We offer our clients a comprehensive range of services. Following is a selection of some of the many services we provide to our clients’ projects:
- Clinical Trial Management – Selected and overseen by our Director of Clinical Operations, our Clinical Study Managers (CSM) serve as the main point of contact for our clients. Each of these individuals brings years of industry knowledge and experience to the client study team.
- Field Monitoring/Clinical Research Associates - realizing that each study is unique and requires an individualized clinical monitoring plan, we use a hybrid approach of therapeutic alignment and regionally based Clinical Research Associates (CRAs) to build the best monitoring team for each study.
- Clinical and Regulatory Staffing – We hire only experienced, seasoned monitors who are trained on the protocol, standard operating procedures, applicable FDA guidelines and Good Clinical Practice.
- Protocol Development – Our highly esteemed Director of Clinical Development is active in all aspects of study trial protocol design, site and patient recruitment and sponsor communication.
- Medical Monitoring – The medical monitor provides support to sites by addressing Investigator questions regarding appropriate interpretation/application of the study protocol and advising regarding appropriate medical management of subject emergencies.
- Biostatistics – Our nimble statistical team can be with the client during every step of the development process to make sure the biostatistical aspects of every study are the most efficient and robust possible.
- Clinical Data Management – We offer a full range of services to meet your data processing, analysis and project management needs. C3 Research Associates will provide high-quality and comprehensive data management support that is tailored to best suit your project. Our wide-range of experience in data management and quality assurance procedures along with our knowledge of FDA regulatory requirements will insure that your data will be accurate and your project completed on time and within budget.
- Regulatory Compliance – Our team provides every project with an individualized project feasibility evaluation, followed by personal guidance in designing and conducting a clinical trial. We work with you to plan, prepare and complete all of your regulatory submissions and then act as your liaison in all interactions with regulatory agencies.
- Quality Assurance – We provide high-quality and comprehensive data management support tailored to your particular project. This includes reviews of standard programs (GCPs, Validation, and 21 CFR Part 11 compliance), pre-audit readiness resources and audit participation and handling, compliance and quality assurance management, and audits of sponsors, clinical sites, vendors and service providers.
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More services provided by C3 Research Associates:
- Providing clinical development plans and protocol design input
- Training staff and investigators
- Serving as medical director to Sponsors without medical staff
- 24/7 Medical Monitor coverage
- Enhancement of regulatory compliance
- Clarifying inclusion/exclusion criteria with the investigator
- Providing consultation for potential safety issues or medical concerns regarding the clinical study
- Medical review of serious adverse events
- Providing medical review of C3 Research Associates deliverables such as final narratives or Clinical Study Reports
- Organizing Investigator Meetings
- Study design, including sample size determination and power calculation
Generation of randomization
- Protocol development, including generation of Statistical Section in Protocol
- Input regarding Efficacy and Safety endpoints
- Determination of most efficient methods of statistical analysis
- Determination of primary and secondary outcomes
- Generation of Statistical Analysis Plan including mock tables, listings and figures
- Generation of interim reports, including patient profiles
- Generation of Final Statistical Report, including programming for all report elements
- Review of Clinical Study Report
- Statistical representation for all Regulatory interactions
- Case Report Form (CRF) design
- Generation of CRF completion guidelines
- Data capture using either paper-based or Electronic Data Capture (EDC)
- Development of data management plans
- Development of data transfer specifications
- Generation of edit check specifications
- Development of clinical database specifications looking for consistency across studies
- and compliance with CDISC standards
- MedDRA and WHODrug coding
- Clinical Monitoring
- Protocol Design
- Site Selection
- Clinical Study Management
- Site Identification and feasibility
- Medical Writing
- Vendor Management
- Drug Safety Management
- Regulatory Services
- Assist and guide in designing and conducting a clinical trial
- Project feasibility evaluation
- Regulatory authorities Liaison
- Document preparation and submission, e.g., Investigational New Drug, New Drug Application, Abbreviated New Drug Application, Common Technical Document, Investigational Device Exemption/Premarket Approval
Quality Assurance Services
- Standard Programs (GCPs, Validation, and 21 CFR Part 11 compliance) review
- Pre-Audit Readiness Resources
- Audit Participation and Handling
- Compliance and Quality Assurance Management and Audits: Sponsor, Clinical Site, Vendor/• Service Provider
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