Infoset builds software and services to advantage business operations and improve patient s life

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1 Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data Analytics Patient Registries Cloud computing

2 Trusted IT advisor for Life Sciences Infoset is a specialized IT firm focusing on the health sector in Greece and internationally. Based on the vast experience of its people and strong business know-how, Infoset delivers cloud based clinical development solutions and tailor made services in order to cover specialized needs of pharmaceuticals, biotechnology, medical devices and diagnostics companies, academic institutions, medical centers, contract research organizations and other entities. The expertise and its proven success record in delivering important projects for multinational customers, along with the dedication to achieving the highest quality and customer satisfaction, places Infoset among top partners that can deliver direct benefits for its customers. 1

3 Profile About Us We trace our beginnings back to 2000 with the thesis of our founder, Fotis Stathopoulos, in National Technical University of Athens about an on-line questionnaire system for the evaluation of subjects like students, employees or patients. About 10 years later, Infoset is founded in order to combine latest technology trends with medical needs focusing on the clinical research sector. Nowadays the same entrepreneurial spirit and passion for innovation is transforming clinical development and health science sector through a widespread partner and client network. Mission Infoset mission is to advantage life science operations and every day patient life by applying intuitive information technology solutions. Clients & Partners We are proud to be partners of some of the biggest multinational pharmaceutical industries and top contract research organizations who use our solutions and trust their data and operations on us. Our Work We recognize that health sector needs the highest quality in software and services to operate within a strict regulatory environment. That s why our employees are trained on GCP and other standards to responsibly develop the most efficient, easy to use and validated solutions. Research & Development Dedication to R&D and commitment to technology innovation is at the foundation of the company s business strategy. Infoset maintains in-house the rapid development of high-quality, advanced software systems researching and constantly introducing new methods and ideas. Infoset annually invests 10%-20% of its revenue in R&D programs. 2

4 Our Services Infoset offers Certified Clinical Data Management with i-cdms, one of the most sophisticated yet easy to use EDCs Infoset offers a set of innovative solutions and exceptional services answering the needs of modern management of clinical research with top notch quality services. Building on our innovative platform (i-cdms), we support and enable pharmaceutical, medical device companies and research organizations to automate their entire clinical development process and fundamentally transform the way clinical trial data is collected, analyzed and managed. Our services cover the complete range of activities from CRF design, data capture and data validation to modeling and executive reporting through standardized web enabled platforms and tailor-made analytical environments. Through our services organizations enjoy an effective and more predictable methodology to streamline trials processes, reduce cycle times, decrease expenditures and gain earlier and safer access to the correct results. Moreover the holistic view of the full study cycle through i-cdms reports and interactive charts offers better control and efficient decision support. We continue to improve best practices and technology tools to support clinical studies, so our partners can focus on the important areas of the research. Audit trails and traceability Collaborative Increase in operational efficiency Secure data Exchange Timely, Accurate, Authoritative, Conformed and On demand data Clinical Data Management Data Integration Transformation and Migration Discrepancy management Metadata Driven CRF/eCRF Data access and profiling Infoset got certified for Clinical Data Management services from SCDM in January

5 i-cdms i-cdms Features i-cdms is an innovative cloud based system offering a complete set of features for streamlining trial monitoring and data entry with e-crf, automated edit checks and queries resolution, patient and site reporting, real time notifications and reminders and others that are accessible from all trial participants according to their roles. i-cdms has been built with the latest technology tools and state of art user interface consisting a fully qualified EDC for supporting all types of trials. Today i-cdms is the #1 choice of many sponsors due to its easiness of use, its quick adoption from the investigators and the wide advantages it offers in monitoring and control of clinical trials. i-cdms has passed full system validation in accordance with international regulations and complies to 21 CRF part 11 and HIPAA requirements. i-cdms is accessible via the internet without any other special requirement or installation needed at the site. Electronic Data Capture (ecrf) 21 CFR Part 11 Compliance HIPAA Compliant Patient Database Double Data Entry Scheduling & Study Planning Randomization Blinding Patient Recorded Outcomes Safety Reports (DSUR, PSUR etc) Risk based Monitoring SDV CDISC Import / Export Cost Planning & Financial Management Accounting Integration Enrollment & Recruitment Management Discrepancies Tracking Laboratory data & IT Systems Integration Document Management Electronic signatures 4

6 Data Management Plan (DMP) Key Facts DMP defines the strategy and decisions made in relation to data management activities of the clinical study, including standards, processes, responsibilities and timelines. It also describes all data management deliverables and responsibilities of study personnel. DMP is an essential document to ensure quality, accuracy of data, compliance with GCP guidelines and reduce any associated risk. DMP is tailor made per study from Infoset according to the sponsor s requirements or templates. Partners among top international pharmaceuticals and CROs Over 25 successful clinical trials in a variety therapeutic categories (over patients) First to introduce e-crf & EDC for local trials First to introduce Study Support Center for real time reporting and monitoring of study s progress Cloud infrastructure in cooperation with Microsoft (Azure Cloud) Risk based monitoring Real-time sms & notifications Highly positive feedback from investigators, over 90% would recommend i-cdms for their next trial. Minimum user issues, only 10% of sites need to call helpdesk for any reason. CDISC, SDTM and ODM standards (DMP) CRF Design & system validation We follow CDISC widely recognized standards for design, collection and exchange of clinical data and submission to clinical authorities. CDISC open data standards have been developed collaboratively by global volunteers to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting. We offer professional CRF design according to study protocol and endpoints and also data field optimization for EDC which enables tracing and monitoring of CRFs, sites and patients. Also CRF annotation is applied both for electronic and paper based trials. System validation is processed with specialized methodology compliant with 21 CRF part 11 and GCP. 5

7 Data Management Committee & Study Support Center Infoset provides a DM committee for all types of clinical trials. All trial participants enjoy 24/7 support by phone, or online via i-cdms. The support can be passive (incoming requests) or active (periodic check of users convenience), depending on the complexity, timelines and characteristics of each study and we ensure the feasibility of study s milestones, the quick resolution of issues and the accuracy of the results. Queries Generation & DCF Submission CARDIOVASCULAR OSTEOPOROSIS IMMUNOLOGY ORTHOPAEDICS INFECTIOUS DISEASES PULMONOLOGY CNS PSYCHIATRY DERMATOLOGY RESPIRATORY DIABETES Indicative therapeutic areas list METABOLIC DISEASES RHEUMATOLOGY ENDOCRINOLOGY NEPHROLOGY SURGERY NEUROLOGY UROLOGY GASTROENTEROLOGY ONCOLOGY VACCINES OPHTHALMOLOGY Infoset provides the complete service of data validation based on predefined criteria (protocol or logical violations, missing fields and others). Data Clarification Forms (DCFs) are generated electronically and can be resolved by the investigator on i-cdms. All queries are tracked and identified with Query Lifecycle Statistics (QLS) metadata. Data managers, monitors, and CRAs know in real time the exact status of queries and can follow the the audit trail of the changes. Training Infoset provides full training on i-cdms on site or remotely with online presentations according to sponsor special requirements. Training videos and documentation material are also available in i-cdms for self-trained purposes or reference during the study. PhV handling & Safety Reports Special process is established for reconciliation and handling of adverse effects. Infoset ensures that proper SAE form has been submitted electronically to the sponsor s PV or other authorities through notification report s with integrated confirmation. In addition study progress is monitored at safety level by reports that describe the full status down to the patient level. Through i-cdms all kind of safety reports (DSUR, PSUR etc.) can be provided on demand or periodically. 6

8 Statistical analysis Our team of statisticians with world-wide experience is dedicated to delivering quality services across a wide range of therapeutic areas with the latest tools and methodologies. Infoset provides online and real time statistical tools to predict results, manage risk and control study progress with customized and easily generated interim reports. Interactive real time six-dimensions chart Cloud computing Infoset can build native cloud based applications utilizing all the advantages and flexibility it offers for the health industry. Our systems have been migrated fully to cloud infrastructure (Azure) from May 2014 in cooperation with Microsoft allowing our services to support any number of users and clinical trials anywhere in the world without any degradation in performance or other limitations. Special preparation has been taken to fulfil HIPAA compliance and 21 CRF part 11 requirements. The cloud also enabled the easier use of mobile devices for all our solutions. e-health Solutions Infoset has built a variety of customized cloud application for the health industry like platforms for patient support programs, patient registries and mobile e-health applications. Platform for Patient Support Programs. Manages program s patient s details and online registrations. Supports notifications, training schedule and supplies management, interactive charts and automated reports to sponsors and PSP personnel. Also includes lists of health care professionals (IMS) and regional statistics. Medication Adherence application. Enables patients to control medication, being monitored in real time by the doctor, receive notifications and achieve adherence through gamification principles. Easily accessible from mobile phone or web. Patient Registries. Collects patient data for the scientific assessment of patient outcomes in medical centers, hospitals and other. 7

9 Why Us At Infoset we have a mission to build intuitive IT solutions according to future technology trends and current patient s needs. We strongly believe that enabling life science companies to operate more efficiently will improve patient s life. Know How We have a strong IT background and deep medical cognition enabling us to solve life sciences problems with high end technology. We know our clients and their business and what we mutually want to achieve. Service We focus to our client s needs, though a spirit of excellence and often exceeding the core requirements of our industry. Innovation We have a constant innovation program in place allowing us to generate new ideas and solutions for our client s problems, even before we are asked to. Trust We value our clients and we offer our maximum to bring the best results. 8

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