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. 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.
A clinical oncology data management solution tailored to your needs.
PCCTC offers Caisis, a web-based clinical oncology data management system fully integrating research with patient care. For over a decade, collaboration with over 25 institutions has allowed Caisis to develop and evolve in an environment of constant feedback and scrutiny. Accordingly, Caisis’ clinical trial management and electronic data capture tools can be customized to fit the scale and complexity of each new project.
Our commitment to quality assurance.
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 lead site. Based on the Data and Safety Monitoring Plan, we create a Data Auditing Plan which describes compliance review, sample size, critical and non-critical data fields to be audited, frequency of audits, 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.