Statistical Consulting Service
 

Key benefits

  • High-quality deliverables, such as analysis ready datasets or full statistical analysis by our team of statisticians
  • Minimized time to final study report, from database lock to statistical output, enabled by our comprehensive analysis planning and development of early stage reporting programs
  • Global SOPs delivering consistency throughout your trials
  • Independent quality validation of formal deliverables to verify accuracy and audit readiness
  • Senior review of all deliverables, from protocol writing through regulatory submissions

Client-Focused Teams

Our teams are focused on sponsor needs, timelines and client-specific analysis standards. We have the flexibility to support aggressive timelines, project priorities and various business models and work closely with the client, facilitating collaborative, proactive communication.

 

Expert Statistical Scientists

Pharstat’s biostatistics team has a broad range of therapeutic experience, and statisticians hold advanced degrees. All of our statisticians and statistical programmers receive ongoing, intensive training that incorporates:

  • Industry information such as 21 CFR Part 11
  • GCP and ICH standards
  • SAS® software programming skills
  • Statistical methodology

Team members are also current with industry standards and market trends, such as Clinical Data Interchange Standards Consortium (CDISC) models.

 

Achieve Milestones on Time

Pharstat can help client define the right component of a study to optimize efficiency and help ensure the clinical results will meet trial goals----right from the start. We provide consulting services on development of comprehensive clinical development plans and protocols.

 

Quality Data to Support Development Needs

Pharstat can analyze specialty data to evaluate clinical benefit versus the cost of your therapy. We offer:

  • Mid-study evaluations including interim analysis.
  • Pharmacoeconomic and quality of life analysis
  • PK and PKPD analysis

 

Reduce Time & Cost of Drug Development

Pharstat can identify statistics and programming solutions that improve efficiencies in one study or across multiple studies. We offer:

  • Flexible solutions that integrate with customer systems and processes
  • Statistical analysis plans
  • Generation of randomization codes
  • Design and analysis of integrated summaries for safety and efficacy
  • Production of tables, figures and listings
  • Continuing scientific collaboration on ad hoc analyses, regulatory interactions, applications and annual safety reports
  • Statistical and clinical study reports
  • Preparation of regulatory submission data and documentations e-CRT/ CDISC
  • PK and PKPD analysis
  • Publication and abstract support

 

Deliver Submissions Sooner

Pharstat can harmonize data from multiple studies to facilitate ease of submission. We:

  • Pool multiple studies for submissions----harmonized to include individual and integrated reports
  • Build, implement and feed comprehensive data warehouses based on customers' needs and expectations.

 

Data Safety Monitoring Boards (DSMBs): Protect Patient Safety

Pharstat could help client continuously assesses the safety profile of investigational products. Our extensive experience with DMC/DSMBs in both the U.S. and worldwide includes studies in a broad base of therapeutic indications. Our assistance includes:

  • Set-up
  • Charter and analysis plan development and maintenance
  • Generation and distribution of data displays and reports
  • Meeting co-ordination and attendance
 
 
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