Multicenter clinical trials management. The PCCTC has created a new paradigm in collaborative drug development, fostering a culture of transparent project co-development through its unique infrastructure and committed team of research professionals. Our comprehensive suite of contract research organization (CRO) services and world-class scientific expertise streamline and accelerate the activation, accrual and completion of multicenter clinical trials.
Services
Project Management
The PCCTC successfully streamlines the clinical trial process through its innovative project management solutions. From concept to close-out, our experienced project managers ensure efficient and transparent co-development between investigators, research sites and industry partners.
Our unique suite of project management services accelerates development.
- Clear, comprehensive, and technically feasible timelines ensure critical milestones are met.
- Global communication plans keep stakeholders informed throughout a project’s entire lifecycle.
- Real-time monitoring and tracking of expenditures and deliveries allows for timely resolution of budget discrepancies.
- Our team provides personalized project- and study-specific training focused on accuracy and compliance.
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 & Budgets
The PCCTC offers a suite of budgeting and contracting tools to expedite trial 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 trials and receive investigational products.
- Rapid regulatory expertise, guidance, and executable action plans ensure submissions and activities throughout the lifecycle of a clinical trial 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 Writing
The PCCTC offers numerous value-added medical writing 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 dynamic approach to data management addresses the critical need for secure, high quality, and faster, more efficient clinical trials and adheres to Good Clinical Data Management Practices (GCDMP) and applicable regulations and oversight agencies. Our powerful clinical trial and EDC technology, and rigorous standard operating procedures, combined with our comprehensive data support services and extensive oncology knowledgebase, enable us to tailor scalable solutions to fit the needs of both investigators and industry partners of any phase and type of oncology study.
PCCTC data management tools and services have been developed to meet the demands of the next generation of data-driven clinical trials.
- Our integrated advanced technologies and infrastructure enable us to enforce standards across studies with reusable libraries, dictionaries, templates, tools and processes.
- Providing investigators with access to and the ability to exchange data with multiple partners while protecting the intellectual property of each institution and sponsor.
- Our processes and meticulous Data Management Plans (DMP) describe data management processes from study start-up to closeout, adhering to Good Clinical Data Management Practices and applicable regulations and oversight agencies.
- The PCCTC’s highly skilled data management team offers EDC training, continued technical and clinical support, and frequent follow-up to establish efficient data practices at participating sites.
Transparency via Data Management Plan
The PCCTC prepares comprehensive Data Management Plans (DMP) that serve as a road map in collaboration with all stakeholders to describe project timeline, roles and responsibilities, EDC technology and security measures, data management processes and tasks from study start-up to closeout including coding, cleaning, reconciliation, data transfers, quality assurance, metrics and reports
Rigorous eCRF Design and Validation
We meticulously review the study protocol to ensure accurate, consistent, efficient and logical data collection and eCRF design conforming to CDISC CDASH standards. We methodically validate database and study-specific components to ensure integrity.
Powerful EDC Technology and Support
The PCCTC uses Medidata Rave, a powerful web-based system and simple platform that combines EDC and advanced clinical data management capabilities. The PCCTC’s highly skilled data management team offers EDC training, continued technical and clinical support, and frequent follow-up to establish efficient data practices across participating sites.
Our Commitment to Quality Assurance
Our highly skilled Data Management team specifies, programs, and validates automatic edit checks, system alerts, custom functions, conducts frequent and thorough data reviews, and generates data quality reports measuring error rate.
The PCCTC provides essential infrastructure and procedures necessary for ensuring quality assurance, quality control, and study monitoring. All projects in which data are managed by the PCCTC follow a Data and Safety Monitoring Plan either developed internally or provided by the sponsor which describes compliance review, sample size, critical and non-critical data fields to be verified, frequency of monitoring visits, tentative site visit schedule, corrective action, and any other relevant information for each clinical trial. Throughout, our commitment to FDA (21 CFR 312) and applicable GCP, ICH, ISO, and institutional regulations is paramount.
Statistical Analysis
Biostatistics is involved in all stages of PCCTC clinical trial planning fromdata collection and analysis to final evaluation. A PCCTC statistician provides crucial input on the design and analysis of clinical trials, randomization procedures, and the increasingly more complex task of interpreting results.
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 trial 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
& Laboratorial 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 in to the clinical trials we manage.