Clinical Data Management


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Clinical Data Management

  4. 4. CLINICAL DATA MANAGEMENT SYSTEM INTRODUCTION A Clinical Data Management System or CDMS is used in clinical research to manage the data generated by the conduction of a clinical trial. The clinical trial data gathered at the investigator site in the Case Report Form(CRF) is stored in the CDMS. CRF is a paper or electronic questionnaire, used as a tool by the sponsor of the clinical trial to collect data on each patient from each participating site. CDMS also performs coding of data. Standard dictionaries of Adverse Event Terms (Multiple terms, developed by different cancer therapy modalities, e.g. acute/late effect, side effect, complication, etc.) and Medication/Drug Names can be loaded into the CDMS,enabling matching of common abbreviations and mapping them to the correct term. For e.g., ASA could be mapped to Aspirin. Popular Adverse Event dictionaries : MedDRA and WHOART Popular Medication dictionaries : COSTART and WHO-DRUG. At the end of the clinical trial, the dataset in the CDMS is analysed and sent to the regulatory authorities for approval.
  5. 5. CLINICAL DATA MANAGEMENT SYSTEM NEED FOR CLINICAL DATA MANAGEMENT <ul><li>According to Cutting Edge Information, the total research and development cost incurred is running overboard by 37%, causing pharma company budgets to exceed $400 million in total expenses. </li></ul><ul><li>Drug companies need to find ways to cut both costs and time from the clinical development process. </li></ul><ul><li>Incorporating Clinical Data Management lets managers and team members: </li></ul><ul><li>Get an accurate, real-time view of clinical trial forecasts and budgets </li></ul><ul><li>Effectively use critical information and collaboratively assess performance. </li></ul><ul><li>Ultimately, goals are reached sooner, and the entire process is more cost-efficient. </li></ul><ul><li>The 3 principal factors that govern Clinical Data Management are: </li></ul><ul><li>Aggregation of data and its Dissemination via an open framework </li></ul><ul><li>Configuring Key Performance Indicators (KPIs) such as metrics specific to trial, patient retention and enrollment rates, etc. </li></ul><ul><li>Updating of tools - from spreadsheets to scorecards and dashboards - to limit error, improve control, enhance visibility, and boost accountability. </li></ul>
  6. 6. FUNDAMENTALS OF CLINICAL TRIAL SOFTWARE <ul><li>Today’s business-intelligence softwares are able to: </li></ul><ul><li>Accelerate study timeline and control costs without sacrificing the quality of study results </li></ul><ul><li>Provide accurate predictions of clinical trial operating expenses </li></ul><ul><li>Enable robust modeling of an entire development program </li></ul><ul><li>Provide data and forecasts based on actual activity and spending </li></ul><ul><li>Facilitate recruiting, screening, scheduling and tracking patients and also assist with the stringent requirements regarding doctors and institutions </li></ul><ul><li>Integrate seamlessly with other financial and operations software </li></ul><ul><li>Automatically adjust for foreign exchange rates </li></ul><ul><li>Update accounting information real-time </li></ul><ul><li>Ensure compliance with HIPAA, FDA regulatory guidelines, GCP, 21 CFR Part 11 and even with European regulatory guidelines </li></ul><ul><li>Facilitate better management at every level, for a faster, more cost-efficient process </li></ul>Pharmaceutical, biotechnology, medical device and research organisations can all benefit from clinical trial software. Clinical trials data management software assists with all aspects of a trial - from enrollment to study submission to study archiving. Clinical trial software can be used for small Phase 1 trials or large studies with thousands of participants.
