CPC Clinical Research: Our Services

Biostatistics

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.

Our biostatistician's collaborate with sponsors to develop comprehensive, well defined, ICH compliant, statistical analysis plans including:


  • Testable and scientifically relevant hypothesis
  • Clearly stated sample size justification and powering assumptions
  • Statistical conventions and analysis of definitions
  • Comprehensive description of the statistical methodology
  • Mock tables, listings and figures

Our biostatisticians bring industry and academic experience, in a wide array of therapeutic areas, to your project.


  • Clinical or product development plans
  • Protocol and case report form development
  • Statistical analysis plans and statistical programming
  • Randomization schedules and treatment allocation plans
  • Collaboration on reporting needs (ad hoc analysis, application support and safety reporting)
  • Interim and final analyses
  • Statistical support throughout your trial or clinical development
  • Statistical interpretation and reporting for study reports, manuscripts and presentations
  • Data integrations
  • Independent Committee support and reporting (data monitoring, steering and adjudication committees)
  • Clinical Data Acquisition Standards Harmonization (CDASH) Services (CDISC/SDTM/ADAM)

Data Management

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.

Data Management Services Include:

EDC/eCRF design and management

Data edit specification, validation and query resolution

Data tracking, entry and verification

Data integrity and reconciliation with external data sources

Adverse event and concomitant medication coding

Global Project Management

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:

Project planning, establishment of timelines and milestones

Project tracking, including full periodic reports detailing progress against baseline

Proactive mitigation of risk quality, timelines, deliverables, and costs

Regular project team meetings with agendas and minutes with a particular focus on action items to ensure progress on the right activities

Development of study specific materials

Investigator meeting coordination, presentation and training

Site and vendor contract and budget negotiation

Management and coordination of site training and monitoring for quality of primary and secondary endpoints

Identification of potential investigators, study site selection

Assisting sites with developing successful recruitment strategies

Oversight of site regulatory documents

Medical Affairs and Pharmacovigilance

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).

Therapeutic Expertise:

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.

SMA Development Services:


  • Protocols
  • IND/IDE submissions
  • Investigator brochures
  • Clinical study reports
  • Manuscripts, abstracts, posters and oral presentations

Medical Monitoring Services:


  • Regulatory reporting
  • Adverse Event
  • Serious Adverse Event
  • Unanticipated Adverse Reaction

Committee Management, Formation and Participation Services:


  • Clinical Endpoint/Adjudication Committees
  • Independent Data Monitoring Committees
  • Executive/Steering Committees
  • Entry Review Committees

Site Monitoring Services


  • Site selection, Site Initiation, Routine Monitoring and close out visits
  • Ensure all Serious Adverse Events (SAE) are reported according to all applicable regulations
  • Evaluate and assist site with adherence to all applicable regulations and guidelines (e.g., GCP, FDA)
  • Verification of proper receipt, dispensation and storage of study drug
  • Monitor inclusion and exclusion criteria, primary efficacy and all other study data
  • Ensure that the data are correct, complete, and supported by source documentation

  • Ensure Informed Consent compliance
  • Review and ensure all site regulatory documents are current
  • Identify problems associated with study site(s)
  • Assist sites with query resolution
  • Written reports to documents visits, site deficiencies and site activity

Regulatory Affairs and Quality Assurance:


  • Regulatory Affairs
  • Quality Assurance Consulting
  • Vendor and Investigative Site Audits

CPC Clinical Research distinguishes itself from other full service, for-profit CROs with ourEndpoint Quality Intervention Program ( EQuIP®):

Controlled data variability results in smaller sample size and lower development costs.

Conclusive results for Sponsors to make clear development decisions.

Reduced placebo response & data variability.