Services
The PCCTC is the trusted integrated research organization (IRO) for both full-service study management and functional service provider (FSP) project support. Having established a new paradigm in collaborative therapy and biomarker development, the PCCTC fosters a culture of transparent project co-development through its unique infrastructure and committed team of research professionals. Our comprehensive suite of industry-grade services, global clinical 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 and transparent study management between industry partners, investigators and participating sites, and external vendors.
Our unique suite of project management services accelerates development.
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 upon their expertise in drug development and the group’s unique insights into the prostate cancer scientific landscape.
Our unique suite of project management services accelerates development.
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 and PCWG3), PCCTC advisory 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 allow us to negotiate consistent terms of confidentiality, data ownership, publication, and intellectual property across institutions and industry.
The PCCTC ensures all stakeholders share responsibilities in development pathways, trial design, data evaluation, and decision-making
Contract and budgeting tools include unilateral and bilateral Confidentiality Disclosure Agreements, 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.
Our comprehensive budgeting strategy is designed to improve 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.
Centralized management of regulatory affairs means improved communications and abbreviated timelines.
The PCCTC specializes in multi-site start-up, coordinating the necessary requirements for sites to open studies and receive investigational products.
Rapid regulatory expertise, guidance, and executable action plans ensure submissions and activities throughout the lifecycle of a clinical study meet evolving regulatory requirements.
Efficient, customized packages of regulatory documents facilitate site start-up activities.
The PCCTC operates a finely tuned centralized regulatory management plan that facilitates seamless collaboration between investigators, research sites, industry partners, and regulatory agencies.
Medical Communications
The PCCTC offers numerous value-added medical communications services throughout a project’s lifecycle. Dedicated staff collaborates directly with investigators and industry partners – as well as regulatory agencies and publishers – to ensure rapid and reliable content production.
All aspects of drug development benefit from clear and accurate communication.
Comprehensive editorial services range from the development of protocols, informed consent forms and study start-up presentations to the generation of abstracts, peer-reviewed manuscripts and regulatory documentation.
To effectively carry out its medical writing services, PCCTC editors with prostate cancer expertise work closely with project management teams on each assignment
In its commitment to ethical considerations, rapid publication, and appropriate authorship and contributorship, the PCCTC strictly adheres to ICH, ICMJE, and project-specific guidelines.
Clinical Data Management
The PCCTC’s modern, standards-driven approach to data management delivers the secure, high-quality, and rapid results required for today’s prostate-cancer trials. Our workflows follow Good Clinical Data Management Practices (GCDMP) and the latest FDA, ICH GCP, and GDPR requirements. Leveraging powerful Medidata Rave (EDC) functionality and reusable CDISC-conformant libraries, we tailor scalable solutions for investigators and sponsors at every phase of development.
Our robust Integrated Data Review Process (IDRP) embeds cross-functional review—biostatistics, data science, clinical operations—at each milestone to ensure quality is engineered into every database build, not bolted on later. Centralized medical-dictionary management (MedDRA, WHO Drug, LOINC / SNOMED) and automated coding dashboards keep terminology accurate and submission-ready.
Standards-based CRF libraries aligned to CDISC CDASH and prospectively mapped to SDTM/ADaM
End-to-end compliance with 21 CFR Part 11, FDA Data Standards Catalog, and EU/UK GDPR
Inspection-ready DMP co-authored with sponsors outlines roles, IDRP checkpoints, edit-check strategy, coding standards, and QC metrics.
Encrypted portals and APIs give investigators real-time access and partner sharing while safeguarding institutional and sponsor IP.
On-demand EDC training, proactive technical guidance, and ongoing follow-up drive efficient, high-quality data practices.
Peer-reviewed eCRFs, shaped by industry lessons learned and best-practice collection strategies, with dynamic controls and automated edit checks ensure clean data at the point of entry.
MedDRA/WHO Drug coding (oncology-enhanced) plus dashboards that let medical monitors resolve discrepancies quickly.
Statistical Programming and Analysis
The PCCTC's Biostatisticians and Statisical Programmers are involved in all stages of PCCTC clinical study planning and execution, including development of protocol and statistical analysis plans, design of data collection, ongoing monitoring of data quality, and regular reporting checkpoints through study completion. This key function of the PCCTC's Data Science team combines modern computing practices with strict compliance to GxP standards.
Whether data collected in a clinical trial will have an impact on future patient care or not depends entirely on statistical design.
Our statisticians work directly with the Clinical Data Management team to optimize a study-specific statistical analysis plans (SAP) to generate quality, informative data and meet critical study milestones.
PCCTC investigators are at the forefront of novel study design and have been instrumental in national efforts around prostate cancer endpoints.
Disease-specific expertise in multicenter, hypothesis-driven clinical trials and biomarker validation ensures our studies efficiently measure meaningful prostate cancer endpoints.
Correlative Science and Laboratory Services
Accurate, reliable and reproducible lab results are an absolute necessity for patient monitoring, regulatory approvals, payer reimbursement and drug discovery. Driven by cutting edge research at our contracted academic medical centers and our biopharmaceutical partners, the PCCTC’s correlative science and laboratory capabilities meet the rigorous demands of today’s drug development challenges.
Correlative science provides essential evidence-based metrics and aids in the discovery of new therapies.
Foremost experts in correlative science, PCCTC investigators have established methodologies to systematically address the pre-analytical, analytical, and post-analytical variables to validate assays for use in a CLIA environment, and according to established ICH and GLP guidelines.
We work with CLIA certified and CAP accredited laboratories that offer a full range of consulting and analytical services including project management, SOP development, data integration, and specimen processing, storage, and tracking.
We specialize in integrating dynamic laboratory studies, including computational biology and molecular pathology techniques into the clinical studies we manage.
Data Science
Our Data Science team, in close collaboration with PCCTC Data Management and the Biostatistics Service at Memorial Sloan Kettering Cancer Center, participates in many long-range collaborative projects covering a broad spectrum of clinical research. This includes the development and design of statistical models and plans, custom data delivery and reporting pipelines, and rigorous analysis and validation of datasets.
The PCCTC’s modern approach to clinical data science paired with the team’s deep quantitative oncology expertise allows the PCCTC to tailor scalable solutions to fit the needs of all stakeholders.