  7. 7. ORACLE CLINICAL SOFTWARE <ul><li>Oracle Software makes implementation faster, team more effective, marketing more productive and return </li></ul><ul><li>on investment higher. </li></ul><ul><li>Oracle University delivers in-depth product training, so one can learn to implement and manage Oracle </li></ul><ul><li>Database, applications, tools, and technologies efficiently and effectively. </li></ul><ul><li>Oracle Consulting allows one to optimise the value of Oracle investment, while minimizing the total cost of </li></ul><ul><li>ownership. </li></ul><ul><li>Oracle’s Global Customer Programs serve the needs of customer companies. </li></ul><ul><li>Oracle also provides independent users’ groups communities that provide dynamic forums for customers to </li></ul><ul><li>share information, experiences, and expertise. </li></ul><ul><li>Oracle Premier Support helps unlock the power of solutions by reducing the time, effort, and cost of </li></ul><ul><li>operating Oracle system. </li></ul><ul><li>Oracle Clinical is a sophisticated solution that helps one meet the biggest challenge: how to get to market </li></ul><ul><li>faster in today’s complex business and regulatory environment. </li></ul>About Company <ul><li>For almost 30 years, Oracle has been helping customers manage their business </li></ul><ul><li>systems and information with reliable, secure, and integrated technologies. Oracle </li></ul><ul><li>spends more than US$2 billion annually on research and development. </li></ul>
  8. 8. ORACLE CLINICAL SOFTWARE <ul><li>Key features include: </li></ul><ul><li>Provision of integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) application on the </li></ul><ul><li>market, while also providing best-of-breed CDM and RDC functionality. </li></ul><ul><li>Smooth transition from paper to EDC (Electronic Data Capture) trials. </li></ul><ul><li>Annotated CRFs – provides an intuitive means of creating submission-ready annotations. </li></ul><ul><li>Improved randomisation – leverage the built-in functionality of the Oracle Database. </li></ul><ul><li>Built-in automated test environment. </li></ul><ul><li>Accept CDISC compliant transactions. </li></ul><ul><li>Flex fields - provide customisable information fields in header/footer of CRFs. </li></ul><ul><li>Auditing – extends existing audit trail features to ensure industry compliance. </li></ul><ul><li>Data Extract - denormalised, easy-to-read view of study data. </li></ul><ul><li>Industry Proven. </li></ul>About Software Oracle Clinical was built based on the extensive experience of hundreds of companies that conducted clinical trials—which gives Oracle Clinical an essential industry perspective. More than 200 companies representing pharmaceutical, biotechnology, medical device, and contract research organizations have relied on Oracle Clinical to conduct more than 10,000 clinical trials.
  9. 9. SAS CLINICAL SOFTWARE <ul><li>SAS' record of revenue growth every year, since 1976, enables reinvestment of a substantial percent of </li></ul><ul><li>revenues in R&D each year (21 percent in 2007). </li></ul><ul><li>SAS customers receive a full suite of support services at no extra charge, including skilled telephone </li></ul><ul><li>technical support and unlimited, around-the-clock online technical support. </li></ul><ul><li>SAS for Clinical Data Integration helps to reduce time-to-market for new drugs. </li></ul><ul><li>SAS streamlines data integration to eradicate errors and manual work that delay bringing novel therapies to market. </li></ul><ul><li>SAS® Clinical Data Integration Server provides a platform for life sciences organisations to define, </li></ul><ul><li>manage, and automate their processes for aggregating medical data through the use of standards such as </li></ul><ul><li>CDISC. </li></ul>About Company <ul><li>SAS is one of the largest software companies in the world. SAS solutions are used at 44,000 sites in 109 countries – including 96 of the top 100 FORTUNE Global 500® companies. </li></ul>
  10. 10. SAS CLINICAL SOFTWARE <ul><li>The software is loaded with the following functionalities: </li></ul><ul><li>Builds single, integrated platforms that let one access and manage data from a wide range of sources— </li></ul><ul><li>including EDC systems, in-house CDMSs, labs and CROs. </li></ul><ul><li>Identifies and automates repeatable processes based on a common platform to reduce manual intervention, </li></ul><ul><li>speed processes and improve decision making. </li></ul><ul><li>Ensures the proper use of standards by analysing both the structure and the content of the data and using </li></ul><ul><li>CDISC standards such as ODM and SDTM. </li></ul><ul><li>By using SAS to manage and automate data integration, data quality and compliance with industry </li></ul><ul><li>standards, one can free up valuable resources to work on more complex and strategic projects, and hence, </li></ul><ul><li>save time. </li></ul>About Software SAS understands that each stage of bringing a drug to market has unique needs. SAS Solutions for Life Sciences looks to distinctly address these needs through a portfolio of integrated solutions that drive efficiencies throughout every stage of a drug's lifecycle: from discovery, through development, commercialisation and beyond. 
