submissions (Central or Local IRB)
• Investigator Selection
• Community Engagement

Study Activation

• Budget and Contract Preparation
• Clinical Trial Team
• Regulatory and IRB/IACUC Support
• Data Management
• Study Conduct
• Quality Assurance
• Financial Management
• Recruitment Planning

Study Conduct

• Clinical Research Facilities
• Coordination
• Data Management
• Monitoring
• Research Pharmacy
• Regulatory Reviews
• Specimen Collection and Storage
• Sponsor Invoicing
• Staff Training
• Subject Payment Management
• Study Closeout

The primary goal of the CRO-Biorepository is to collect a variety of valuable biological specimens from investigator-initiated studies and/or pharma to support clinical research. All data and specimens are de-identified, coded, and confidentiality protected. The CRO-Biorepository is part of the CRO-Biobank which contains the equipment necessary and provides a variety of services related to clinical sample procurement, processing, storage, and distribution.

CRO-Biobank equipment:

• -80°C freezers
• -20°C freezers
• -70 °C freezers
• Ambient Centrifuge
• Refrigerated Centrifuge
• Liquid Nitrogen Storage
• Backup Power/Generator

CRO-Biobank services:

• Specimen procurement and storage
• Specimen processing
• Specimen retrieval/distribution

The CRO can assist in the expansion of research programs by providing centralized support services for PHSU faculty and serving as a centralized resource to pharma sponsors. The following list illustrates the benefits of centralization:

• Greater efficiency through reduction in duplicate efforts and more timely processes
• Rapid response and flexibility
• Single point of contact
• Customer Service
• Expertise in process
• Compliance with training and educational program
• Collaboration with faculty investigators and associated institutions
• Turnkey model