CR2O
CR2O
Dekking Consultancy works together with CR2O, in the field of clinical operations.
CR2O is a clinical operations partner for every service and challenge during your clinical trial lifecycle. CR2O’s network of internationally recognized academic leaders contributes to the design, conduct and interpretation of clinical trials in the field of immunology and vaccinology.
Services offered:
- Clinical Trial Management
- Global project management
- Clinical development plan
- Development of trial synopsis, protocol, and study report
- Study feasibility and site selection
- Clinical operations plans and manuals, e.g. Project plans, Communication plans, Operational plans and Monitoring plans
- Clinical monitoring
- Regulatory Strategy & Affairs
- Target product profile development
- Development, reviewing, and approving all clinical documentation required to start a clinical trial
- Preparation of regulatory scientific consultations
- Perform regulatory submissions at the competent authority / ethics committees
- Collection and check for completeness of regulatory and EC documents
- Obtaining approval for clinical trial in each of the participating centers
- Grant Proposal Development
- Grant proposal development
- Scientific program management
- Financial program management
- Data Management & Biostatistics
- Development of data management plan
- eCRF design and setup
- Development of data validation plan
- User acceptance testing of eCRF and validation checks
- eCRF training for users
- Integration of electronic data from central lab in the eCRF
- Continuous data review (including query management)
- Coding of medical terminology e.g. Adverse events, medical history, medications
- Serious adverse event reconciliation between eCRF and safety database
- Database lock and data exports
- Development of statistical analysis plan
- Development of randomization listings
- Perform power calculation and provide statistical input on the protocol
- Development, validation, and documentation of SAS programs
- Development of specifications for analysis datasets e.g. Tables, listing, figures
- CDISC/ADAM conversion
- Generation of statistical reports
- Pharmacovigilance & Medical Monitoring
- Global drug safety project management
- Eudravigilance setup and management
- Collection and follow-up of serious adverse events (SAEs) from clinical trials
- Electronic management of SAEs on the safety database
- Expedited reporting to competent authorities
- Expedited reporting to ethics committees and investigator sites
- Six-monthly and quarterly reporting to competent authorities and ethics committees
- Responsible person for Eudravigilance oversight
- Reconciliation with clinical database
- Compliance review and oversight
- Signal detection
- Preparation and distribution of DSURs
- Medical oversight of clinical trials
- Setup of DSMB
- Management of DSMB
- Coding of medical terminology
- Insourcing
- Trained life science professionals
- Individuals or teams
- Flexible contract durations
- Flexible staffing models
- Flexible staff locations
- Diverse backgrounds and expertise
- Quality Management & Auditing
- Quality Management System (QMS) Designed to meet the requirements of the international standard ICH E6 (R2) Guideline of Good Clinical Practice (GCP), based on the principles of ISO 9001:2015
- Training and advice e.g. On ICH E6 GCP guidelines and GCP-related laws and regulations
- Quality review of all clinical documentation required to start a clinical trial
- Support and advice on the development of your GCP-based QMS
- Vendor assessment
- GDPR compliance
- Audits of Investigators / Sites
- Audits of Vendors (GCP, GLP and GMP)
- Internal system audits
- Medical & Scientific Writing
- esearch Protocols
- Investigator's Brochures
- Investigational Medicinal Product Dossiers
- Clinical Study Reports
- Scientific Publications