  11. 11. TCS CLIN-E2E SOFTWARE <ul><li>TCS’ mission reflects Tata Group’s long standing commitment to providing excellence to help customers </li></ul><ul><li>achieve their business objectives by providing innovative, best-in-class consulting, IT solutions and services. </li></ul><ul><li>TCS’ vision is to be one of the top 10 global companies by the year 2010. </li></ul><ul><li>TCS’ Life Sciences & Healthcare (LSHC) Industry Practice, with an experienced team of over 3,500 </li></ul><ul><li>professionals, provides IT services and solutions to companies in medical research, pharmaceutical, healthcare </li></ul><ul><li>and medical devices industries. </li></ul><ul><li>TCS meets client challenges such as rising R&D costs, pipeline failures, patent expiry, compliance with </li></ul><ul><li>quality standards, etc. by developing a comprehensive strategy for accelerated drug development, reduced </li></ul><ul><li>clinical trial costs and integrated care delivery networks. </li></ul>About Company <ul><li>Established in 1968, Tata Consultancy Services has grown to its current position as the largest IT services firm in Asia. TCS is a preferred alliance partner of most leading IT product and platform companies, including Oracle, SAP, Microsoft, IBM and HP, among others. </li></ul>
  12. 12. TCS CLIN-E2E SOFTWARE <ul><li>Key Features: </li></ul><ul><li>Protocol Driven – Ensures in-built validation across the entire Data Management Process. </li></ul><ul><li>Flexible – Handles both paper-based trials and EDC (electronic data capture). </li></ul><ul><li>Universal Clinical Repository – Allows creation of CRF Repository and Study Templates, that can be </li></ul><ul><li>reused, thereby reducing the study time. </li></ul><ul><li>Query Management Workflow – Role-based query management workflow for data modification and </li></ul><ul><li>correction. </li></ul><ul><li>Standard Interface – Readily available interface to integrate with industry standard products like </li></ul><ul><li>Documentum, MedDRA, SAS and other third-party enterprise systems. </li></ul><ul><li>Regulatory Compliance – Compliant with 21 CFR Part 11, GCP. </li></ul><ul><li>Data Standards based – Meets the CDISC ODM and SDTM Standards. </li></ul>About Software The Clinical Trial Management Solution Clin-e2eTM addresses all four phases of clinical trials. A secure online environment captures electronic data and integrates sites and labs with sponsors. Pharmaceutical companies are able to create customised Case Report Forms (CRF). The generation of CRFs allows effective investigation of clinical data This enables monitoring of global trial sites, reduces time and cost of clinical trials, and ensures compliance with global frameworks.
  13. 13. COGNOS 8 BUSINESS INTELLIGENCE SOFTWARE <ul><li>Cognos’ client list, which today exceeds 23,000, also includes a broad range of life science and health care companies. </li></ul><ul><li>Early adopters of technology have implemented systems like EDC and CTMS that are point solutions and offer limited decision support. By accurately measuring speed to market, timeliness in development, data quality, and the performance of personnel and partners, Cognos makes management of clinical data simpler and hence, improves performance. </li></ul><ul><li>As one of the world’s leading providers of business performance software, Cognos is the clinical data management solution of choice for 24 of the world’s top 30 pharmaceutical firms. </li></ul><ul><li>In addition to this, IBM Cognos 8 Go! Mobile provides users with access to timely, secure, and personalised information on their mobile devices and operating systems, including Blackberry, Windows mobile and Symbian60 wireless. </li></ul>About Company
  14. 14. COGNOS 8 BUSINESS INTELLIGENCE SOFTWARE About Software IBM Cognos 8 Business Intelligence delivers the complete range of BI capabilities on a single, service-oriented architecture (SOA). The Business Intelligence Capabilities include: <ul><li>Reporting </li></ul><ul><li>Analysis </li></ul><ul><li>Dashboards & Scorecards </li></ul><ul><li>Multi-lingual reporting in multiple export formats such as Excel, PDF, XML, HTML, and CSV. </li></ul><ul><li>Structure data and reporting to comply with HIPAA, CFR 21, PDMA, state marketing regulations, and FDA NDA processes. </li></ul><ul><li>Improve resource allocation through analysis of performance data. </li></ul><ul><li>Carry analysing and reporting on clinical performance information. </li></ul><ul><li>Processing and summarising of data in the application layer and returning of results only at a summary level. </li></ul><ul><li>Monitor performance against key milestones such as investigator selection, IRBs or </li></ul><ul><li>Institutional Review Boards, site initiations, enrollment, drug shipments, and availability at national, regional, territory and product levels using dashboards and scorecards. </li></ul>
  15. 15. SYMETRIC SOFTWARE <ul><li>The SyMetric software has been carefully crafted over 20 years of direct experience in all Clinical Data Management environments, including Pharmaceutical, Biotechnology, and CRO companies. </li></ul><ul><li>The company advocates the SyMetric System with the punch line as “Software designed and built for clinical data management by clinical data management professionals”. </li></ul><ul><li>Additionally, SyMetric Sciences offers a secure web-enabled database server system for efficient Internet data collection for clinical trials including pharmaco-economic, worldwide patient diaries, or Quality of Life studies using web forms (e-CRF). </li></ul><ul><li>SyMetric Sciences enjoys membership to a number of reputed organisations, viz. </li></ul><ul><li>DIA (Drug Information Association) </li></ul><ul><li>The Society for Clinical Trials </li></ul><ul><li>The American Statistical Association </li></ul><ul><li>The International Biometric Society </li></ul><ul><li>The Regulatory Affairs Professionals Society </li></ul><ul><li>The Association for Clinical Data Management </li></ul>About Company <ul><li>SyMetric Sciences licenses a comprehensive, cost-effective clinical data management system for clinical trial data collection and management which fully complies with international regulatory standards and has a worldwide client base . </li></ul>
  16. 16. SYMETRIC SOFTWARE <ul><li>The software is loaded with the following functionalities: </li></ul><ul><li>All processes driven by a fully integrated extended data dictionary. </li></ul><ul><li>Ergonomic designed for efficient data entry with full discrepancy management. </li></ul><ul><li>Enter all data &quot;as seen&quot;. </li></ul><ul><li>Full classification of missing data using special codes. </li></ul><ul><li>Support for near-time interactive double data entry verification. </li></ul><ul><li>Built-in CRF Tracking functions and Query Management. </li></ul><ul><li>Complete electronic Help and Documentation Reference Manual. </li></ul><ul><li>Designed for rapid prototype application development. </li></ul><ul><li>Expanded Audit Trail, comprehensive data quality control and security. </li></ul><ul><li>Full set of review and reporting tools. </li></ul><ul><li>PC-based, intuitive, fully &quot;GUI&quot; user interface. </li></ul><ul><li>Integrated imaging capabilities for viewing CRF images. </li></ul><ul><li>Highly modular and compressed executable modules minimizing disk storage. </li></ul><ul><li>Highly flexible and configurable on-demand, export options to ASCII, HTML, DBF, and SAS datasets. </li></ul><ul><li>Fully software validated for compliance with regulated environments and &quot;Best Industry Norms&quot; . </li></ul>About Software The software represents a high level of maturity and a rich understanding of the day-to-day requirements for efficient and effective clinical data management workflow processes - from database setup, to data quality controls, and final export.
