Biostatistics

By: The Counter-terrorism Professionals Network  09-12-2011

Biostatistics

Consistent, high quality reports are a top priority. We provide you the assurance that reports generated meet industry standards for quality and integrity. PharmaProSource® designs and writes statistical analysis plans, then performs interim, final, ISS and ISE analyses of the data.  We also provide statistical support (e.g., unblinded statistician) for Data Safety Monitoring Committees (DSMC/DSMB). Using state-of-the-art statistical analysis tools, we ensure that your data are accurately analyzed and presented in the format required for regulatory submissions.

Statistical Consulting Services Include:   

·   Study design and protocol development

·   Analysis dataset specification

·   Sample size determination

·   Statistical analysis plan development (including table/listing/graph/figure shells)

·   Statistical report writing

·   Statistical support for Advisory Committee meetings

·   Data monitoring committee support


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Other products and services from The Counter-terrorism Professionals Network

09-12-2011

Computer Systems Validation

Our expertise includes performing the initial risk assessment and drafting requirements specifications, then creating test plans for the installation qualification, operational qualification, and performance qualification. If you want to control the cost of software implementation and upgrade, ensure that test cases trace to elements of risk management, and increase your overall productivity, we will help.


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Information Technology

Services range from general IT infrastructure planning and implementation, evaluating a hosting facility and/or moving applications, to simple database administration. We also act as liaison between in-house clinical research and IT departments to help formulate best practices, and perform due diligence on emerging technologies. PharmaProSource® provides experienced senior level IT consulting services to help you reach your business objectives.


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Project Management

We have senior level staff who will manage the technical phases of a project, such as statistical plan creation, TLGF production, or system migration. You may have a full complement of SAS® programmers, but need a managing statistician or a senior SAS programmer to keep a project on track. PharmaProSource fills your technical project management gaps so your projects are completed on time and within budget requirements.


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SAS Programming

At PharmaProSource®, all statistical programs are subjected to a rigorous quality assurance process, all documents go through a thorough internal review prior to delivery, and all statistical outputs are independently programmed. We incorporate quality control checks throughout all stages of programming and analysis. Conversion of clinical study datasets to conform with CDISC SDTM standards.


09-12-2011

Services

You may opt for turnkey biostatistics and programming solutions in some cases, while in other situations, you may need ad-hoc computer systems validation for a system upgrade while your staff is busy working on another project. We use your SOPs, specifications, naming conventions and programming style guidelines to develop SAS programs on our PCs with our version of SAS in our offices.