Data-management and Biostatistics

Transcription

1 Data-management and Biostatistics OnQ Data prides itself in being able to offer a cost-effective flexible service that result in the hassle-free generation of clean, high quality scientific data in the preparation for statistical analysis, at the same time, being compliant with regulatory guidelines.

2 Our Pledge Based on our experience in the Clinical Trial industry, we are confident that we offer our clients a satisfying solution for full Data Management services, from collection of data through to statistical analysis and clinical reporting, that will not only prove cost efficient but we also commit to the following: Provide a hassle-free solution for the entire (or part) data-management process, which meets or exceeds our clients expectations. Reduce costs by incorporating our economic advantage with our customised service model through our proprietary technologies. Accelerate timelines with our flexible and parallel delivery approach combined with the use of our proprietary tools for rapid data collection. The following brochure will provide you with an overview of our company and the quality of service we offer. We look forward to discussing your project with you Laurie Ben yair Managing Director Confidential Page 2 11/27/2012

3 3 TABLE OF CONTENTS Our Pledge... 2 Company overview... 4 Therapeutic area experience... 5 Our People... 6 Our System... 6 Our Standards... 6 Our IT Infrastructure... 7 Services... 8 Data-management... 9 Electronic Data Capture (EDC) Biostatistics Medical Writing Our SOPs Contact Information Confidential Page 3 11/27/2012

4 4 Company overview OnQ Data was established in 2003 and is a Contract Research Organisation dedicated to data-management, biostatistics and clinical report writing. Our clients consist of pharmaceutical, medical device and biotechnology companies. We provide an efficient and affordable data management service performed in accordance with the highest quality standards namely ICH Guidelines and FDA Regulations for registration purposes in the US and many European countries. We have completed studies in varied therapeutic areas. We have designed, managed and analysed a wide range of clinical studies, from small complex Phase 1 Oncology studies to large multi-national registration studies, with over 2500 subjects. Confidential Page 4 11/27/2012

5 5 Therapeutic area experience OnQ Data has had the opportunity to work in the following therapeutic areas: Oncology o Colorectal Cancer, o Breast, o Hepatocellular carcinoma Cardiovascular o Angina, o Venous Thrombosis, o Cardiometabolic Risk Factors Infectious diseases o HIV, o Malaria, o Tuberculosis Central Nervous System o Brain Injury, o Epilepsy, o Meningitis, o Insomnia Immunology Urology o Overactive Bladder Endocrine o Diabetes Mellitus, o Type II Diabetes, o Hypo-thyroidism o Nutrition Other o Soft tissue infection, o Surgery, o Vaccine o Healthy subjects o Medical device Confidential Page 5 11/27/2012

6 6 Our People While we emphasize our use of technology to provide efficient, cost-effective, and timely data-management services, our staff members remain our most valuable asset. OnQ Data recognizes our employees essential contribution to ensuring the scientific integrity of any project, therefore we continually invest in our employees by providing in-house training and regular attendance at scientific conferences and workshops. OnQ Data rewards performance with fair and competitive compensation and benefits. Our System OnQ Data utilizes a data management system specifically designed for the clinical research industry. Our system and SOPs meet all the FDA guidelines for clinical data management, namely; Guidance for Industry: Computer Systems Used in Clinical Trials and 21 CFR Part 11 of the Code of Federal Regulations. Our system manages all aspects of data auditing and access allowing our clients the peace of mind that their data will be captured and validated in compliance with FDA regulations. Our Standards At OnQ Data, we take Regulatory Compliance very seriously and understand wholeheartedly that data management can never fall short of complying with local and international regulations. We assure this by having our software, database and procedures validated periodically. Every action performed by our staff is governed by our own set of Standard Operating Procedures (SOPs) which manages all operations of our data management, biostatistics, and clinical research report writing departments. Our SOPs conform to all industry regulations set by FDA and ICH. Confidential Page 6 11/27/2012

7 7 Our IT Infrastructure Our IT infrastructure is designed to ensure the highest level of security to support our data-management and biostatistics services. In order to maintain the functionality of EDC, we have designed a multi-level network with multiple firewalls. Our internal IT environment has been developed to meet the FDAs requirements set forth by CFR Part 11 with our comprehensive SOPs governing all aspects of our IT processes from back-up, disaster recovery, system and software validation and change control. Our architecture ensures that only fully authenticated users are able to access our internal LAN. Our security protocols begin with controlled access to the premises, workstations and servers, followed by controlled access to the database and systems over the internet. Intrusion detection, virus scanning at all ports of entry, all electronic records transferred over the internet are encrypted using 128 bitencryption. Confidential Page 7 11/27/2012

8 8 Services OnQ Data s services cover the whole spectrum of data management WHODDE Being a dedicated Data management company, our team handles traditional paperbased data entry, or EDC with commitment and ease. Confidential Page 8 11/27/2012