  17. 17. AKAZA’S OPENCLINICA SOFTWARE <ul><li>In 2005, Akaza Research released OpenClinica, which has since been adopted at over 50 leading clinical </li></ul><ul><li>research institutions worldwide, including biopharma companies, government organisations, contract research organisations, and academic medical centers. </li></ul><ul><li>The company philosophy is to develop solutions based upon open standards and architectures, with the principles of transparency and extensibility. </li></ul><ul><li>Through leadership role in the field of clinical informatics and value added products and services for OpenClinica adopters, Akaza Research offers an efficient, flexible, and low-cost way to manage clinical research. </li></ul><ul><li>It is, perhaps, to further the same aim that as an open source product, the OpenClinica source code is freely available for download at </li></ul>About Company <ul><li>Akaza Research provides open informatics solutions that address the needs of institutions engaged in clinical research. The company was created with the goal of promoting shared tools, repositories, and open standards for public research. </li></ul>
  18. 18. <ul><li>Some key features of OpenClinica include: </li></ul><ul><li>Organisation of clinical research by study protocol and site, each with its own set of authorised users, subjects, study event definitions, and CRFs. </li></ul><ul><li>Support for sharing resources across studies in a secure and transparent manner. </li></ul><ul><li>Dynamic generation of web-based CRFs and validation logic specified in portable Excel templates. </li></ul><ul><li>Management of longitudinal data for complex and recurring patient visits. </li></ul><ul><li>Data import/export tools for migration of clinical datasets in excel spreadsheets and local databases </li></ul><ul><li>Extensive interfaces for data query and retrieval, across subjects, time, and clinical parameters, with dataset export in common statistical analysis formats. </li></ul><ul><li>Compliance with HIPAA privacy and security guidelines including use of study-specific user roles and privileges to monitor access and changes by users. </li></ul><ul><li>A robust and scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including PostgreSQL (open source) and Oracle 10G, to support the needs of the clinical research enterprise. </li></ul>AKAZA’S OPENCLINICA SOFTWARE About Software OpenClinica is a free, web-based open source clinical trial software platform for Electronic Data Capture (EDC) clinical data management in clinical research. Its modular architecture and transparent, collaborative development model offer outstanding flexibility while supporting a robust, enterprise-quality solution.
  19. 19. <ul><li>SigmaSoft International was founded in the year 1998.Since then, the company has come a long way and has met the challenge of developing an easy to learn, user-friendly and affordable data management software that brings efficiency to the entire data management process, while being fully compliant with 21 CFR Part II. </li></ul><ul><li>The company boasts of a highly skilled development team that has extensive experience in both software development and clinical research. </li></ul><ul><li>This clinical data management system, so developed, is befitting for both small clinical trials with only a few patients and large clinical trials with thousands of patients. </li></ul><ul><li>The client list of the company includes: </li></ul><ul><li>The Swiss Tropical Institute; and </li></ul><ul><li>The Northwestern University, </li></ul><ul><li>both having selected DMSys as their data management software for clinical trials. </li></ul>SIGMASOFT’S DMSYS SOFTWARE About Company <ul><li>SigmaSoft International is a global provider of data management software for clinical trials. The company provides high quality data management solutions complemented by the best possible service and support, all at an affordable cost. </li></ul>
