Our principal consultants each have over 15 years of global pharmaceutical industry experience in clinical trials operations, biostatistics, data operations, regulatory compliance, and computer systems. This extensive experience allows META to offer expert and cost-effective services in these areas, as well as strategic planning and analysis, and process architecture design and implementation.

Strategic Planning and Analysis

Companies today are examining their core business areas in order to be more cost-effective and to improve their overall utilization of available resources. Often this is not done with a goal to reduce the number of clinical development projects, but rather to hold them at the same level or, in fact, to increase them using the same or fewer resources. And, of course, speed remains as important as quality. As a result, companies need solutions to manage their workload and time-dependent deliverables for success and quality.

META can assist clients to develop a specific business process strategy that will include a number of solutions to meet both core and support needs. Solutions provided to the client are based on unbiased expert opinion and may include, for example, the establishment of an in-house functional group, virtual staffing, and outsourcing in areas such as clinical trial operations, clinical data management, biostatistics, and regulatory document and submission management. Some of the business process strategies that META has extensive experience in developing and managing are:

• Clinical Data Management and Biostatistics Operations Development and Management
• Regulatory Submission and Preparation and Management
• Quality Assurance and Control Management
• Clinical Technology Evaluation, Development and Management

META’s Business Process Strategy services provide many benefits to the client. For example:

• An operational strategy that is technically sound and can be implemented
• Independent and unbiased expert advice
• Cost-effective Solutions for Today and a Strategy for Tomorrow

Clinical Systems and Data Architecture

META can assist its clients in evaluating clinical system needs, IT infrastructure, and organizational readiness for such systems as electronic data capture, clinical data management, knowledge management, adverse event reporting, statistical reporting, and document management. META can assist with the development of a strategic plan for the continual evaluation and recommendation of clinical systems, software, and technologies to support the business needs.

SOP Architecture Planning and Implementation

META has extensive experience in assisting clients in the design of an organizational strategy for the development and implementation of standard operating procedures (SOPs), work practice documents, standards, and operational templates that adhere to ICH guidelines, local regulations, and client corporate policy and standards. The META model for SOPs provides for the integration of standard procedures and processes across the functional areas rather than within each area. META can provide project management as well as subject-matter experts to assist the client in the preparation, implementation, and change-control aspects of the SOP architecture project.

Business Best Practices and Metrics Analysis

Internal and external drivers have challenged companies to decrease the time it takes to conduct clinical trials while maintaining or exceeding current quality standards. Companies are constantly striving to optimize their clinical trial processes from patient recruitment, data management and study analysis, and reporting to submission management. META staff members have published a number of articles on best practices and metrics in clinical research. With its expertise in the area, META can conduct a detailed assessment of the client’s systems, processes, and procedures. The assessment includes:

• A retrospective analysis and development of a predictive model in order to predict future costs and resource needs
• Identification of the key metrics that are meaningful within the organization
• Summary of the current and future cycle times and potential cost savings
• Identification of the critical quality checkpoints in the workflow
• Identification of specific opportunities for significant process and quality improvement
• The role of technology as an enabler

The Best Practice and Metrics report provides client-specific recommendations for incremental, but significant, improvements in workflow processes, procedures, and systems. The results generate a knowledge base which supports rapid improvements in processes and systems and provides a valuable benchmark on production, performance, quality, and cost metrics.

