Integrated CRO & Clinical Consortium
Advancing the science of cancer clinical trials
The PCCTC is a full-service integrated CRO and clinical consortium built on two decades of leadership in genitourinary oncology. Our renowned investigators, network of 200+ research sites, and industry-grade CRO services now extend across oncology, completing efficient, process-driven clinical studies that translate scientific discoveries into improved standards of care.
What we do
A flexible research partner, from concept to close-out
The PCCTC is changing how cancer therapies and biomarkers are developed. Our infrastructure enables transparent project co-development between investigators, clinical research sites, and industry partners.
Trial Design and Development
PCCTC investigators and operations staff work with sponsors from first concept to finished protocol, so the design answers the scientific question and can be run efficiently at the sites that will enroll it.
Learn moreProject Management
From concept to close-out, the PCCTC's Clinical Operations team keeps studies on time and on budget, coordinating sponsors, investigators, sites, and vendors through a single accountable point of contact.
Learn moreClinical Data Management
Standards-driven data management built on Medrio EDC and reusable CDISC-conformant libraries, following Good Clinical Data Management Practices and current FDA, ICH GCP, and GDPR requirements.
Learn moreData Science and Statistical Analysis
PCCTC biostatisticians, statistical programmers, and data scientists are involved from protocol and statistical analysis plan through final reporting, combining modern, reproducible computing practice with strict GxP compliance.
Learn moreRegulatory Services
The PCCTC coordinates regulatory document management across a project's lifecycle and serves as the single regulatory point of contact for sponsors and investigators, shortening the path from protocol to activated sites.
Learn moreMedical, Site, and Centralized Monitoring
Medical monitoring, on-site and remote site monitoring, and centralized data surveillance run together under PCCTC SOPs, so safety signals and data-quality issues are caught early in every region of a study.
Learn moreCorrelative Science and Laboratory Services
Correlative science is integrated into the studies we manage, from assay validation to specimen logistics, grounded in active research at our academic medical centers and biopharmaceutical partners.
Learn moreMedical Communications and Writing
Our dedicated medical writer and editor, both with oncology expertise, work with investigators, sponsors, regulators, and publishers across a project's lifecycle, from protocol to peer-reviewed manuscript.
Learn moreRegistries and Real-World Evidence
The PCCTC designs and operates large multicenter registries on the infrastructure behind the international IRONMAN registry and the PCCTC-managed PROMISE germline registry, and is extending the model to colorectal, breast, and lung cancer.
Learn moreQuality Management
A dedicated quality function maintains the SOPs, study-specific plans, and oversight that keep every PCCTC-managed study inspection-ready.
Learn moreContracts and Budgets
Budgeting and contracting tools, built for multicenter research, speed activation and set consistent terms across institutions.
Learn moreAdvisory Boards and Clinical Development Consultation
Targeted advisory support without a full outsourcing commitment: advisory boards of leading academic investigators, clinical development strategy, study design, and operational and site feasibility.
Learn moreOur expertise
Internationally recognized experts in oncology
PCCTC investigators practice at the world's top academic medical centers, where they run active translational research programs. They developed the universally adopted clinical states model of prostate cancer and led the endpoint-validation efforts behind PCWG2, PCWG3, and PCWG4. That trial-design depth now anchors the consortium's growth into new disease areas.
Meet the consortium- Over 200 participating clinical research sites worldwide
- Co-development of novel therapies and predictive biomarkers
- Leadership in trial design, endpoints, and imaging standards
- A collaborative culture spanning academia and industry
- Registry programs extending into colorectal, breast, and lung cancer
Study portfolio
Featured studies
Our trials span the entire disease continuum, strategically aligned with the most promising targets and biomarkers in development today.
STRIKE-001: Phase 1 dose-escalation study of KTX2001, an NSD2 inhibitor, alone and with darolutamide in metastatic castration-resistant prostate cancer
NCT07103018Visit study Randomized · PCCTC-sponsoredTALENT: Talazoparib with or without enzalutamide in metastatic castration-resistant prostate cancer with HRR mutations after abiraterone
NCT06844383View study Phase 2 · Investigator-initiatedTIDAL: Phase 2 study of tarlatamab in DLL3-positive metastatic prostate cancer
NCT07111507Visit study Registry · Real-world evidenceIRONMAN: International Registry for Men With Advanced Prostate Cancer
NCT03151629Visit studyLatest news
From the consortium
Partner with the PCCTC
Our team provides full-service study management and functional service provider support, accelerating the activation, accrual, and completion of multicenter clinical studies.