Services

The trusted IRO for prostate cancer research

The PCCTC supports both full-service study management and functional service provider (FSP) project support. Our comprehensive suite of industry-grade services, global consortium engagement, and world-class scientific expertise streamline and accelerate the activation, accrual, and completion of multicenter clinical studies.

Project Management

From concept to close-out, the PCCTC's Clinical Operations team ensures studies are completed on time and on budget, facilitating efficient, transparent study management between industry partners, investigators and participating sites, and external vendors.

Strategic selection of regional and international partners and participating sites, tailored to your unique study population.
Personalized sponsor- and study-specific management plans ensure seamless collaboration.
Clear, comprehensive, and technically feasible timelines ensure critical milestones are met.

Advisory Board

PCCTC Advisory Boards are composed of the nation's leading prostate cancer investigators. Effective development of new therapies draws on their expertise in drug development and their unique insights into the prostate cancer scientific landscape.

Investigators from PCCTC clinical research sites serve as advisory board members and are committed to the success of new programs.
Advisory boards enhance significant aspects of drug development including protocol design, endpoint selection, and patient population.
As members of the Prostate Cancer Working Group (PCWG2, PCWG3, PCWG4), board members outlined principles for trial conduct in progressive disease to bring clinical research more in line with clinical practice.

Contracts and Budgets

The PCCTC offers a suite of budgeting and contracting tools to expedite study activation. Our contract templates let us negotiate consistent terms of confidentiality, data ownership, publication, and intellectual property across institutions and industry.

Contract and budgeting tools include unilateral and bilateral Confidentiality Disclosure Agreements and a Master Clinical Trial Agreement for Industry Sponsored Clinical Research.
The PCCTC negotiates rapidly to contract with industry partners for clinical research activities to be carried out by the PCCTC.
A comprehensive budgeting strategy improves procedures for project management, protocol development, and contracting.

Regulatory

Proper management of regulatory affairs can dramatically shorten the time it takes to bring safe and effective products to market. The PCCTC coordinates the intricate details of regulatory document management throughout a project's lifecycle, serving as a single point of contact for industry partners and investigators.

The PCCTC specializes in multi-site start-up, coordinating the requirements for sites to open studies and receive investigational products.
Rapid regulatory expertise, guidance, and executable action plans ensure submissions meet evolving regulatory requirements throughout a study's lifecycle.
Efficient, customized packages of regulatory documents facilitate site start-up activities.

Medical Communications

The PCCTC offers numerous value-added medical communications services throughout a project's lifecycle. Dedicated staff collaborate directly with investigators, industry partners, regulatory agencies, and publishers to ensure rapid and reliable content production.

Comprehensive editorial services span protocols, informed consent forms, and study start-up presentations through to abstracts, peer-reviewed manuscripts, and regulatory documentation.
PCCTC editors with prostate cancer expertise work closely with project management teams on each assignment.
In its commitment to ethical publication and appropriate authorship, the PCCTC strictly adheres to ICH, ICMJE, and project-specific guidelines.

Clinical Data Management

A modern, standards-driven approach to data management delivers the secure, high-quality, rapid results today's prostate cancer trials require. Our workflows follow Good Clinical Data Management Practices and the latest FDA, ICH GCP, and GDPR requirements, leveraging Medidata Rave (EDC) and reusable CDISC-conformant libraries.

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 (IDRP) embeds cross-functional review — biostatistics, data science, clinical operations — at every milestone.
Encrypted portals and APIs give investigators real-time access and partner sharing while safeguarding institutional and sponsor IP.

Statistical Programming and Analysis

PCCTC biostatisticians and statistical programmers are involved at every stage of study planning and execution — from protocol and statistical analysis plans and data collection design through ongoing data-quality monitoring and reporting checkpoints — combining modern computing practices with strict GxP compliance.

Statisticians work directly with Clinical Data Management to optimize study-specific statistical analysis plans that generate quality, informative data and meet critical milestones.
PCCTC investigators are at the forefront of novel study design and national efforts around prostate cancer endpoints.
Disease-specific expertise in multicenter, hypothesis-driven trials and biomarker validation ensures studies efficiently measure meaningful endpoints.

Correlative Science and Laboratory Services

Accurate, reliable, reproducible lab results are essential for patient monitoring, regulatory approvals, reimbursement, and drug discovery. Driven by cutting-edge research at our contracted academic medical centers and biopharmaceutical partners, our capabilities meet the rigorous demands of today's drug development.

Established methodologies systematically address pre-analytical, analytical, and post-analytical variables to validate assays for a CLIA environment per ICH and GLP guidelines.
We work with CLIA-certified and CAP-accredited laboratories offering the full range of consulting and analytical services, from SOP development to specimen processing, storage, and tracking.
We specialize in integrating dynamic laboratory studies, including computational biology and molecular pathology, into the clinical studies we manage.

Data Science

In close collaboration with PCCTC Data Management and the Biostatistics Service at Memorial Sloan Kettering Cancer Center, our Data Science team applies programming best practices within a modern technology stack to streamline, scale, and enhance the reproducibility of the consortium's analytics and reporting pipelines.

Development and design of statistical models and analysis plans.
Custom data delivery and reporting pipelines built for reproducibility.
Rigorous analysis and validation of datasets, with scalable solutions to fit the needs of all stakeholders.

Let's advance your program

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