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Capabilities and Services for Clinical Research

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  1. Capabilities and Services for Clinical Research Capabilities and Services for Clinical Research July 2010

  2. Presentation Outline • Our Mission • Company History and Overview • Capabilities and Services • Systems and Tools • Processes and Procedures • Experience and Expertise

  3. Our Mission To be a strong clinical research partner of pharmaceutical and biotechnology companies to develop and commercialize their products with high quality and cost-effectiveness to improve the health and wellbeing of the general public. To continue our strong efforts in building a center of excellence in what we do.

  4. Company History and Overview • Previously, a well-established and high performing unit of Pharmacia Corporation, with 12 years experience in providing statistical and data management services. • Became an independent Contract Research Organization (CRO) in January 2004 after the Pfizer acquisition of Pharmacia. • Have been successful for more than 6 years operating as an independent CRO. Built partnership or preferred vendor relationship with a number of major pharmaceutical companies and other smaller pharmaceutical and biotech companies. • Have offices located in Toronto, Ontario, Canada and in Little Falls, New Jersey, USA. • Promote High Quality Standards, Customer Focused, Can-Do Spirit, Advanced Technologies, Continuous Improvement, and high level Ethical and Professional Standards.

  5. High Quality Standards Customer Focused Can-Do-Spirit Advanced Technology Continuous Improvement Ethical and Professional Legacy Pharmacia Statistical Operations Unit We Continue the 12-Year Legacy Built Under Pharmacia We Continue to Strive to Become A Center of Excellence for What We Do

  6. Capabilities and Services • Biostatistics and Statistical Programming • Clinical Data Management, Medical Coding • Trial Subject Randomization using IWRS (Interactive Web-based Response System) • Trial Drug Dispensing and Inventory Management using IWRS • Development and Maintenance of Web Portals and Study Websites • Medical Writing for Protocols, Clinical Study Reports, Abstracts, Manuscripts, Posters, Regulatory Submission Summaries,etc. • Regulatory Submission Support Using eCTD • Administration of Clinical Trial Data and Safety Monitoring Boards • Trial Management and Site Monitoring Using Partnering Clinical Management Firms

  7. Finance/Accounting and Legal Services President/CEO Scientific and Operational Advisory HR, Training, Corporate Affairs Strategic Planning & Business Development, Contract Negotiation Clinical Data Management Biostatistical Sciences Medical Coding, Safety Monitoring, Medical Writing Network & Security, System Administration, Web Technologies Statistical Programming & Database Administration Regulatory Submission Support (eCTD) Project Management & Quality Delivery Quality Assurance and Compliance Functions and Structure

  8. Biostatistics and Programming Services • Trial design, protocol development, sample size calculation, subject randomization, data analysis and report writing for Phase I – IV trials. These services are provided following ICH, GCP, and FDA guidelines and using well-designed workflow processes and procedures (SOPs), including templates for Clinical Trial Protocol, Statistical Analysis Plan, Statistical Analysis and Programming QC/QA Plan, Statistical Report, and Clinical Study Report, etc. • Statistical input for drug development program design. Participation in drug submission activities and interaction with regulatory agencies • Statistical analysis of trial data, as well as data from retrospective observational studies and patient registries for abstracts, manuscripts, presentations and posters • Statistical consultation • Exploratory data analysis for completed trials – for publications, signal detection, and new trial development • Preparation of datasets using CDISC standards for statistical analyses and drug submissions to regulatory agencies

  9. Clinical Data Management Services • CRF/eCRF design, data review and cleaning, data coding, 3rd party data integration and cleaning, real-time access to data queries and trial progress reports, database lock, and final archiving. These services are provided following ICH, GCP, and FDA guidelines, using validated systems (21 CFR Part 11 compliant) and well-designed workflow processes and procedures (SOPs), including templates for standard CRFs/eCRFs, Data Management Plan, User Acceptance Test Plan, Data Review Checklist, Database Quality Acceptance Sampling Plan, Database Lock Checklist and Sign-off Sheet, etc. • CRF design using FrameMaker • Data capture and management using both Electronic Data Capture Systems and Paper-based System (refer to next slide) • Database integrity checks and trial monitoring reports within data management systems, and outside data management systems using SAS • Medical terminology coding using MedDRA, medication coding using WHODRUG • Dissemination of database information, subject progress and trial monitoring reports using EDC systems andStudy Websites

  10. Main Data Management Systems Electronic Data Capture Applications: • InForm (Phase Forward) • iDataFax (Clinical DataFax Systems Inc.) • Everest also uses other EDC systems. Above mentioned systems are our main data management systems. Paper/Fax-Based System: DataFax - Data management system for paper/fax-based data collection This system can handle both EDC and paper CRFs within the same database. A trial can be completely paper-based, or can use both paper/fax CRFs and EDC eCRFs (iDataFax). In this case some sites could use web-based EDC data entry and other sites could send in paper CRFs to the data center for centralized data processing.

