ADB Consulting & CRO Inc.

Transcription

1 DATA MANAGEMENT, BIO-STATISTICS, CLINICAL OPERATIONS, QUALITY SYSTEMS & STAFFING SERVICES Abbreviated Edition December 2005 Advancing Data Management, Bio-statistics, Clinical Operations, & Quality Systems While Serving the Biomedical Research Community with Pride.

2 Page 2 Background Regulated industries such as food, pharmaceutical, device, and other biotechnological research companies continue to face increasing challenges in successfully conducting studies and marketing their product. ADB Consulting makes the ride to successful research and marketing as smooth as possible by providing proven solutions, advanced technology, and seasoned resources and staff. Our Clients' Challenges While technological advancement continues to make business operations easier, negative factors with potentially high stakes continue to be challenges for clinical research: - Limitations of knowledge and use of advancing technology - Choice of suitable process and practices to eliminate infeasibility of collected data - Growingly stern policies from the governing agencies - Higher degree of scrutiny - Increased financial costs - Burden of running multiple studies or conducting business nationally or globally. Our primary goal is to provide reliable solutions for these factors. Our Solutions ADB Consulting provides services that identifies, develops, implements, and qualifies solutions required to initiate and conduct clinical studies from the Data Management and Bio-Statistical perspectives. We provide solutions to these challenges by: - Understanding our clients needs for process, technology and resource - Fulfilling these needs cost-consciously by: o Applying our expertise of proven solutions for developing or enhancing our clients processes o Acquiring and implementing advanced, proven technology o And providing the seasoned staff needed to support the process and technology. - Providing out-service options which include proven solutions and seasoned support staff. - Ensuring the highest compliance by executing our extensive quality assurance at each stage of service for projects we undertake. Whether in or out-service, our team is heavily geared towards ensuring an expedited return of deliverables or completion of service while ensuring the highest quality. We recommend requesting additional information about our methods and processes used to accomplish the solutions we provide.

3 Page 3 Our Team s Strength and Background ADB Consulting is focused on placing individuals who have proven experience in the field and satisfy the requirements of their positions with a working knowledge of the related areas within the clinical research area. Therefore, our staff are able to ensure that the requirements are translated and applied correctly to avoid conflict, ensuring acceptance of our product and service. Our data management staff are also diverse in clinical operations and IT, while our bio-statistics team have working knowledge of the clinical/ medical operations, data management, and IT environments. Project leaders are a build of individuals experienced in directing multiple concurrent studies of established and startup biomedical companies. Since one of our main goal is maintaining compliance, all ADB Consulting affiliates are well versed in the regulatory requirements of the area they undertake. At ADB Consulting, our core team is built with the finest individuals that are poised at bringing their wide range of skills and vast experience to ensure that our clients operate their businesses at optimum with the highest potentials of success. Our Technology Our technology is at the forefront of those utilized in regulated Data Management and Bio-Statistics. ADB Consulting mainly supports application that have the capability of being configured as a client-server system maximizing our clients capabilities and success in achieving compliance with regulations. ADB Consulting offers a variety of solutions which are mainly triggered by project size, environment and budget. In the data management arena, we offer a variety of solutions ranging from paper to paperless and remote application access and administration. ADB consulting utilizes the most recent operating systems and provides extended support of all systems we build. ADB Consulting works towards ensuring that the technology being employed are tested and is one of the best solution for the project in which it is being used. Our Standards The services we provide are governed by our proven standards created from the years of experience of our experts. Our standards are some of the best business practices propelled by requirements of the clinical research governing agencies. The main goal of ensuring we operate by standards is to help maintain levels of quality, safety, reliability, efficiency, compatibility, and interchangeability at economical costs. In our data management processes and systems, we utilize standards, requirements, and guide-lines that are adopted by regulated and surrounding industries: - FDA (Food and Drug Administration). 21 CFR part 11, its guidelines and preamble

