XClinical Software & Services Fast - Flexible - Focused

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1 Fact Sheets

2 XClinical Software & Services Fast - Flexible - Focused XClinical offers an integrated range of software products for CROs, pharmaceutical, medical device and biopharmaceutical companies. Our products cover the lifecycle and complete data management process of a clinical trial. Based on a core CDISC EDC engine the software suite combines various integrated modules optimally supporting clinical trial processes such EDC, Study Build (Composer), IWRS (Randomization), WebPRO (Marvin for patients), CTMS (Trial Manager), DDE/CDM (Paper), Coding (Coder). In addition to the solutions listed below, we offer ETL mapping (Tabulator), Data Upload, Ad-Hoc Reporting (upcoming), Risk-based Monitoring, Alerts, clickable images, etc. 2

3 About Us XClinical is a medium-sized company fully dedicated to developing software to support the clinical development of drugs and medical products. The company was founded in Munich, Germany in 2002 with a vision to build a new EDC system leveraging CDISC standards to accelerate the database build and reduce data management programming efforts. The company has grown at an average annual growth rate between 10-25% each year since its inception. Customer base has grown to over 65 clients including more than 30 CROs that use Marvin independently of XClinical. Over the last 5 years we have opened offices in New Jersey, US, Basel, Switzerland. Through partnerships we are also represented in Nantes, France and Tokyo, Japan. We are an active member of the CDISC organization because we are convinced that the widespread use of this standard for data interchange, data submission and archiving facilitates the efficient use of e-trial technology and processes. Marvin was one of the first products to be certified to the CDISC ODM standard. Products for an End-To-End Solution 3

4 XClinical s eclinical software encompasses two main products: Marvin (data capture system) and Composer (ecrf design and tabulation software). Built on the same platform the Marvin suite contains numerous modules all delivered in a Software-as-a-Service model. Accessible from any browser, Marvin supports all global languages. The main benefit of Marvin compared to our competitors products is the fact that Marvin is built utilizing the CDISC standard from the ground up and fully utilizes the related advantages. We offer an integrated range of modules that cover the entire lifecycle and complete data management process of a clinical trial; the CDISC organization calls this the end-to-end process. Thanks to the consistent use of various CDISC standards from CRF design to data collection, data cleaning and data export to tabulation, analysis and archiving, Marvin provides maximum benefit in the form of cost and time savings, and improves quality by avoiding data conversion errors. Marvin was one of the first two EDC software products to be officially certified for the ODM standard by the CDISC organization. Corporate Experience and Expertise First trial conducted with Marvin: 2003 Number of trials to date: over 550 trials in more than 60 countries Types of trials: Phase I-IV pharmaceutical trials Medical device trials Non-interventional studies, Registries Number of subjects: Over 200,000 Technology Transfer: Regulatory compliance: We enable our customers to set up and manage their own clinical trials independently of XClinical. Compliance with all relevant regulatory requirements of the FDA and EMA, in particular 21 CFR Part 11 and GCP. ODM certified by CDISC: Since

5 Feature Highlights The following characteristics of the XClinical software suite stand out: Automatic setup of ecrfs and data validation plan by uploading CDISC metadata Multi-language dynamic ecrfs usable in all browsers without any additional software installation Double Data Entry (DDE) CDISC data import and export Source data verification Dynamic online reports, embedded Business Intelligence and Reporting Tool Multi-trial portal with single sign-on Central web-based randomization and drug accountability Administrative forms for monitoring reports and payment information Cross-trial user, site and role management Patient data transfer from registries to clinical trials Patient-reported outcome (epro) via web diary Binary data input such as X-rays, images, ECGs4 Out of the box standardized ODM database Marvin Modules 1. Composer - Study Set-up - Tabulation 2. Marvin for patients (WebPRO) 3. Risk-based Monitoring 4. Randomization (IWRS) and Logistics 5. Coder (Integrated Coding Architecture) 6. Marvin for Paper (DDE/CDM) 7. CTMS Clinical Trial Management System 5

6 1. Composer Consistency & Acceleration in ecrf Design The XClinical Composer provides an intuitive graphical user interface for study setup including ecrf design and data validation plan. As a replacement for MS Word and Excel during the preparation of a clinical trial, the Composer generates considerable time and cost savings. Through the use of XClinical s Composer, the ecrf design, annotated CRF, data validation plan, visit matrix, database specs and other core documents are automatically derived from a single, central, XML-based set of metadata. This ensures that all necessary documents are automatically consistent with each other, thereby eliminating the manual transcription effort required to maintain different documents and increasing quality by avoiding inherent error risks. Data managers can utilize the Composer to build and use an item, form, study etc. or to utilize the ecrf library, which enables them to effectively and consistently re-use existing items and CRF definitions. In this way, the tool automatically ensures compliance with the international CDISC ODM standard format, enabling the CRF and database design to be exchanged with different systems and organizations, e.g. between sponsors and CROs. In combination with an EDC/CDM system that can import CDISC ODM metadata, the Composer supports the automatic setup of an EDC database. With an EDC/CDM system that does not have this capability, the Composer still provides the best possible, unambiguous specification of the CRF, database and data validation plan, this guarantees the most efficient communication between different teams and organizations. Active guidance for CDISC Standards in order to support max. compatibility Composer highlights Edit checks are designed within Composer, a graphical point-and-click/drag-and-drop tool; no programming knowledge is required. Library functionality is also included allowing the user to copy and paste everything from single questions to entire case books for re-use in another study. Since Composer is so flexible, making changes to a current study is simple and automatically includes version control. Depending on the size of the change, a tested mid-study change can be implemented in a few days. Mid-study protocol amendments can be activated on a site by site basis or based on different criteria; for all patients or for new patients or old patients only. 6

7 Key features are: Intuitive graphical interface for quick and easy study setup Smart search & copy functionality to create and use a library Rule and formula editor enables the easy and unambiguous definition of a comprehensive data validation plan without the necessity of programming knowledge Automatic output of the annotated CRF, visit matrix and data validation plan in tabular form Easy setup and management of amendments Validated, CDISC ODM-compliant storage and export of the CRF design Can be used in combination with any EDC system Operates offline (Microsoft Windows) and online (any browser) Imports third-party vendor extensions without any modifications CDISC XML-based Data Tabulation The tabulator an integral part of the Composer. It is an ETL solution (Extraction-Transformation- Loading), which works independently of databases because it is built on the CDISC define.xml standard. It enables users to create CDISC SDTM-compliant datasets ready for submission to the authorities or for reporting purposes. Data managers can define mapping instructions for converting CDISC ODM data into CDISC SDTM or other partially de-normalized datasets. Mapping instructions can contain directions for selection, copying or complex data conversion. The tabulator can be used independently of the controlled CDISC terminology or to convert legacy data into the CDISC standard. The tabulator is an essential tool to leverage the full power of the CDISC end-to-end approach. It allows the consistent use of a unique set of XML-based metadata from CRF Design to data submission. Key features are: Define.xml-based mapping of EDC/CDM datasets and SDTM datasets Intuitive graphical user interface Copy & paste of value-level metadata between CRF and SDTM datasets Easy setup of suppqual domains Creates define.xml including links to the annotated CRF Independent from SAS 7

8 2. Marvin for patients (WebPRO) With more and more studies requiring Patient Reported Outcome over the last few years, Marvin provides a feature called WebPRO as an integrated module. Key features are: Integrated part of Marvin Simplified user interface for optimal user acceptance Configurable visibility of WebPRO data to other users such as the investigator Simple account creation Inline reports Alerts via can be set up Date dependent visibility e.g. the user may enter data only during a certain period or to disallow modification of previously entered data Clickable images and scales Qualified identifying data handling e.g. telephone number Automatic password forgotten workflow Language-specific simplified question labelling for patients 3. Risk-Based Monitoring The Marvin EDC system supports the source data verification (SDV) process by distinguishing between different levels of expected data validity for each specific study center. By setting up a detailed Monitoring Plan containing risk levels and customizable verification rules the system is ideally adaptable to the site and data handling workflow. This Monitoring Plan may also be changed and amended at any time to ensure a maximum of flexibility in a fast-changing clinical study environment. The Monitoring Plan, combined with the Sponsor s identification of critical data and with a close control of entered data by automated plausibility checks is an effective and cost efficient way to guarantee the safety of subjects and the quality and integrity of clinical trial data. 8

9 4. Randomization and Logistics The Randomization System is an IWRS (Interactive Web Response System) built into Marvin; therefore no interface to an external system is required. The system supports open or double-blind, multi-strata, multi-group randomization based on a block list or a widely configurable minimization algorithm. The block based randomization can be set up by uploading a randomization list and a material list via the web interface. The randomization list can include blocks of any size linked to an unlimited number of therapy groups and stratification parameters. Figure 1 :randomization (block wise) - process diagram 9

10 The parameters for the widely configurable minimization algorithms within the Marvin randomization system are configured using the Composer. For every patient entering the study and fulfilling all necessary criteria Marvin calculates the random group assignment as displayed in the diagram below: Logistics Management of Inventory and Shipments The Marvin Randomization System also includes a materials accountability module with (investigational) medical product stock management inventory and logistics. Shipments of materials from a central stock to different sites is managed via a web-based workflow including optional package verification numbers. Shipments can be generated automatically or manually. Then Marvin assigns investigational products to patients according to their (blinded) therapy group. 10

11 5. Coder - Integrated Coding Architecture XClinical s coding system (Coder) is a web-based tool to classify health-related data such as adverse events and medications. It includes coding algorithms based on standard dictionaries MedDRA to auto-encode and manually code verbatim terms and to generate predefined and custom reports. The Coder provides an architecture for seamless integration with EDC systems (Marvin, XClinical s EDC system) via web services (SOAP, XML), eliminating the export/import efforts for data managers. The Coder s workflow enables sponsor approval processes as well as the transfer of coding related queries to the EDC system. Key features are: Powerful search engine on all dictionary levels (LLT/PT, HLT, HLGT, SOC) Automatic and manual coding including sponsor-specific thesaurus (synonym lists) Seamless web-based integration with EDC systems Automation of export/import procedures Automated transfer of coding related queries to EDC system Stand-alone web application - can be used independently of any EDC system Online participation of sponsor staff for approval of difficult cases and validation Pre-defined and customizable online reports of the study coding status XML import and export Full audit trail documentation Web-based, multi-sponsor, multi-database Works on mainstream internet browsers Management of dictionary version upgrades 11

12 6. Marvin for paper: Double Data Entry (DDE) Despite the fact that the majority of clinical data capture is performed electronically there is still a need for paper based data capture under specific circumstances. Typical examples are hybrid studies where the tight integration between EDC and DDE offers notable advantages. Marvin includes DDE capabilities, including free text entries, comments, review process, query and memo workflow, etc. Key features are: Blind DDE: two different users enter data from paper in electronic form independent of one another; neither can see what the other has entered or if there are any discrepancies Dedicated review process: a third person starts a verification process in which the system identifies the differences between both versions and presents them to the user to be resolved Each item allows predefined formats, free text and investigator comments Automated selection of matching forms, batch verification Attachable memos for internal notes and workflow support Automated and manual query workflow including printing Full DDE audit trail Hybrid use of EDC and DDE is possible even for a single patient (e.g. when a site switches from DDE to EDC). 12

13 7. CTMS Clinical Trial Management System The XClinical CTMS is a special type of module including a set of customizable administrative forms, workflows and reports that are completed and processed in the same way CRF forms are completed and processed within the Marvin EDC system. Therefore, the same mechanisms of data review, reporting and communication can be used as in Marvin. For example, a manager can review the completeness and correctness of administrative data entered by monitors using reports as well as automated and manual queries (sent to the monitors instead of to investigators). Data can be automatically extracted from different EDC systems into the XClinical CTMS via the web service interface (SOAP protocol) or via data import procedures avoiding double entry of administrative information. Monitoring reports can be automatically generated (also after data have been reviewed, approved and signed by a manager). The XClinical CTMS is not an out-of-the-box application but needs to be customized according to individual requirements. Therefore, it may be considered as a customized solution. This mechanism is very much oriented towards the future because CTMS forms/pages/reports may be changed at any time in the future without losing data just like an ecrf can be changed via a protocol amendment. Key features are: User administration Site administration General study information and planning Study team management Site initiation Site contract management and financial information Site logistics (e.g. shipping of materials and documents) Management of approval by ethics committees (institutional review boards) Management of approval by regulatory authorities Management of approval by radiation safety authorities Subject insurance management Monitoring visits Audits and quality management visits Site closure 13

14 Professional Services We also offer fast, flexible and focused services. These range from full service to do-it-yourself. Select the services you require and thus create the ideal mix of professional study setup, consulting and training services to meet your specific needs. Our Professional Services team can be responsible for all or just a subset of the points listed below, as required. For those points that you take care of yourself, we will of course continue to provide help and support. Creation of the ecrfs Configuration of Edit Checks / Queries Creation of user roles and access rights Creation of online reports and data export jobs Configuration of specific modules such as Randomization, Drug Accountability and Logistics, Metadata and Libraries Configuration of a separate database with patient identifying information Configuration of laboratory data import The individual XClinical team members will be assigned to the awarded project based on availability at the time of the study start. Everyone in our Professional Services team is experienced with both Marvin and clinical trials. Because we are solely a software vendor, XClinical does not support typical CRO services such as monitoring, data management, biostatistics, protocol writing, etc. Training Services We offer a variety of trainings for the various modules. For Marvin, we provide train-the-trainer sessions so that customers (or designated trainer) can train the site personal. Our software products are user-friendly and easy to use, such that our training units can be kept short (hours or days depending on the topic). For example, within just 3 days data managers can learn how to set up their own study ecrfs and edit checks with the help of our Composer. For investigators, study nurses and monitors we provide training according to the train-the-trainer model. For each Marvin project a separate internet address is available with a copy of the database for training purposes. 14

15 Overview of XClinical Training Modules XClinical Training Concept Marvin for Study Manager and Monitors for Data Manager Set-Up of ecrf with Composer Amendments Roles & Permissions The Basics Specials Data Import Double Data Entry Reporting Basics Advanced Randomization Handling Laboratory Data Tabulation Coding MAP20DM WebPRO Risk-Based Monitoring Webservices Noteflags & Elementflags Customized Trainings: Update Workshop Data Export 15

16 Fact Sheets