Areas of Expertise
Our services cover all aspects of the patient journey, from initial assessments to tailored care plans and continued support. With advanced tools and a dedicated team, we ensure a streamlined experience for all involved.
SOP and Process Development
Our TMF Team of experts understand that your TMF needs to be complete, accurate, and inspection ready at all times. We can provide a foundation that includes clear and concise SOPs, work flows, and process instructions. These tools are developed with your Study Team to build a meaningful and customized solution that ensures the System of Record for all your content is complete and accurate.
TMF Reference Model Implementation
As Reference Model Experts, GCP Perfected specializes in indexing your organization’s documents within the TMF Reference Model. We are ready to complete a comprehensive Expected Document List that is developed through consultation with your team. This ‘table of contents’, will standardize expectations across the board.
Data Management
GCP Perfected supports a patient-centric approach and a comprehensive end-to-end technology solution. This solution integrates paperless trial capabilities with consolidated reporting across platforms, leveraging industry-leading software for EDC, IRT, eCOA/ePRO, eSource, eConsent, eReg, and Safety. By establishing single sources of truth, we ensure data integrity, as reports are only as reliable as the accuracy of the underlying data
Comprehensive Site Support
GCP's Clinical Research Coordinators (CRCs) manage every aspect of study visits, including block enrollment, on-site recruitment, patient record assessments, electronic medical record (EMR) reviews, and scheduling.
Inspection Readiness
GCP Perfected’s TMF experts have years of experience developing and conducting Mock TMF Inspections. This Powerful tool is compliance-based process that can evaluate your TMF story. GCP Perfected’s modifies this process to fit your organization’s goals. The result of this dynamic process is used to ensure a pristine System of Record, control regulatory risk, and create the highest expectations for your TMF
Document Quality Control
Medical monitoring for GCP Perfected-managed clinical trials is conducted by a team of specialized professionals, ensuring that adverse events, protocol deviations, and concomitant medications are reviewed by experts. Our team participates in meetings and provides tailored support and training as needed. All activities are guided by a mutually agreed-upon Medical Monitoring Plan, ensuring thorough oversight and efficient issue resolution.