  20. 20. <ul><li>Key features include: </li></ul><ul><li>A price structure that keeps data management software affordable. </li></ul><ul><li>System fully validated and compliant with FDA and European regulations and GCP guidelines. </li></ul><ul><li>Easy study setup with built-in data checking functions, convenient user interface and minimum programming. </li></ul><ul><li>Easy data entry screen setup. </li></ul><ul><li>Integrated shortcuts allow one to copy Forms, data entry screens, logic checks and all other study structure from Form to Form in the same study or from one study to another - a major time saver. </li></ul><ul><li>Flexible data entry options and data verification. </li></ul><ul><li>High-speed platform provides for rapid data cleaning. </li></ul><ul><li>Sophisticated error management function. </li></ul><ul><li>Robust query management capabilities. </li></ul><ul><li>Flexible report writing capabilities with over 30 built-in reports. </li></ul><ul><li>Easy data import/export from Excel, dBase files and SAS (ASCII) Excellent security measures to manage access to software functions and study data for each individual user. </li></ul><ul><li>User Validation Package designed to support validation process. </li></ul><ul><li>High quality and timely training and support services. </li></ul>SIGMASOFT’S DMSYS SOFTWARE About Software <ul><li>DMSys is a powerful but easy to use data management system for clinical trials. Its design is based on 3 guiding principles: </li></ul><ul><li>GCP and regulatory compliance </li></ul><ul><li>User friendliness and efficient </li></ul><ul><li>Affordability </li></ul>
  21. 21. <ul><li>The premise of the application was originally conceptualised by a local oncologist involved in a collaborative study who needed the following: </li></ul><ul><li>Pedigrees and data to be intimately linked together and updated simultaneously; </li></ul><ul><li>Pedigrees to be easy to construct and easily modified; </li></ul><ul><li>A fully functional database allowing for the end-user to customise it for any hereditary study, without requiring database programming skills. </li></ul><ul><li>Ability for multiple users to access pedigrees and data for collaboration. </li></ul><ul><li>These needs resulted in what is still today one of the most comprehensive pedigree and clinical data management softwares available today. </li></ul><ul><li>  In addition to Progeny Clinical, which is the ideal clinical data management software to track family history data, Progeny Software provides Progeny Lab for full genotype management and has lately introduced LIMS software, providing the ability to manage sample inventory and customise workflows for any specific environment. </li></ul><ul><li>Also, Progeny provides old-fashioned, comprehensive, toll-free customer support. </li></ul>PROGENY CLINICAL SOFTWARE About Company <ul><li>Progeny Software, LLC was established in 1996 and presented the first version of the software at the ASHG (American Society for Human Genetics) Conference. Since its introduction in 1996, Progeny now counts customers in over 60 countries. </li></ul>
  22. 22. <ul><li>Pedigree, Individual and Sample Management </li></ul><ul><li>Importing/exporting data </li></ul><ul><li>Import and export data easily </li></ul><ul><li>Import pedigrees </li></ul><ul><li>Core database functionality </li></ul>About Software PROGENY CLINICAL SOFTWARE Progeny Clinical is the ideal clinical data management software to track family history data. Since 1996, Progeny has been providing research institutions and clinical genetic services worldwide the ability to track patient history data. Key features include: Manage Samples Create Sub-Pedigrees Draw and Manage Pedigrees Quickly Query and Highlight Pedigree Individuals Assign Samples to Individuals Display Haplotypes Icon and Subtext Legends Custom Display Pedigrees Manage Individuals User and Class Based Security Data Validation Create Custom Reports Enter, Search and Query Data Create and Design Custom Data Entry Forms Multiple Database Connections Create Unlimited Fields and Design Multiple Databases Client and/or Browser Based Installation Integration with Lab and LIMS
