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 phaseand 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.