9 9 Data-management At OnQ Data we pride ourselves in providing each client with a customized solution based on to their needs and specifications We are able to provide Paper, Electronic Data Capture or hybrid combination solutions. Supported by our leading edge data-management system and integrated SOPs, our team can fulfill unique project requirements, such as: o Accelerated database set-up and release o Sponsor defined CRF and DCF specifications o Speedy Query management o Unplanned data reviews o Timeline changes o Flexible approach to change requests A summary of our data-management services: CRF design Data management plan Data monitoring guides Data entering guidelines Database design/build and migration Data validation plan and edit specification Data validation and query management Database lock Quality assurance and quality control procedures 100% Double data-entry or part Lab database import / Loading external data Monitor / Site Training Coding of adverse events, concomitant medication and medical history Toll free support lines Medical/scientific review SAE reconciliation Medical coding WHOART, MedDRA, WHO- DDE and MDR Confidential Page 9 11/27/2012

10 10 Electronic Data Capture (EDC) Our robust EDC solution is designed specifically for clinical trials, therefore providing a user-friendly and secure environment complying with all aspects of CFR Part 11. Our competent teams of Data managers manage the entire EDC process, keeping our clients continually informed via study update reports. Our EDC system enables the study sites the ability to enter and manage their own CRFs, run reports and view study documents via a web style interface. Our software is designed to resemble windows toolbars, making it user-friendly and uncomplicated to manage entry and cleaning of data. The patient search feature provides a link to the actual study data (PDF format), with print or download capabilities. A test database is launched prior to first patient entry, allowing the sites time to familiarise themselves with the system. A fully functional audit trail is in place and is able to be printed/saved for archiving in study files. Our IT department maintains and hosts our systems, and manages a fully operational support desk. OnQ Data is able to conduct your study as EDC, paper-based or a hybrid of methodologies. You don't have to be locked into one data collection method or have your data collection method lock you out of sites - you can choose the best methodology for each site, all within one unified solution. Confidential Page 10 11/27/2012

11 11 Biostatistics OnQ Data understands that sound data analysis is the key to reliable clinical trial results and provides a statistical approach tailored to your study objectives. Our biostatistical services can be customised to the clients individual needs ranging from sample size calculations, SAS programming according to your analysis plan to in-depth statistical analysis for registration. It is our goal to help you develop the most robust conclusions possible, this way the biostatisticians team-up with our programmers to determine the optimal method for collecting, analysing, and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customised tables, optimised for unique study designs. At OnQ Data we believe solid statistical data analysis depends on careful planning, and therefore a statistician is involved throughout the lifespan of a project. Our biostatistical services include: Assistance in planning and trial design Writing of statistical sections of protocol Randomisation plans Statistical analysis plans SAS programming (tables, graphs, listings) Statistical analysis Statistical report Our QC process involves reviewing the scientific integrity of the analysis to ensure consistency with the protocol, SAP and database. Confidential Page 11 11/27/2012

12 12 Medical Writing OnQ Data s Medical Writing team produces expert clinical documentation (Protocol, Clinical Reports or publications) that are clear, concise and scientifically accurate with format and content in strict accordance with prevailing regulations and guidelines. Our medical writers combine critical-thinking and project-management skills with the ability to clearly communicate complex medical and scientific topics. A list of some of our medical writing services: Integrated clinical reports (ICH E3) Abstracts and Manuscripts Statistical Reports Protocol writing Confidential Page 12 11/27/2012

13 13 Our SOPs SOP No. SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-DM SOP-IT SOP-IT SOP-IT SOP-IT SOP-IT SOP-BS Title Case Report Form Development Pre-entry Review Data entry Database Structural changes Database set-up and validation Database lock and unlock Electronic Data Capture Handling and Tracking of Case Report Forms Medical Writing System validation and change control System control and security Development and Approval of a Data Management Plan CRF annotation and Naming Conventions Data export in SAS Training Coding Dictionaries Remote use of computer Quality Control Process SAE reconciliation Development and Handling of SOPs and Templates Coding of Adverse Events Disaster Recovery Plan External Data Loading and validation Digital Pen Data Upload Data Privacy EDC Set-up Application and Computer System(s) Requirements for complying with 21 CFR Part 11 Document Archiving Procedure Edit Check Specifications Edit Check Validation Change Control Electronic Passwords Electronic Case Report Form Development EDC training External Data upload Document Storage Database back-up and archiving Version/change control of software and hardware Mapping of SAS Datasets Biostatistical Analysis Confidential Page 13 11/27/2012

14 14 Contact Information Laurie Ben-yair Managing Director OnQ Data, (Pty) Ltd Unit 3, 62 Blaauwberg Road Tableview, 7441, Cape Town, SOUTH AFRICA Telephone: / 9788 Fax: laurieb@onqdata.com Website: Confidential Page 14 11/27/2012