Pharma and Health Care IT Services

More than 80,000 clinical trials alone are conducted in the United States per year and about 95% of them are still paper-based. So it is not surprising that as life sciences organizations seek ways to drive efficiency and improve performance, one of the areas most closely scrutinized is the clinical development process. Although technological developments have enabled life sciences organizations to gather, process, and communicate clinical trial information more quickly, most of the information technology investments have been in point solutions, applications that address requirements to a particular point in the process. In other words, companies have simply adapted their existing systems to meet the new challenges rather than revising the clinical process as a whole. As a result, some organizations may have between 25 and 30 software applications requiring integration, support, and maintenance.

Data collection and management currently account for up to 60% of the overall clinical trial process, a timeline that drug companies increasingly find unacceptable as they face increasing pressure to test, approve, and market new drugs faster than ever before. Introducing an integrated content management solution to automate the documentation process relevant to clinical trials and related activities can help cut the time for these trials by two-thirds.

The use of electronic data interchange and the internet as an effective and secure mechanism for data transportations, information sharing, and collaboration have been achieved across number of critical financial and manufacturing sectors with a velocity that suggests it safe for the clinical trial entities to move aggressively, effectively and more forcefully.

Clinical trial operations management has relied on an inefficient combination of manual paper-based procedures and a variety of non-descriptive and in-house developed software applications. Typically, software applications were implemented as self-contained, point solutions with little in the way of design considerations for integration with other applications or business processes that are traversed functional areas. More generic product means more competition in off patent market. More competition in off-patent market means more low-price products. More low-price products in off-patent market mean more resources for innovative products. More innovative products to be generated mean early identification for candidate for drug research.

Therefore the issues mentioned above puts a great importance for quick turnaround of the studies, to prudently use the financial and human resources without repeating to do the same things again and again.

What does PWC do in Clinical Trails?

PWC is the leading provider of market research and Clinical trial services. We specialize in connecting pharmaceutical business to target market research by utilizing our extensive expertise. Regardless of the size of your company, PWC can assist you in combining in-depth domain expertise, sophisticated analytics and world-class technology to deliver measurable and actionable results that significantly improve the performance of brand portfolios and pharmaceutical sales forces. We offer best in class practices in Clinical trial design, implementation, analysis, reporting, data management and statistical analysis.

PWC Clinical Trials streamlines the clinical trial process by capturing, authoring, processing, and managing clinical documentation. By standardizing, controlling, and securing clinical trials-related content, PWC Clinical Trials reduces the costs of data acquisition and clean up during trials, enables real-time decision-making based on immediately accessible data, and ensures regulatory compliance and faster submission preparation.

PWC Inc is dedicated to creating innovative Software Solutions and Services for companies in the clinical research: Pharmaceutical, Biotechnology, Contract Research Organizations and Medical Device companies. PWC specializes in Software and Services in biostatistics, validation with compliance to CDISC and CFR Part 11, clinical data management, medical writing, and project management. PWC software tools, therefore, tremendously reduce the time for pharmaceutical and biotech companies in preparing their submissions to the FDA.

PWC has consulted to many pharmaceuticals, biotechnology and CRO companies, contributing to its in-depth understanding of the intricacies of clinical data. This knowledge is pivotal to the understanding of how data is captured within a data management system and transformed in a data warehouse before being distilled into an electronic submission. All of PWC software tools were developed from this industry experience to deliver systems that are easy to use and optimize workflow.

Clients: Many progressive and innovative companies, including Merck, Sanofi Aventis, Amgen, Chiron, Genentech, Allergan, Genzyme, Astrazeneca, Icon, and Novartis & Quintiles have been PWC clients. They span a diverse group of biotechnology, pharmaceuticals and Clinical Research Organizations.

Expertise in quality services

PWC has a highly skilled and experienced team providing clients with support from phase 1 through the regulatory submission process. We have expertise in statistical programming, biostatistics, data management, medical writing and project management. Our own software can accompany our services or we can develop customized solutions based upon the client's requirements.

Standards and CFR Part 11 Compliance

• Perform Systems Validation
• CDISC Compliance and Data Integrity Service
• Write SOP and Guidelines
• Prepare Electronic Submission Documentation (define.pdf)

SAS Programming

• Tables, Listings and Graphs
• Analysis Datasets
• Validation of SAS Programs
• Patient Profiles and CRF Tabulations

Biostatistics

• Develop Statistical Analysis Plans
• Statistical Review of Tables, Listings and Graphs
• Produce Statistical Reports
• Represent Client at FDA Meetings
• Write Statistical Methods for Protocols
• Plan and Develop Protocols
• Design and Develop Clinical Plans

Medical Writing

• Write Study Reports
• Prepare NDAs
• Produce Protocols
• Generate Manuscripts
• Provide IND Updates
• Write SOPs

Project Management

• Manage the CRO Process
• Manage Budget, Timelines, and Deliverables
• Produce RFP and Review Bids

Data Management

• Design Case Report Forms
• Design Custom Databases
• Perform Data Entry
• Manage Discrepancies
• Provide Electronic Case Report Form Review
• Generate Monitoring and Status Reports

CRM Siebel Life sciences

• eClinical implementations
• ePharma and eMedical application services