Services

By: The Counter-terrorism Professionals Network  09-12-2011
Keywords: Computer Systems, Due Diligence, Computer Systems Validation

Services

Using PharmaProSource® results in considerable cost savings because we give you the flexibility to choose only the services you need. Our flexibility and agility are unmatched by large CROs. 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.  It’s your call.

When you need SAS® programmers, you save even more when your team is augmented using our off-site resources who have their own copy of SAS for program development.  Using this model, your in-house staff directly manages your projects while using our contract resources for the routine programming.  We use your SOPs, specifications, naming conventions and programming style guidelines to develop SAS programs on our PCs with our version of SAS (9.1.3 or 9.2) in our offices. Your in-house team only needs to execute the final production programs.

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. Or you may need an experienced IT professional to perform due diligence on an emerging technology. PharmaProSourceprovides these resources.

When you work with PharmaProSource, you select the services you need based on your project requirements. PharmaProSource draws on a broad resource base that is structured specifically to provide value without adding expensive layers of management. Our low overhead means significantly lower rates for you—in many cases you save up to 50% when compared to conventional CRO rates.

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Keywords: Computer Systems, Computer Systems Validation, Due Diligence,

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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.


09-12-2011

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.


09-12-2011

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.


09-12-2011

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

Biostatistics

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. 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.