4 Page 4 are our fundamental tools in ensuring that our systems, services, and processes are within the acceptability standards of federal regulations. - ANSI (American National Standards Institute). In further ensuring are at optimum reliability, we utilize practices used by ANSI and its National Accreditation Program (NAP). - CDISC (Clinical Data Interchange Standards Consortium). CDISC was previously a special Interest advisory board to the Drug Information Association (DIA). Their mission is consistent with that of ADB Consulting: committed to the development of standards to support the collection, processing, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC is primarily based on the International Conference on Harmonization (ICH) guidance for Good Clinical Practice, specifically (ICH E6, E3 and E9) - ISO 9000 (International Organization for Standardization). ISO 9000 Standards has become internationally accepted; ADB consulting has adopted these standards and continues to ensure that our processes are well within these guidelines. - Application Users Group. ADB Consulting values global users and their experiences with the applications that we employ in our solutions. This interaction allows us to continually improve our system design, structure and use. Our standards are enhanced by our extensive knowledge and experience makes ADB Consulting a powerful force working for our clients. Our Services We provide both out-sourcing and in-servicing of Data Management and Biostatistics. Our services may be of a consulting, project management and/or staffing in nature. Out-Sourcing Services Our systems are able to handle projects with subjects of virtually any size. We employ manual, faxed and remote data entry systems based on our clients preference and service selection. We alter our project teams to meet the needs of the projects we undertake. ADB Consulting also understands the difficulty faced with outsourced projects; therefore, we are dedicated to eliminating those difficulties. We ensure our projects meet their timelines and our clients provided deliverables in their highest quality. Our management team is poised at keeping turnover rate at their lowest, ensuring our team members support their dedicated projects through their duration. We understand that the consistency of study conduct/management, and the retention of knowledge are key items to a successful trial. We exercise pride and dedication in the data management and biostatistics services we provide for each clinical trial outsourced to us.

5 Page 5 In-house Services On location, we are able to provide a complete set of data management and biostatistical services. Project sizes are of no significance; we resource developed systems/processes to developing/non-existent systems/processes. To be simply put, we can kick-start start-up groups or jump-start developed entities. We will work to understand the current system/process and its needs then recommend and implement solutions. Based on the services required, we can operate in-house on a project management, consulting or resource providing nature. When needed, our system/process integration method will acquire and place solutions for production use documenting and ensuring compliance as we do our in-house systems. Our continued support is targeted at ensuring that learning curves are minimized for systems and processes we integrate, so that our clients can take full control with confidence. Data Management We offer a wide variety of solutions that may be in or outsourced to us. Our services include: - CRF Management: CRF Development, Printing and Distribution. We design data collection tools using various application that are suitable for data collected using both faxed based and manual systems. We will execute the printing and manage the distribution of CRFs so that our clients are able to focus on other aspects of study management. - Database Development: Data Collection Tool Annotation, Database Design and Data Validation - Data Processing: Data Entry (dual and reconciliation options available), DCF/ Discrepancy Management, Quality Reviews and Data Audits - Medical Coding: Adverse Event and Drug Coding using Standard Dictionaries such as MEDDRA, WHODRUG, and other custom or standard dictionaries. - Reporting Monitoring, Adverse Event, Interim and other Data Analysis reporting to name a few. Many other reporting options available based on service selection. - System/Process Development and Enhancement: Design, Implementation/ Installation, Prospective and Retrospective Validation (applies to Clinical, Manufacturing, R&D, and Quality systems), and Maintenance. - Process/System Integration and Use: Database Development, System/database Training and Process Integration. - Compliance and Audit/Risk Analysis We conduct mock audits of the data management system and deduce risk analysis of existing systems and processes. We also provide solutions for our client to increase acceptability and reliability of their systems.

6 Page 6 Bio-statistics We offer various bio-statistical services that complements our data management services. Our wide range of services are offered at all stages of the clinical trial process, from study protocol development through study conduct to formal submissions. Our biostatisticians, affiliates, and programmers are seasoned in their field and have brought many studies of various therapeutic areas to regulating bodies. Services include: - Consultation- Offered for study protocol statistical components, data collection methods, data analysis methods, submissions strategy and other bio-statistical reviews. - Study Protocol Statistical Component Development - Sample size derivation and rationalization/justification, endpoint definitions and hypotheses, and establishment of other scientific soundness methods. We exercise knowledge and expertise in producing the most suitable methods. - Data Collection Methods - Defining case report forms (CRFs), database elements, and methods of data capture, increasing conformity to the study protocol. - Data Analysis - perform data analysis using data provided in most data formats (mdb, csv, xls, xml, txt, SAS (6-9), connections to relational databases etc.). Our programmers will execute data analysis plans returning deliverables with our highest accuracy. Their ability to execute data analysis in many operating environments increases our flexibility in dealing with various projects. - Automated Reporting Methods - we streamline standard reporting to create a more efficient process and system, minimizing the efforts needed for Interim, annual, and other standard reporting requirements. We strive to make the process seamless in crunch time. Our programmers will create solutions that are able to take data from database directly to reports in most cases. - Our services are also of an auditing and validating nature. - Auditing - We review statistical processes to ensure adherences to inhouse and regulated processes. - Validation - Our programmers will validate data analysis programs to increase confidence in data analysis routines.

