Needs, Providing Solutions

Transcription

1 Identifying Needs, Providing Solutions

2 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved substantially over the recent years making the operating environment quite challenging. Extended development time, financial constraints and limited resources coupled with inefficient processess, has made the development process very restricted. According to industry estimates, the process of bringing a new drug to the market could take up to 10 years at a cost of millions of dollars to complete. The industry has recognized that regulatory and competitive pressures has forced clinical organizations to come up with alternatives and more efficient ways to manage clinical development process. During the continued work of these companies in the area of research, the partnering with a nitch Contract Research Organization (CRO) company to support their clinical trials and to tailor services specific to their clinical process and business objectives which can also help drive down cost in the continued success of drug development. C o v o x x O v e r v i e w The clinical trial industry faces a significant challenge meeting demands during the drug development lifecycle. Our vision for the future of clinical trials, is to tailor services to organization s clinical requirements to meet thier needs. Organization s are changing the way in which they view data management and their clinical trials. Covoxx understands that the success of our sponsors clients depends on the timely and accurate collection of clinical trial data. The timely process has direct impact on the time it takes to get our Sponsors product to market. We combine our process with the best technology available to accomplish our data management data collection. C o r p o ra t e P r o f i l e Covoxx is a newly established Contract Research Organization (CRO) with 14 years of data management experience in many therapeutic areas. We provide data management, biostatistics and clinical research reporting. Our mail clients are Pharmaceutical, Biotechnology and Medical Device companies. The director of data management at Covoxx has completed nearly 100 studies in a wide range of therapeutic areas in all 4 phases and has worked in the pharmaceutical, biotechnology and CRO environment. Our data management has also designed, managed and analyze clinical studies ranging from small complex phase II cancer trials to large global registrational trials with about 3 years in duration and 1000 patients. Covoxx is dedicated to provide all of its clients with the most secure, regulatory compliant, cost-effective data management and biostatistics servicess. Our data management and biostatistics groups are governed by rigorous SOPs and complies with ICH and GCP guidelines as well as FDA 21 CRF Part 11 regulations for electronic data capture.

3 2 T h e ra p e u t i c A r e a s Covoxx has extensive experience in the following therapeutic areas: - Arthritis - Infectious Diseases - Cardiology - Oncology - Central Nervous System - Organ Transplantation - Dermatology - Respiratory - Endocrinology - Vaccines - Gastroenterology Services Covoxx is committed to providing quality data management, statistics and medical writing services from CRF design through database lock and final study report. We provide consulting and strategic guidance backed by extensive knowledge, expertise and experience in clinical development and research. D a t a M a n a g e m e n t Covoxx will provide our clients with clinical data management solutions that are client specific, cost effective, secure, regulatory-compliant and an expedited data collection process on any of the data collection methods our clients choose. Whether our clients choose to collect their data on paper or through electronic data capture (EDC), Covoxx provides the tools need to efficiently manage trial information. With our EDC capability, we are able to produce automatic edit checks, real-time data queries, query resolution and complete audit log. Covoxx EDC systems also allows for instant reports facilitating FDA paper-trail management. Our leading-edge data management system allows our data managers to fulfill unique project requirements such as: - Quick database set-up - Validations review and programming - Customized query wording for clarity and consistency - Query management - Study timeline changes We are able to accommodate changes to project specifications providing complete audit trail and the same time, we maintain the study data quality and keeping with sponsor timelines. Our system is equipped to capture data in the following methods: - Paper - traditional paper method - Fax - EDC - Web based