  23. 23. ABOUT BII - PROGRAMS OFFERED Established in 2002, Bioinformatics Institute of India (BII), an initiative of Confrere Education Society, is a non profit making educational, R&D and development centre. It stands as a reputed and pioneering institution for imparting quality education and training in the different emerging disciplines of Life Sciences. BII is today recognized across the globe as a premier institution offering programs in the diverse areas of Bioinformatics, Clinical Trials, Pharma Regulatory affairs, Pharma Quality Assurance and Control, Drug Design and Patenting, IPR and Biotechnology etc. SUBJECT AREAS OF SPECIALISATION CLINICAL TRIALS DRUG DESIGN AND PATENTING INTELLECTUAL PROPERTY RIGHTS BIOTECHNOLOGY PHARMA QUALITY ASSURANCE AND CONTROL BIOINFORMATICS PHARMA REGULATORY AFFAIRS
  24. 24. ABOUT BII – PROGRAMS OFFERED These training programs are offered through various modes including distance participation, e-learning, classroom, etc. Workshops, Corporate trainings, etc. are also conducted from time to time. The quarterly journal Bioinformatics – Trends is one of its kind journal in India. The institute also supplies multimedia and corporate training kits to governments, private bodies and individuals in its diverse areas of expertise. MODES OF TRAINING PROGRAMS DISTANCE PARTICIPATION CLASSROOM PROGRAMS CORPORATE TRAININGS PUBLICATIONS E-LEARNING PROGRAMS WORKSHOPS PROJECTS/TRAININGS
  25. 25. BII’s PROGRAMS IN CLINICAL TRIALS INDUSTRY PROGRAM IN CLINICAL TRIALS, RESEARCH & ADMINISTRATION (12 MONTHS DISTANCE PARTICIPATION PROGRAM) The prime objective of this program is to provide quality inputs in the area of Clinical Trial, Research & Administration, to working professionals and individuals who have completed their education and are willing to contribute to this area. It also aims to develop documentation/research writing expertise in the Clinical Trial, Research and Administration sector. Promotion of spread, enhancement and sharing of knowledge in this field is of great importance. The core areas of studies are comprised in the 8-Modules Course Structure: Module I- Clinical Trials Module II- Contract Research Module III- Contract Research and Clinical Trial Environment Module IV- ICH -GCP Guidelines - International Conference of Harmonisation Module V- ICMR -Guidelines on Biomedical Research on Human Subjects Module VI- SCHEDULE Y Module VII- Biostatistics Module VIII- Research Study Program Deliverables include : Training Kits comprising of Reference Materials and Free Lecture CDs, Support via Internet, Email & Telephone and Information exchange via BII Blog. Graduates/Final year students from any discipline can apply by downloading form and submitting it with BII Program Participation Fee of Rs.10,000(exam fee exclusive).
  26. 26. BII’s PROGRAMS IN CLINICAL TRIALS ADVANCE PROGRAM IN CLINICAL TRIALS, RESEARCH AND DATA MANAGEMENT (12 MONTHS CLASSROOM WEEKEND PROGRAM) The main objective of the course is to provide students with a theoretical and practical understanding of the issues, including ethical issues, involved in the design, conduct, analysis and interpretation of clinical trials. <ul><li>After completion of the course, the participant would be able to: </li></ul><ul><li>Have better understanding of Good Clinical Practice (GCP) and Standard Operating Procedures for Clinical Research. </li></ul><ul><li>Participate in design, conduct and management of Global Clinical Trials, conducted at multicentric sites in India and Overseas. </li></ul><ul><li>Contribute more effectively in their profession - pharmaceutical/Bio pharmaceutical companies in drug development. </li></ul><ul><li>CRO's offering clinical research and clinical data management services, in BIO-IT Life science, Industry or Academic Research institutions. </li></ul><ul><li>As a clinical investigator at hospitals, medical sites conducting trials on subjects. </li></ul><ul><li>Handle regulatory affairs as per the changes in the statutory laws. </li></ul><ul><li>The core areas of studies are comprised in the 7-Modules Course Structure: </li></ul><ul><li>Module-I Clinical Trials and Clinical Trials Environment </li></ul><ul><li>Module-II Statistics for Clinical Trials </li></ul>
