CPC’s biostatistical team is involved upfront in the planning and design of the study. The involvement of the biostatistician through the entire study from the design, data collection and cleaning, analysis and reporting reduces risk, improves quality, shortens timelines and lowers costs.
The results of your trial depend on the quality and integrity of the data. CPC has data management expertise in all phases of clinical development (Phase I-IV) across a wide array of therapeutic areas. CPC has established standards and procedures that are flexible enough to meet your project needs while ensuring the highest quality of your data throughout the entire study.
At CPC we believe that effective multi-disciplinary teams are the best way to achieve the goals of any project. Project teams consist of representatives from each functional area (e.g., Biostatistics, Data Management, Monitoring, Medical Affairs, Pharmacovigilance, Regulatory Affairs) for the particular project. Project Managers oversee a project from inception to final deliverables.
Global Project management services may include:
Scientific and Medical Affairs (SMA) bridges the gap between academia and industry providing scientific and medical thought leadership to clinical development programs including endpoint selection, clinical study designs, trial conduct, clinical data interpretation, and regulatory submissions. Comprised of clinical research scientists, medical writers, medical safety officers and safety specialists the SMA team provides day-to-day medical and scientific oversight for Phase I-IV clinical trials.The SMA team also provides critical input into CPC’s endpoint quality assurance efforts, which focus upon reducing endpoint variability via the Endpoint Quality Intervention Program (EQuIP).
The SMA Department has a depth of clinical and clinical research experience in a wide array of therapeutic indications. As a direct affiliate of the University of Colorado, the SMA Department regularly draws upon field-leading expertise across the spectrum of indications, scientific fields, and medical subspecialties, leveraging the strength of the University of Colorado faculty for the benefit of drug/biologic/device development programs.