4 3 The following is a summary of our data management services and procedures: Data Management Plan - Project specific data management standards and SOP s Database Design - Database definition - Database Security - Data entry screens Data Validation Plan - Programming and query wording - Testing Validation Plan Data Entry (paper) - Ongoing double data entry and verification from CRFs - Data entry cleaning Medical/Science Review - Review of data alerts - Medical evaluation of data SAE Reconcilation - Reconciliation done based on safety data and study database Coding - Adverse events coding using MedDRA dictionary - Concomitant drugs coding using WHODRUG Data Validation and Query Management - Web-based query resolution management - Periodic validation of CRF data Centra Lab Data Import Database Lock and Audit - Final database lock with all associated documents Database Documentation - Sponsor defined database transfer format (ASSCII, SAS etc) Our data managers follow internal QC and QA process to ensure the quality and accuracy of the study. The QC process involves periodic review of CRF and DCF tracking and filing, data entry errors and data management procedures and a comparison of data entry and original paper CRFs. We QC the integrity of the database by ensuring the consistency between the Protocol and the database. We ensure the data management process complies with study specific SOPs. E l e c t r o n i c D a t a C a p t u r e ( E D C ) Our EDC database is user-friendly secure environment that works with any web browser and it s fully compliant with FDA requirement 21 CRF Part 11. The system can be accessed by our Sponsors at any time making it a unique and distinct advantage to our Sponsors to have full access to their data at any time. Our process includes: - Rapid study set-up - Design user-friendly data entry screens - Online data validation - Produce study status reports and data listings - Database exports and lock The entire study team can easily navigate through our system to review study data including query management. We maintain the system internally to have access to a fully operational support desk.

5 4 Bi o s t a t i s t i c s We offer to our Sponsors a range of services from our biostatistics group. From the design and analysis of clinical trials ranging from parallel group, cross-over to complex (population) pharmacokinetic to large variable sample size sequential designs. The biostatistics services is customized to our Sponsor individual needs ranging from SAS programming as per the analysis plan, to stats support of registration trials. We can design the registration trial design according to the therapeutic area, specific regulatory guidelines and provide Sponsor presentation at IND meetings in support of the design and analysis plans. Our biostatistics services include the following: - Writing the Statistical Analysis Plan (SAP) - Drafting and programming Tables, Listings, Figures (TFLs) - Sample size calculation - Randomization - Formal interim and final statistical report - Study specific documents - Statistical consulting Coxoxx Biostatistics and SAS Programmers follow strict company SOPs to ensure consistency and integrity of the study result. As part of our QC process, we review our programming standards periodically to ensure we are following the best scientific procedure. We review our programming structure, unit testing and our electronic filing of all our programs. At the conclusion of the study, the entire process is QA d to assess compliance with study specific and Covoxx SOP s. Our SOP s are alo able to accommodate: - Client designed analysis standards - Third party databases - Timely response to ad-hoc request - Third party collaboration for report and manuscript writing. We are flexible in accommodating changes to project specifications and keeping a complete audit trail of those changes. At the same time, we maintain the integrity and quality of the data adhering to expected project timelines.

6 5 C l i n i c a l R e s e a r c h R e p o r t s Covoxx prepares clinical research reports as part of our services. Our biostatistical service is supplemented by the production of reports that includes summary tables and graphics, clinical data listings and statistical analysis.. All of our reporting interpretations maintain consistency with our SOP s, the study Protocol, the Statistical Analysis Plan and study data. Our medical writers accuracy and clarity to all reports. Covoxx will provide a range of reports to supplement our Sponsors final study data. The following are the report writing service we offer: Clinical Research Reports: - Statistical Report - Integrated Clinical Research Safety Report Interim efficacy report Ad-hoc exploratory analyses report Integrated Summary of Safety and Efficacy Reports Abstracts - Medical writing - Graphics and visuals Data Management C o n s u l t i n g S e r v i c e Covoxx offers deep clinical data expertise to its clients through the implementation of strategic consulting services such as Clinical Trial Process Consulting, SOP development, CDISC, Vendor Management, Vendor Audit, User Acceptance Testing (UAT) and validation. Our consulting delivery model empowers you to make and implement better strategic business decisions through an unequalled combination of our clinical domain experience and deep operational understanding to best serve your scalable needs.our team recognizes the importance of the processoriented methods necessary to ensure consistent quality. As a result, we offer unparalleled diversity and depth of experience in developing consulting solutions. Above and beyond the quality deliverables for your project, Covoxx team is uniquely able to leverage a distinctive combination of industry expertise, technical depth and differentiated services to deliver powerful consulting solutions to our clients.

7 6 Contact Us Covoxx, Inc. 941 Washington Avenue, Suite 5-B Brooklyn, New York Phone: Fax: