CLINICAL TRIALS MANAGEMENT AND DATA COORDINATING

CENTER

Extensive industry and government experience that guides clinical studies from inception to close-out

From protocol design and development to site management, data analysis, and report writing, CCSA scientific and technical staff work side by side with clients to chaperone trials to approval. Working closely with the study site, we train staff and assist with IRB approvals, subject recruitment, managing quality electronic study data, maintaining study documents, and successfully closing studies. We assist study sponsors with regulatory filing, meeting planning, study reports, and bringing products to market. We designed and filed the first successful Master IND in the history of the US with the FDA in 2009, for the innovative adaptive breast cancer study, I-SPY 2 TRIAL, and recently expanded it to the I-SPY COVID Trial in the worldwide fight against the COVID-19 pandemic. CCSA reaches goals—on target and on budget. CCSA’s certified regulatory affairs professionals (RACs) and clinical research associates (CCRAs, CCRPs), experienced project managers, and data managers assist in every step from initial data collection to published results and regulatory approval.

Study start-up and planning
Rapid start-up for all phases of clinical studies:

  • Project team identification and management
  • Site identification, qualification, and selection
  • Investigator recruitment
  • Investigator agreement/payment
  • Study supply management
  • Central laboratory management
  • Meeting planning and logistical support
Study documents
Study-specific, customized document management and coordination:

  • Protocol design and maintenance
  • Statistical Analysis Plans (SAPs)
  • Manual of Operations (MOP) preparation and maintenance
  • eCRF design and development
  • eCRF completion guidelines
  • Investigational drug logs and tracking
  • Deviation management
  • IRB/Independent Ethics Committee document generation, submission, and tracking
  • Safety reporting coordination
  • Query resolution coordination
  • Monitoring plan development and maintenance
Study personnel
Study-specific procedures provided through:

  • Remote investigator and initiation meetings including planning and organization
  • Remote or on-site training
  • Investigator/patient retention strategies
  • Facilitation and maintenance of site communications
Site visits
On-site and remote monitoring and coordination to ensure timely, quality data collection:

  • On-site and remote survey contacts and qualifications
  • Client-customized/risk-based on-site and remote routine monitoring (pre-study, initiation/activation, interim, closeout)
  • GCP/ICH/NIH/OHRP/HIPAA/FDA Common Rule compliance
  • Query and discrepancy resolution
Quality assurance and compliance
Unmatched grasp of regulations, practices, and tools for ensuring data quality:

  • Protocol and medical monitoring
  • Design and implementation of Quality Management Plans
  • Preparing clients for regulatory inspections
  • Providing comprehensive knowledge of FDA regulations
  • In-depth audit program check systems, investigational sites, and documents for GLP/ICH/GCP compliance
  • Creating client-specific audit plans to address each audit goal
  • CCSA prepares reports at the conclusion of each audit, providing detailed observations and required corrective action
Auditing services
Detail-oriented Quality Assurance experts for every need:

  • Prepare and maintain audit plans
  • Provide nonclinical, clinical, and regulatory audits, in compliance with FDA/ICH/GCP/OHRP/HIPAA
  • Create corrective action plans and follow-ups
  • Provide site staff training and education
  • Perform site and study audits
  • Site qualification
  • Data system audits
  • Study data audits
  • SOP and compliance audits
  • CRO audits