Representative Projects

• Clinical Data Management/Statistical System Validation
  We also validated an Oracle/SAS-based data management/statistical system for a large multinational pharmaceutical company. This project allowed us to participate in the proactive validation before this system was used at two sites (domestic and international). Testing scripts were written for testing internationally. Test scripts which were written internationally were executed domestically. We also trained users and we were responsible for the preparation of all Standard Operating Procedures that were used once the system became operational for the client.
• Clinical Data Management Operations Evaluation
  Performed a detailed evaluation of a clinical data management operation for a global pharmaceutical company. This evaluation covered the data management operations locally and overseas. The resultant report provided recommendations for meeting regulatory requirements of the FDA and the European Community regulatory bodies.
• Electronic Document Management System Implementation Consulting
  Developed a Project and Quality Management Plan for the global implementation of an electronic document management system. This plan provided an overview of all processes and deliverables pertaining to the domains of project management and quality management as they relate to the development and deployment of the system.
• HMO Quality Assurance Planning
  Developed a quality assurance plan for a Health Management Organization support organization to assist the deployment of new products and services to its clients.
• Project and Quality Management Planning
  Developed a Project and Quality Management Plan for the global implementation of a clinical data management and statistical analysis system. This plan provided an overview of all processes and deliverables pertaining to the domains of project management and quality management as they relate to the development an deployment of the system.
• SOP Harmonization and Consulting
  Provided analytical and training assistance to a global pharmaceutical company in harmonizing global system development SOPs.  The scope of the SOPs covered all operations in North America, Europe, and Asia.
• Document Management Systems Development
  We have performed numerous document management systems development projects that included needs and requirements definition, software specification, software development, acceptance testing, validation, user documentation and user training. The projects have included document management systems for regulatory submissions, clinical study documentation, preclinical research reports, regulatory agency contacts and correspondence, product information, published literature, laboratory notebooks, SOPs and manufacturing records. These projects have been performed for U.S. and multinational pharmaceutical and biotechnology firms. Many of the projects required extensive interviews and detailed design sessions with user groups and information systems personnel.
• Enterprise Product Information Management Systems Design
  An extensive analysis of critical business needs, functional requirements and technical requirements was performed for a multinational health care and pharmaceuticals company. The project resulted in a report that defined the requirements for an integrated worldwide product information management system that included regulatory submissions, clinical information, manufacturing records and R&D documentation. The scope of the system included a central document repository, as well as the mechanisms that would support the access to information and its compilation into composite documents. Technologies that were reviewed included Topic, Folio, Acrobat, Documentum and various database management systems.
• Government Agency Information Management Analysis
  An analysis of current and expected information needs was performed to identify the functional and technical requirements of information management systems. The analysis included detailed interviews with members of the Agency Branches, their contractors, industry affiliates, and vendors of commercially available solutions. The Needs Analysis Report included a summary of the findings and recommendations for their general computing environment, databases, workflow management, information tracking and management, technical support, and data management.
• Imaging Systems Needs Analysis and Cost Justification
  We performed a needs analysis and consulting project that resulted in the development of a cost justification presentation to management and a Request for Proposal (RFP) for distribution to potential vendors for a pilot imaging project for case report form processing. The project included the analysis of procedures, resources and costs of central library, data processing, clinical research, and regulatory groups. The project analysis included the projection of costs of clinical data and document management using imaging technologies, and the design of a potential imaging solution that would meet the system requirements.
• Laboratory Notebook System Consulting
  We performed consulting services to help a worldwide health care consumer products company in an electronic laboratory notebook system development project. The project involved the use of Lotus Notes to enable product discovery and the patents/legal functions to assure the quality and integrity of critical documents and documentation.
• Medical/Statistical Document Management Process and Systems Analysis
  We performed an extensive needs analysis and consulting project that resulted in the development of a Systems Analysis and Recommendations Report for the biostatistical and information systems groups in an Italian pharmaceutical company. The project included the analysis of case report form development and management; clinical study information management; medical and statistical report production and document management; commercial product vendor analysis; human resource requirements; and computer capacity requirements. The project report included recommendations for computer systems architecture and capacity; organizational function and process workflow modifications; computer hardware and software; and pilot projects for document publishing and imaging.
• Multinational Documentation Management Needs Analysis and Systems Design
  We performed an extensive needs analysis and consulting project that resulted in a Systems Analysis and Design Document for Drug Regulatory Affairs computer systems in a multinational pharmaceutical company located in Switzerland. The functional areas included preclinical and clinical document management; international correspondence tracking; international package insert management; international adverse reaction monitoring; and regulatory project management. The project report included recommendations for 1) computer systems architecture, 2) capacity and technical support requirements, 3) publishing and imaging technologies, and 4) pilot projects.
• Technology Evaluation and Recommendations
  We have performed various projects for pharmaceutical, biotechnology, consumer products and contract research organizations to assist them in evaluating their needs and recommending technological and process re-engineering changes. The projects included extensive interviews with company personnel, analysis of in-house technologies and projects, literature research on technologies and experiences of other companies, technical reviews of vendor products, and detailed documentation of findings. Some of the technologies that have been evaluated included desktop video conferencing, imaging, pen-based computing, Internet/intranet, data conferencing and intelligent character recognition.
• Virtual Co-Location Analysis
  We performed an analysis of a multinational health care company’s ability to support a virtual co-location environment within their R&D organizations. The information was gathered from detailed interviews with employees, telephone interviews with other corporations, and published literature reviews. The report included an evaluation of the existing technologies and requirements, a review of industry trends, and recommendations for short, medium, and long-term projects to proactively improve their ability to achieve virtual co-location.
• Clinical Data Management Systems
  We have developed a number of clinical data management and adverse event reporting systems for various companies. We have developed systems and software facilities that collect, manage, analyze and report clinical trials and adverse event data using various programming languages and database management systems, including Access, Oracle, Ingres, Visual Basic, SAS, Clipper and dBase III/IV. These projects have included all phases of the development process, including requirements definition, software specification, software development and testing, user documentation and training, and validation testing and documentation.
• Clinical Data Coordination Application
  Multi-user, UNIX-based clinical data management application programmed in SAS for a large pharmaceutical company. This system is used for the entry, modification, and review of clinical data. The system contains facilities for the identification of exceptional data and extensive reporting options. We performed the system design, development, programming, testing, documentation, and training for the system.
• Preclinical System Program Design
  We designed the system architecture for a preclinical system. This system is used by a pharmaceutical firm for the collection, management, analysis, and preparation of preclinical data.
• SAS Programming Services in Clinical Trials
  We have provided SAS programming services in support of clinical trials for numerous pharmaceutical clients. These services included the preparation of clinical trial tables and analyses in support of numerous NDAs, including the areas of anti-infectives, dermatologics, anti-virals, neurologics, and vaccines.
• SAS Systems Integration
  We performed an analysis of existing patient data for a client, and using SAS AF programs, migrated it into PhClinical. We then integrated it with an imaging system that displayed case book images for the patient.

META Solutions applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.