  11. Quality and Timely Data Collection, Cleaning, and Database Lock Using EDC Applications • Data review, querying, and reconciliation are performed promptly as data is entered by the study sites. Outstanding queries are kept to a minimum • Data review, querying, and reconciliation processes for individual studies are outlined in the Data Management Plan (DMP). Cleaning and review of the data is on-going throughout the study lifecycle up to database lock • Database acceptance checks are performed by the internal statistical team during the initial data extraction test run, and the dry runs for interim and final analyses. This process ensures database issues are detected and resolved early • The database can be locked within 5 working days of the last subject’s last visit and receipt of last subject’s data records, including electronic data transfers (central lab data, eDiaries, PROs, ECGs, other specialty labs, etc.) • A database lock checklist is followed to ensure all steps including coding, medical review, SAE reconciliation, 3rd party data transfer and cleaning, statistical dry runs, and SAP sign-off, etc. are all completed prior to locking the database

  12. Quality and Timely Data Collection, Cleaning, and Database Lock Using Paper/Fax-based System • Electronic CRF images for the completed CRFs are accessible by authorized trial personnel via a secure Web Portal/Study Website • Data review, querying, and reconciliation are performed promptly as CRFs are received. Outstanding queries are kept to a minimum • Data review, querying, and reconciliation processes for individual studies are outlined in the Data Management Plan (DMP). Cleaning and review of the data is on-going throughout the study lifecycle up to database lock • Database acceptance checks are performed by the internal statistical team during the initial data extraction test run, and the dry runs for interim and final analyses. This process ensures database issues are detected and resolved early • Database can be locked within 5-10 working days of the last subject’s last visit and receipt of last subject’s data records, including electronic data transfers (central lab data, eDiaries, PROs, ECGs, other specialty labs, etc.) • A database lock checklist is followed to ensure all steps including coding, medical review, SAE reconciliation, 3rd party data transfer and cleaning, statistical dry runs, and SAP sign-off,etc. are all completed prior to locking the database

  13. Trial Subject Randomization Using IWRS • Statistical consultation on trial design, sample size estimation and justification, and subject randomization requirements and procedures • Developing IWRS user requirements and specifications, facilitating sponsor review and confirmation, and obtaining authorization of the user requirements and specifications • Designing and development of IWRS database and web interface, implementing functionalities as specified in the IWRS user requirements and specifications • Designing and development of IWRS User Acceptance Test (UAT) Plan with test scripts. Execution of the test plan, reporting and addressing test findings, releasing IWRS for sponsor UAT • Facilitating sponsor UAT and incorporating sponsor’s UAT comments • Deploying IWRS and conducting user training using a parallel and independent training IWRS website, which has the same functionalities as implemented in the production IWRS for the trial • Performing IWRS maintenance, monitoring and user support • Ongoing data transfer to sponsor via a secure file transfer protocol

  14. Study Drug Dispensing and Management Using IWRS • Consultation and discussion with sponsor trial team and drug supply personnel on drug supply and management requirements (e.g. subject visit and dosing requirements, drug supply flow, central and local depots, shipment methods, quantity on initial release and re-supply, handling of damaged drugs, low inventory alerts, drug supply and inventory monitoring reports, etc.) • Developing IWRS user requirements and specifications, facilitating sponsor review and confirmation, and obtaining authorization of the user requirements and specifications • Designing and development of IWRS database and web interface, implementing functionalities as specified in the IWRS user requirements and specifications • Designing and development of IWRS User Acceptance Test (UAT) Plan with test scripts. Execution of the test plan, reporting and addressing test findings, releasing IWRS for sponsor UAT. Facilitating sponsor UAT and incorporating sponsor’s UAT comments • Following the same processes and procedures as those used for the subject randomization components of an IWRS for deployment, user training, system maintenance and user support

  15. Advantages of IWRS Over IVRS • IWRS is more cost-effective than IVRS (eliminates the need for voice recording, editing, and programming) • Set up time for IWRS is much shorter than that for IVRS. The same is applicable to changes or modifications to the validated system • Visual display instructions (IWRS) are easier to follow than audio instructions (IVRS) in an international clinical trial setting • IWRS uses simple instructions on data entry screens, which minimizes the need for multiple languages for IWRS applications in international clinical trials • Fewer key entry errors may occur using IWRS than using IVRS (computer keyboard vs. phone keypad) • IWRS login is integrated within EDC systems or Study Web Portals/Websites

