Services

The trusted CRO for oncology research

The PCCTC supports both full-service study management and functional service provider (FSP) project support. Industry-grade services, global consortium engagement, and deep scientific expertise accelerate the activation, accrual, and completion of multicenter clinical studies.

How we engage

One partner, multiple ways to engage

The PCCTC's collaboration models flex to match your program's scope, timeline, and internal capacity.

Full or partial service CRO execution

  • Fully outsourced trial management across all CRO services, with transfer of sponsor obligations.
  • Partially outsourced models with clearly defined transfer of sponsor obligations.
  • Scalable engagement that expands or contracts scope as the program evolves.

Ideal when a program needs a single accountable partner from start-up through close-out.

Flexible consulting model

  • Advisory boards
  • Clinical development strategy
  • Study design
  • Operational feasibility and project start-up
  • Site feasibility

Targeted advisory support without a full outsourcing commitment.

01

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.

  • Concept development and protocol writing with investigators who set the field's trial-design and endpoint standards, including PCWG4.
  • Designs from first-in-human dose escalation to randomized phase 2 and registrational phase 3, extending more recently to adaptive, multi-arm platforms.
  • Designs aligned with current FDA guidance, including Bayesian optimal interval (BOIN) dose finding and master protocols.
  • Operational and site feasibility assessed during design to support rapid activation timelines and reliable accrual projections.
  • Patient advocacy efforts supported by Your Prostate Cancer. Help.
02

Project 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.

  • Strategic selection of regional and international partners and participating sites, tailored to the study population.
  • Sponsor- and study-specific management plans keep sponsors, sites, and vendors aligned.
  • Clear, technically feasible timelines with milestone tracking, enrollment dashboards, and regular site engagement.
03

Clinical 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.

  • Standards-based CRF libraries aligned to CDISC CDASH and prospectively mapped to SDTM/ADaM.
  • End-to-end compliance with 21 CFR Part 11, the FDA Data Standards Catalog, and EU/UK GDPR.
  • An Integrated Data Review Process embeds biostatistics, data science, and clinical operations review at every milestone, with real-time investigator access through encrypted portals and APIs.
04

Data 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.

  • Statistical analysis plans and study-specific analyses developed with Clinical Data Management, including designs built on the Prostate Cancer Working Group endpoint criteria.
  • Reproducible data delivery and reporting pipelines, with rigorous dataset validation that scales across the portfolio.
  • Collaboration with the Biostatistics Service at Memorial Sloan Kettering Cancer Center on statistical modeling and analysis design.
05

Regulatory 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.

  • Multi-site start-up, coordinating what each site needs to open a study and receive investigational product.
  • Guidance and executable action plans that keep submissions aligned with evolving regulatory requirements.
  • Customized regulatory document packages and reliance on the PCCTC's central regulatory document repository to speed up site start-up.
06

Medical, 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.

  • Medical monitors review eligibility, safety, and dose decisions, with defined escalation pathways to sponsors and investigators.
  • Risk-based site monitoring plans tailored to each study, with regional monitoring partners outside the US working under PCCTC SOPs.
  • Centralized monitoring tracks trends in accrual, data entry, and query resolution across sites against expectations, including reviews for data quality timed to interim analyses and data monitoring committee meetings.
07

Correlative 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.

  • Established methods address pre-analytical, analytical, and post-analytical variables to validate assays for a CLIA environment per ICH and GLP guidelines.
  • CLIA-certified and CAP-accredited laboratory partners, from SOP development to specimen processing, storage, and tracking.
  • Computational biology and molecular pathology studies integrated into the clinical trials we manage.
08

Medical 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.

  • Protocols, informed consent forms, and study start-up presentations through abstracts, peer-reviewed manuscripts, and regulatory documentation.
  • An editor embedded with the project management team on each assignment.
  • Strict adherence to ICH, ICMJE, and project-specific guidelines for ethical publication and authorship.
09

Registries 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.

  • Registry design and operations across a network of more than 200 clinical research sites.
  • Nested substudies and retrospective data requests turn a registry into a research platform; five substudies have been built on IRONMAN to date.
  • Centralized data use agreements, controlled access to registry datasets, and PCCTC-supported data analysis streamline the completion and publication of research questions.
10

Quality Management

A dedicated quality function maintains the SOPs, study-specific plans, and oversight that keep every PCCTC-managed study inspection-ready.

  • Standard Operating Procedures covering budgeting and contracting, protocol development, quality management, correlative management, study and site management, safety monitoring, data management, and statistics and programming.
  • Study-specific operational plans for project management, statistical analysis, data management, monitoring, eTMF, cohort management, and communication, plus data monitoring and imaging/pathology committee charters.
  • Ongoing quality review of study conduct and documentation, with corrective and preventive action when issues are found.
11

Contracts and Budgets

Budgeting and contracting tools, built for multicenter research, speed activation and set consistent terms across institutions.

  • Template library that includes unilateral and bilateral confidentiality agreements, Clinical Trial Service Agreements and Full Service Provider Agreements, and Site Clinical Trial Agreements for trial-specific customization.
  • Rapid contracting with industry partners, efficient negotiation with clinical trial sites, and targeted advice on site agreement terms and expected site costs to offer swift, realistic negotiation timeframes.
  • A coordinated budgeting strategy aligned with project management, protocol development, and contracting, as well as an established Fair Market Value (FMV) objective benchmark used to price clinical trial services, investigator fees, and site procedures.
12

Advisory 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.

  • Advisory boards convene PCCTC investigators, including members of the Prostate Cancer Working Group (PCWG2 through PCWG4), on protocol design, endpoint selection, and patient population.
  • Clinical development strategy and study design consultation for programs at any stage.
  • Operational feasibility, project start-up, and site feasibility assessments ahead of a full engagement.

Let's advance your program

Talk with our team about study management, FSP support, or scientific collaboration.

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