7 Page 7 Bio-statistics (Continued) ADB Consulting provides risk assessment consulting at the pre-trial to submission stage of clinical trials. Our biostatisticians are ready to work with you providing knowledge and experience. Our bio-statistical programming support are built mainly of SAS Programmers as this has become the industry standard for analytical programming. Clinical Services ADB Consulting continues to increase our clinical operations offerings to be able to offer our clients a complete suite of services. Our Clinical Research Associate professionals, consultants and affiliates currently provide Study Design and Protocol Development, Clinical Data Monitoring, Collection and Auditing, Clinical Data Review & Management, and Data Safety & Surveillance. Study Design and Protocol Development ADB Consulting understands the importance of a good study design; therefore, we utilize the expertise of our staff to ensure that that all risks are minimized and that our clients objective will be met or exceeded. Some of the services offered includes the development of investigational plans, study protocols, informed consents, and case report forms. Study Initiation ADB Consulting utilizes a turnkey process to initiate clinical studies ensuring that all elements are in place and the foundation for study management is set. Our study initiation services includes but is not limited to: Investigator and site selection, Investigator meeting coordination, and Coordinator training and material preparation. Our staff are able to coordinate activities on or off our client site giving our clients the freedom from the hassles of study initiation. Study Management - Clinical Data Monitoring, Collection and Auditing Our Clinical Research Associates are well versed in most therapeutic areas and policies & procedures for a wide range of medical facilities increasing their efficiency and productivity when collecting clinical data They are dedicated to maintaining consistency in our data collection methods improving data accuracy and reliability. We understand that quality takes constant vigilance. Our services are available for all regions within the continental united states for manual, fax and remote data collection processes. The data auditing service include sampling and/or full data

8 Page 8 Clinical Operations (Continued) Study Management - Clinical Data Review and Management Our Clinical Data Review Team comprises of Clinical Research Associates professionals trained to study protocols and processes ensuring that all elements of the CRF data collected are in place and compliance is maintained. Some of the elements included in this service are: - Individual subject data review - Ongoing CRF data-collection compliance, evaluation and tracking - Corrective and Preventative Measure derivation and implementation - Drug and Device Accountability tracking and maintenance Data Safety & Surveillance Our Clinical safety Committee includes a team of physicians in a broad range of medical specialties. Our goal is to ensure the safety of clinical trials and more importantly, the safety of the subjects enrolled in such trials. The services offered include: - Data Safety Monitoring Board (DSMB) Meetings - Clinical Events Committee Meetings - Surveillance of Adverse Events for CRF report-ability requirements - Trending of reported Adverse Events - Medical Writing Equipment, Computer System, and Process Validation ADB Consulting provides validation services for equipments, computer systems and processes of Quality, R&D, Laboratory, and Manufacturing units. Our validation services includes a full suite of project management, design reviews, qualifications, testing, and training for the projects being validated. The validation services are reinforced by our development of standard operating and preventative maintenance procedures designed to ensure validation is maintained. The validation we undertake is geared at ensuring there is compliance to regulations set forth by the governing bodies such as the Quality System Regulations (QSR) of the FDA. Our method of validation of computer systems and ensuring that they are 21 CRF compliant is one of the most widely accepted by the FDA and significantly reduces the chance of negative findings during audits.

9 Page 9 Staffing ADB Consulting provides resources to our clients filling in-house needs. We support the staffing of areas beyond Data Management, Bio-statistical and Clinical Operation personnel. In addition we staff management, administrative, medical, engineering, manufacturing, information technology and more. We offer a variety of staffing solutions ranging from direct-hire, temporary, consulting, and temp-to-hire. ADB offers a full service staffing solution and is dedicated to providing a suitable relationship for our candidates and clients. Our prompt return with the most acceptable resource is a trait ADB Consulting is proud of. Why are we the best choice? ADB Consulting offers seasoned professionals utilizing the best practices in the data management and biostatistics area of biomedical research and regulated industries. We operate under proven standards that has built some of the largest companies around the globe. These standards consist of a pool of experiences from the IT, electronics, clinical operations, data management, bio-statistical areas. Our technical staff utilizes the most modern forms of technology ensuring that the system will be highly effective, reliable, safe, and a highly compatible user friendly solution for our clients operation. We harness these attributes and provide our clients with the power to overcome the obstacles and increase the potentials of a successful product research and an inevitable success. We are known for our wide variety of experience, zeal for the clinical research industry, thorough quality process, and highly structured standards of service. Contact us for additional information about our services. Web Site: Tel: 877-ADB-CCRO( ) info@adbccro.com