Services

Clinical Development Plans – the basis of any successful program is a well structured and thought out clinical development plan.  PNWStat brings to you a team with the experience and expertise to assist you in formulating a plan that can evolve and expand as your knowledge and experience with the product increases.  Our focus is on helping you determine the following key parts of a development plan: Number and Kind of Trials Required Use of Noninferiority and Superiority Trials Decision Analysis Support (i.e., probability of success) Development of Labeling Strategy Study Design – successful execution of the development plan requires insuring that the required trials are well designed to answer the important and relevant questions.  The following categories cover the broad areas we have found are key to designing successful clinical trials.   Protocols Trial Design (e.g., stratification and randomization techniques) Endpoint Selection Analysis Specification Sample Size Statistical Analysis Plan Statistical Analysis Methods Adjustments Missing Data Strategies Table, Figure and Listing Shells Data Safety and Monitoring Committees – when a protocol requires independent monitoring, PNWStat can assist you.  We can provide the following services: Prepare committee charters Serve as Committee Statistician Prepare and Present Interim Analyses Provide programming support Statistical Programming for Clinical Study Reports (CSRs) – PNWStat programmers have extensive experience in providing the following to our clients.  On-time delivery of the required analyses and validated programs are our strong suit. Dataset Creation Compliant with CDISC Recommendations SDTM Files ADaM Files Validation of Derived Variables Programming of Planned Analyses Validation of Summary Tables, Figures and Listings Ad Hoc and Exploratory Analyses Statistical Support of Regulatory Activities – successful interaction with regulatory agencies is a cornerstone of any development project.  PNWStat brings international experience to the table to assist you with these activities. Briefing Document Preparation and Review Strategy Analyses Materials Filings Strategy Development Review of Filing Materials Responding to Regulatory Requests for Analyses Programming Support Development of Advisory Committee Presentations Labeling Strategy Meetings with Regulatory Agencies Preparation for Meetings Meeting Participation Response to Regulatory Comments Clinical Study Reports – clear, concise, and well-written study reports are vital to communicating the results of your studies to a variety of audiences.  PNWStat can help you with completing these essential tasks. Meeting and symposia abstracts, posters, and presentations Summarization of Findings Interpretation Report Preparation Outsourcing Activities – effective use of outsourcing can add value to any project.  PNWStat can assist you in determining when and how best to use a CRO in the completion of your project. Statement of Work Preparation Development of Statistical and Validation Requirements Review of Proposals CRO Activity Monitoring Process and Business Development – knowing when to bring expertise in-house and how to determine and allocate resources is a difficult challenge facing many companies.  PNWStat can help you with the following tasks that will guide you along the path to creating internal support for your product. Budgeting and Planning Data Processing Infrastructure Planning and Evaluation SOP Development