  27. 27. BII’s PROGRAMS IN CLINICAL TRIALS <ul><li>ADVANCE PROGRAM IN CLINICAL TRIALS, RESEARCH AND DATA MANAGEMENT </li></ul><ul><li>(12 MONTHS CLASSROOM WEEKEND PROGRAM) </li></ul><ul><li>Module-III Clinical Data Management </li></ul><ul><li>Module-IV Contract Research </li></ul><ul><li>Module-V Regulatory Affairs, Good Clinical Practices, Pharmacovigilance and Ethics </li></ul><ul><li>Module-VI Practical Medical Writing and Documentation </li></ul><ul><li>Module-VII Research Study </li></ul><ul><li>The methodology for the program delivery would be: </li></ul><ul><li>Delivery of the lectures by the technically expertise Faculty. </li></ul><ul><li>Guest Faculty from industry and academia would deliver the lectures. </li></ul><ul><li>Along with the theoretical knowledge student would also get a chance to have a practical oriented understanding of the subject e.g. role of computers in Clinical Trials </li></ul><ul><li>E-learning platform via Moodle would also be employed for the classes. </li></ul><ul><li>Students would also be taken for Industrial and Hospitals’ visits to have an overview of the entire Clinical trial process. </li></ul><ul><li>Eligibility: The course is most suitable for doctors, medical professionals and pharmacists, although graduates/final year students from any discipline may also apply by submitting the application form with necessary fees and attachments. </li></ul>
  28. 28. BII’s PROGRAMS IN CLINICAL TRIALS ONLINE PROGRAM IN CLINICAL TRIALS & RESEARCH (3 MONTHS e-LEARNING PROGRAM) The prime objective of this program is to help to understand basics of clinical trials. It has been specifically designed to answer scientific questions and to find better ways to treat individuals with a specific disease. The core areas of studies are comprised as follows: Teaching and learning methods include content documents, directed reading, a range of on-line systems of information retrieval, literature reviews and moderated on-line seminars. Graduates in any discipline can apply . Highly motivated students pursuing graduation /Diplomas courses in Pharmaceutical science/chemistry and allied areas are also eligible . Course fee is INR 5000. Bioethics Clinical Trial Regulatory Affairs Clinical Trial Business Environment Clinical Trial Delivery Model Clinical Trial Team Clinical Trial Informatics Design of Experiments Bioavailability Studies Clinical Trial Statistics Patient Recruitment Good Clinical Trial Practices Features of Clinical Trials Basics of Clinical Trials & Clinical Research
  29. 29. BII’s PROGRAMS IN CLINICAL TRIALS CLINICAL TRIALS CORPORATE TRAINING KIT The main objective of the course is to provide individuals with a complete knowledge of clinical trials from study start-up to closure. It covers the whole spectra of issues critical to the successful operation of clinical trials-its design, responsibilities of the study team, safety measures, the regulatory framework that governs clinical trials and the financial aspect of it. It also gives an overview of the various soft wares used in clinical trials. The core areas of studies are comprised as follows: Program Deliverables include : An Educational VCD providing Lecture sessions, an Audio enabled PowerPoint Presentation of Clinical Trials, Electronic Self Evaluation Workbook for Self assessment and practice, a Book on Clinical Trials Published by BII & User manual. The kit is beneficial to pharmaceutical companies-established and de novo, research or health organizations involved in Clinical Trial processes, govt. organisations, NGOs, motivated students/individuals doing pharmaceutical studies,etc. and costs Rs.4000/-. Clinical Trial Business Environment Clinical Trial Delivery Model Bioavailability Studies Adverse Event Reporting Audit of Clinical Trial Patient Recruitment Concepts in Clinical Trials Initiation of Clinical Trials Bioethics Clinical Trial Regulatory Affairs Conduct of Clinical Trial Design of Experiments Clinical Trial Statistics Clinical Trial informatics Good Clinical Trial Practices Clinical Trial Team Introduction to Clinical Trials
  30. 30. THANK YOU For Further Details & Enquiries, Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: [email_address] Visit: