CELLULAR THERAPY SOLUTION. Streamline Your Program s Data Management from Start to Finish with Title21 Cellular Therapy Solution

Transcription

1 CELLULAR THERAPY SOLUTION Streamline Your Program s Data Management from Start to Finish with Title21 Cellular Therapy Solution

2 CELLULAR THERAPY SOLUTION PLATFORM Achieve paperless operations with one easy-to-use platform for end-to-end data management Title21 Cellular Therapy Solution is an integrated platform delivering fully-electronic workflows and comprehensive data management to enhance compliance and quality, deliver efficiencies and improve patient safety. The platform streamlines and automates processes throughout clinical, manufacturing and post-infusion follow-up. Clinical System Integration P-10 Collections Management P-3 ISBT 128 Labeling P-6 Quality Management P-11 Laboratory Processing P-4 Data Analytics End-to-End Data Management Workflow Management P-2 Batch Record & Patient Chart Review P-8 Supplies Management P-5 CIBMTR Integration P-8 Product Inventory Management P-7 Traceability 1

3 WORKFLOW AUTOMATION REALIZE EFFICIENT OPERATIONS WITH AUTOMATED, RULES-BASED WORKFLOWS ELECTRONIC FORMS AND WORKFLOWS GUIDE DATA COLLECTION, REVIEW AND APPROVAL THROUGHOUT OPERATIONS WHILE DOCUMENTING TRACEABILITY AND ENSURING CRITICAL DATA IS COLLECTED. EASY-TO-USE Personalized Dashboards Intuitive User Interface Smart Data Fields Auto-calculations Field-Level Validation Populated Data Fields Configurable Control Points INTEGRATED The platform s native integration and modular architecture enables you to deploy solutions in a phased approach according to your priorities, ultimately delivering startto-finish data management within a single database. FLEXIBLE Start with Best-in-Class form templates and workflows and modify to meet specific requirements. This enables agility to dynamic operations including changing protocols, standards of care, and evolving regulatory requirements. 2

4 COLLECTIONS DATA MANAGEMENT TRACK AND DOCUMENT COLLECTIONS DATA WHILE STORING ALL DONOR, RECIPIENT AND PRODUCT DATA IN ONE SYSTEM Manage autologous and allogeneic collections including support for NMDP collections Facilitate donor eligibility determination Document and store donor consent and donor health history information Manage physician orders with specified target collection data specifications Link Donor MRN to Patient MRN Store testing data such as HLA typing and infectious disease marker testing Directly assign LN2 tank placement and track collected product within the natively integrated inventory management system COLLECTIONS Collections Workflows Donor Apheresis Marrow Cord NMDP Send-in NMDP Collections/Send-out 3

5 PROCESSING Product Classes HPC, Apheresis HPC, Marrow HPC, Cord Blood MNC Apheresis T-Cells, Apheresis PROCESSING DATA MANAGEMENT STREAMLINE THE DATA MANAGEMENT OF YOUR LAB S SPECIFIC PROCESSING WORKFLOWS WITH FLEXIBILITY TO ADAPT TO CHANGING PROTOCOLS AND REQUIREMENTS Increase manufacturing throughput and gain processing bandwidth with electronic workflows Assign standard protocols with the ability to add additional protocols Share common and pertinent data across forms, including collection data, recipient data and processing data Aliquot products with automatic calculations based on volume, number of aliquots, and CD34 selection Document bedside thaw or lab thaw/wash data Process infusion orders capturing all critical data Facilitate the disposition of products including lab release, send-out and transfers AUTO/ALLO PROCESSING WORKFLOWS o Unmanipulated o Volume/RBC/Plasma Reduction o Division/Pooling o Cryopreservation o CD34 Selection o Infusion o Double-Cord Haplo o DLI o Cord Blood Processing/Banking SAMPLING WORKFLOWS o Cellular Immunology o Hematology o IDM o Gram o Micro o Serology o Molecular o CFU Plate/Count o ARC/FTA 4

6 SUPPLIES DATA MANAGEMENT SUPPLIES & EQUIPMENT ENSURE THE TRACEABILITY OF CONSUMED SUPPLIES THROUGHOUT THE MANUFACTURING PROCESS Quickly access documentation of all products in contact with supplies in the event of a manufacturer recall Manage the inventory of supplies with automated alerts, re-order tasks and warnings of approaching expirations Document and track supply qualification, acceptance and validation Track supplies by lot number, expiration dates, receipt date, open-on date and other parameters Efficiently record the consumption of supplies via supply selection, barcode scan of individual supply or barcode scanning of grouped supply kits EQUIPMENT DATA MANAGEMENT MINIMIZE THE COMPLIANCE AND SAFETY RISKS OF OUT-OF-SPECIFICATION AND OUT-OF- CALIBRATION EQUIPMENT Schedule and record equipment maintenance and calibration activities Store compliance documentation such as user manuals, repair information, SOPs and validation documentation on electronic equipment profiles Capture variable parametric calibration data with out-of-specification and out-of-range alerts to prevent human error or identify compliance issues Prevent the use of equipment throughout the manufacturing process that is not up-to-date on compliance activities Achieve traceability to equipment and instruments used throughout the manufacturing workflow 5

7 ISBT 128 LABELING A Complete Selection of ISBT 128 Compliant Label Templates Full Distribution Label Full Collection Label Partial Label (2X4) Partial Label (4x2) Cryopreservation Label Product Code Label Custom Label Format ISBT 128 LABEL PRINTING & BARCODE SCANNING SAVE TIME AND INCREASE PATIENT SAFETY WITH INTEGRATED AND COMPLIANT ISBT 128 LABEL PRINTING Print ISBT 128 compliant labels directly from the Title21 interface throughout the collections and manufacturing workflow Scan ISBT 128 label barcodes to auto-populate data into electronic forms within the system Generate DINs or populate existing DINs via barcode scan Simplify staying up-to-date with ICCBBA technical updates Save time with automatically filtering product codes as you move throughout the processing workflow Certified Digi-Trax partner 6

8 PRODUCT INVENTORY PRODUCT INVENTORY DATA MANAGEMENT COMPREHENSIVE INVENTORY TRACKING AND CONTROL TO INCREASE VISIBILITY OF INVENTORIED PRODUCT AND ENSURE COMPLIANT PRODUCT STORAGE Facilitate product placement through visible electronic views of your storage configuration and automatic identification of next available location Reserve inventory locations for a specific patient or product to enable consecutive and logical storage placement Mirror your freezer and storage configuration in the flexible interface (e.g. shelves, racks, boxes, tanks) Verify actual inventory with e-signature approvals Identify the location and status of inventoried products through easy-to-use search and query tools Run real-time reports on inventory levels Document the chain of custody across multiple and varied inventory locations including vapor shippers, on-site storage, and off-site storage inventory management system Access on Windows-based tablets 7

9 BATCH RECORD MANUFACTURING BATCH RECORD & PATIENT CHART REVIEW BRING TOGETHER ALL THE DATA NEEDED FOR A COMPLETE LABORATORY BATCH RECORD, FACILITATING EFFICIENT APPROVAL OR REJECTION OF PRODUCT RELEASE FOR INFUSION OR TRANSPLANT VIA COMPLIANT E-SIGNATURE Lock the laboratory processing record upon medical director e-signature Any documentation gaps, errors, flags or patient safety concerns are alerted to the user throughout the process to ensure a thorough and efficient batch record review and sign-off Automate the Assembly of Critical Data Identification of critical supplies, reagents & equipment Processing data Testing results Identification of lab personnel Quality data 8

10 CIBMTR & CLINICAL DATA MANAGEMENT STREAMLINE THE DATA MANAGEMENT AND MANDATORY REPORTING OF YOUR INTEGRATED CIBMTR DATA Complete CIBMTR form submissions for all AGNIS-supported forms in a single click via the Title21 interface Reduce double-data entry by populating data collected upstream from your EHR and laboratory processing forms Perform data analysis using KPI charts, query tools and comprehensive reporting of realtime and historical clinical data Manage the due dates, notifications and documentation of forms due and postinfusion follow-ups Download legacy data for outcomes analysis and reporting Track, trend and query on key metrics that measure without staff spending valuable time manually compiling data and tracking down paper UTILIZE PREDEFINED REPORTS OR GENERATE ADDITIONAL REPORTS TO REPORT ON ANY DATA CAPTURED WITHIN THE SYSTEM Primary Disease RFI Clinical Statistics RFI Survival by Disease Kaplan-Meier Variance Correlation Product Release Information Certificate of Analysis Available Inventory Adverse Reactions Processing Data Summary Infusion Data Summary Cell Dose Viability Engraftment 9

11 INTEROPERABILITY INTEGRATION AND INTEROPERABILITY INTEGRATION TO EXTERNAL INFORMATION SYSTEMS MINIMIZES DOUBLE-DATA ENTRY, REDUCES TRANSCRIPTION ERRORS AND LESSENS THE BURDEN OF MANUALLY INPUTTING DATA FROM ONE SYSTEM TO ANOTHER, SAVING STAFF TIME, REDUCING RISK AND INCREASING PATIENT SAFETY CLINICAL DATA SYSTEM INTEGRATION Integrate Title21 Cellular Therapy Solution with clinical data systems to push and pull data through encrypted and secure channels Pull in patient data from clinical systems including EPIC, Cerner, McKesson, Allscripts, and MEDITECH LABORATORY INSTRUMENTS Interface with laboratory instruments, enabling the secure transfer and auto-population of instrument data into applicable forms within the system Transfer Protocols LLP, HTTP/HTTPS, FTP/FTPS/ SFTP, Web Services (SOAP, RESTful), Database, File system, TCP/IP Data Formats HL7 v2, HL7 v3, FHIR, CDA, CCD, X12, NCPDP, DICOM, EDI, XML, JSON, Delimited text 10

12 QUALITY MANAGEMENT & INSPECTION PREPAREDNESS INTEGRATED QUALITY DATA MANAGEMENT AUDIT & INSPECTION READINESS COMPREHENSIVE QUALITY MANAGEMENT SOLUTIONS NATIVELY INTEGRATED AND STORED IN THE SAME DATABASE AS THE TITLE21 CELLULAR THERAPY SOLUTION SUPPORTS COMPLIANCE AND ADHERENCE TO THE SPECIFIC REGULATORY AND ACCREDITATION STANDARDS OF CELL THERAPY ENVIRONMENTS Document Control with Read-and-Sign Training and Periodic Review Planned/Un-planned Deviations Error & Nonconformance Management Corrective Actions and Preventive Actions Change Control Complaint Handling Training & Competency Management Audit Management Regulations and Standards Maintenance Accurate documentation, complete traceability, and prompts to stay up-todate on compliance activities support your program s inspection readiness. 21 CFR Part 11 Compliance Electronic Signatures Full Roles-Based Security Model and Audit Log Complete validation package suitable for inspection by regulatory and accreditation agencies Learn More about Title21 Cellular Therapy Solution Request a Demo Talk to a Product Specialist Title21 Request More Product Information 11

13 Title21 Health Solutions 7031 Koll Center Parkway, Suite 110 Pleasanton, CA Title Title21 Software, Inc. All Rights Reserved Digi-Trax Corporation 2016 Epic Systems Corporation 2016 CERNER CORPORATION 2016 McKesson Corporation 2016 Medical Information Technology, Inc ICCBBA 2016 Allscripts Healthcare Solutions, Inc AGNIS 2016 National Marrow Donor Program CIBMTR is a copyright of The Medical College of Wisconsin, Inc. and the National Marrow Donor Program. Windows is a copyright of Microsoft. All Rights Reserved.