  16. Development and Maintenance of Trial Web Portal/Study Websites • Each trial sponsor may have a secure trial web portal where Study Websites may be built • Authorized trial personnel will have access to the Study Website for trial related information (sponsor will decide what will be made available on the Study Website: trial documents, trial team and site contact information, trial benchmarking and monitoring reports, etc.) • Access control, monitoring, and user support are provided according to SOPs

  17. Medical Writing of Clinical Study Reports and Publications • Write clinical trial Protocols, Clinical Study Reports (CSR), abstracts, manuscripts, and develop presentations/posters • For each trial, a medical writer with previous experience in the study disease area will be identified and teamed with a biostatistician, a QC reviewer, a graphic designer if necessary, and document publishing support personnel • Sponsor provides CSR template, or Everest CSR template will be used (compliant to ICH E3 CSR guidelines) • A CSR Shell will be developed and reviewed by internal peer reviewers. Sponsor comments will be obtained and incorporated before a full CSR will be drafted • Facilitate review cycles of the draft CSR. Finalize CSR when all comments have been properly addressed • CSR publishing procedures and final QC/QA review will be performed before CSR sign off

  18. Regulatory Submission Support Using eCTD • Many eCTD submissions are sent directly to US (FDA) and European (EMEA) regulatory agencies on sponsor’s behalf:No agency validation findings/faults • Submissions can be sent electronically to FDA through their Electronic Submissions Gateway (ESG) • In-house submission build: options for document publishing, CDISC dataset preparation, SPL build, Standard Letter or A4 paper submission printing available for agencies or EU Member States • Dedicated server able to send and receive documents by secure VPN connecting to sponsor • SOP controlled process from start to finish. Sponsor audited; FDA remote audit of documentation in July 2008 (FDA on site at sponsor) with no findings/faults • Regulatory support for agency communications available through partnering regulatory firms

  19. Administration of Clinical Trial DSMBs • Write Charters for clinical trial Data and Safety Monitoring Boards (DSMB) • Identify and engage board members • Design and develop trial data review summary tables, subject data listings, and graphs (TLGs) • Generate and validate trial data review TLGs and provide them to the DSMB prior to the DSMB data review meetings • Schedule and facilitate DSMB meetings, take meeting minutes (DSMB Secretary) • Interact and communicate with trial sponsor and with regulatory agencies on behalf of the sponsor in accordance with the DSMB Charter

  20. Trial Management and Site Monitoring • Everest is continuing to develop its clinical trial management and site monitoring capabilities by working seamlessly with its partnering clinical management firms to provide quality services in clinical operations • Trial sponsors benefit from the combined powers of two strong functional service providers while administratively dealing with a single point of contact (one primary contact from the combined teams per trial, single contract for each trial, and a single invoice will cover services from both partnering companies) • Through the years conducting clinical trials together, both companies know about each other’s processes and procedures, systems and tools. Function as a unified organization • One set of SOPs will be followed per functional area

  21. Trial Sponsors’ Feedback “It has been a great pleasure to work with the Everest teams.” “They are highly motivated and always go above and beyond to provide us with quality and timely services.” “You are really a ‘Can-Do’ team! You always try your hardest and find solutions for problems…. your ‘Can-Do’ attitude results in continuous improvements in all of the things you do….” “We are very impressed by everything your team has done, they have contributed a lot to the success of the projects.”

  22. Oncology Immunology/Autoimmune/ Rheumatology Hepatology Virology Allergy/Respiratory Infectious Diseases Nephrology Vaccines Cardiovascular Diseases Endocrinology Urology Ophthalmology CNS Women’s Health Dermatology Medical Devices Therapeutic Area Expertise and Experience

  23. Benefits of Using Our Services • “Quality is our backbone, Customer-Focused is our tradition, Flexibility is our strength” – these are our top three success factors • Due to the low overhead of the organization, quality and timely services can be offered at a competitive rate • Well-defined and streamlined processes and procedures enable efficiency gains and error prevention • Standardization in systems/tools, CRFs/eCRFs, datasets, common data displays, standard SAS programs, standard work templates or checklists, etc., enables resources/cost saving • Everest’s relatively stable workforce enables knowledge and experience retention, minimizes the costs of hiring and initial investment in developing new staff members • If the trial sponsor has a Canadian operation, a portion of the cost of using Canadian CROs may be claimed through the Canadian government’s SR&ED tax incentive program

  24. Everest Contact Information Irene Zhang Office Phone: 1- 905 - 752 - 5201 Office Phone: 1- 973 - 774 - 1160 Cell Phone: 1- 416 - 788 - 8678 Website: www.ecrscorp.com Company Locations: 675 Cochrane Drive Suite 408, East Tower Markham, Ontario Canada L3R 0B8 150 Clove Road Suite 502 Little Falls, New Jersey USA 07424