Understanding When to Employ IVR and IWR independently or in Combination
|
|
- Leo Stafford
- 8 years ago
- Views:
Transcription
1 Understanding When to Employ IVR and IWR independently or in Combination Scott C. Wong Sr. Systems Analyst, IVRS Central Management Global Investigational Materials Supply Chain Celgene Agenda What are interactive voice response (IVR) and interactive web response (IWR) systems? Overview of general ITS functionality Benefits of using an IWR ITS System Development Developing ITS Standards ITS Case Study Predictive Supply Reporting Capabilities 1
2 Interactive Voice/Web Response Systems Touch tone telephone or web based technology Caller responds to pre-recordedrecorded prompts (data input) via the phone (IVR) and receives voice response instructions User responds to Pre programmed questions and web text via a secured web page (IWR) and receives on-screen instructions 24/7 Direct interaction with global shared database via the keypad on your telephone or your keyboard E.g. Online banking and Phone reservations for movies/trains/etc Notifications / alerts regarding patient status or activities are generated as a function of activities performed within the system ITS Functionality 2
3 ITS Functionality Subject Enrollment Manage complex randomization schemes Clinical Drug Supply Management Sending Study Medication only when its needed to conserve overall study supplies Manage and Simplify Trial Logistics Site Management Site Statistics and Recruitment Subject Medication Assignment from a single/pooled medication pack list Emergency Subject Unblinding (IVR only?) Electronic Patient Reported Outcomes (epro) Real Time Confirmations and Web Based Reporting IVR vs. IWR Country Participation Data shows fewer errors are made from a data entry perspective using IWR Visual vs. Auditory IWR is better for non site user types where large amounts of data need to be entered Most North American and European sites have used IWR and request IWR In all cases IVR should be used with IWR as an add on. IVR can still be the quickest and most convenient method of input for sites Using both IVR and IWR are generally more expensive then a single platform BOTH MUST BE TESTED 3
4 Cost Benefits IVR vs. IWR can be protocol driven Amount of Data Collected Complexity of Medication Management Number of Stratification and Eligibility questions Study Duration Number of Subjects and Countries ITS Budget Owners Clinical Budget Owners are less influenced by Medication Overage and more concerned with Patient Recruitment Benefits of Using an IWR 4
5 Benefits of using IWR Site Personnel Users Single point of access to event functionality, web reporting and clinical drug accountability via a secure web page Stratification and eligibility questions are provided visually reducing errors in randomization Site and Pharmacy Personnel can review multiple orders in transit Register multiple shipments as having arrived in one transaction Pick and choose ranges of kits that are damaged or missing in shipments rather than selecting kits one by one Request additional copies of event notifications Update Site Contact Details Access Kit Assignment Summary Reports Benefits of using IWR Sponsor Users Online Interactive Site Management Activate/Deactivate Study Sites Online Trigger initial shipments Open/Close enrollment and monitor recruitment Review and Update Supply Strategies for Individual Sites Forecast Supply chain via dashboard reporting Events requiring large amounts of Data Input are simplified Events requiring large amounts of Data Input are simplified using a visual interface Depot to Depot Transfers by quantity or sequence range Manage Expiry and Relabeling activity Access Real Time Subject and Inventory Data 5
6 ITS System Development I want to use an IVR/IWR. An IVRS of moderate complexity requires a week build time It can be done in shorter timeframes: Reusable code libraries Client Specific Standards Reduced IVR systems Simplified Randomization Basic Medication Management 6
7 ITS Build Lifecycle ITS Specification Development: (3 to 4 weeks) Sponsor + Vendor ITS programming (4-6 weeks) Development of user documentation Development of Test Plans and UAT strategy User Acceptance Testing (UAT) : 2-3 days Sponsor testing of the system compared to the specification UAT Participation Global Study Manager, Clinical Research Scientists, Clinical Supplies, IVRS Subject Matter Experts Go Live: (0-3 days) Loading of Live Medication and Randomization listings Ancillary Translations ITS Standards 7
8 Developing Standards for IVR/IWR systems to reduce timelines Core Specification Template Defines Standard Call types required for all studies Screening, Screen Failure, Discontinuation, etc. Defines Standard Terminology Center vs. Site Subject vs. Patient Defines Numbering Format Center Number Subject ID Number Standard Package of Alerts, Notifications and Web Reports List of System Users, Roles and Responsibilities Medication Management trends Approval Procedure for live Data ITS Call Types Locked Down Data Points collected in each transaction Gender, initials, informed consent date, etc. Benefits of a Standard ITS Reduces the learning curve for first time study team users Eliminates system discrepancies across similar studies Less painful specification development procedure Shorter system development time More efficient User Acceptance Testing Familiar Systems are provided to Site Personnel 8
9 ITS Case Studies ITS Case Study 1 Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to compare the efficacy and safety of Treatment Arm A in Subjects with Myelofibrosis Study Details 2 Treatment Arms (Active and Placebo) 100 subjects 7 day Screening Period 28 day cycles Dose Escalations and Reductions 2 stratification factors (gender and age) 8 ambient and inexpensive kit types (4 doses of Active and 4 doses of Placebo) 9
10 ITS Requirements Should we use IVR or IVR and IWR? When should we send our initial shipment of medication? Do we send all medication at once? What type of Medication Management should we use? Trigger/Resupply? Resupply all or only triggered kit types? Prediction? If we use prediction, what type of Predictive Medication Supply Strategy can we use to ensure medication is readily available at site? Break Out Session 10
11 Prediction Works with a fixed visit schedule Not always suggested to be used in titration studies with numerous dose levels (max 8-10), and frequently expected Unscheduled visits IVRS identifies 2 ranges Check Range how far should the system look ahead to identify a need? Restock Range how much further should the system look ahead and restock for when it identifies patients within the check range? Determining the Need using only Prediction Check Range : 7 Days Restock Range : 2 cycles, or 56 days Patient A TG A Patient B TG B Patient C TG C Using the above example of check range of 7 days and restock range of 56 days, what treatment Groups will be Predicted? 11
12 Prediction: Determining the Need Treatment Group A and C fell within the Check Range, therefore the IVRS looked forward 2 more cycles and calculates the need Assure visit within the check range is included within your calculation Trigger and Resupply with Prediction (AKA Prediction and Buffer) Same thing as Prediction however when need is calculated a buffer stock is taken into account Emergency Resupplies Many titrations Possibility for many unscheduled visits Competitive Recruitment Shipment size is determined on 3 factors: Site inventory that is on site or already in transit If sufficient inventory is available for predicted visits in the check range If sufficient inventory is available for predicted visits in the restock range 12
13 Prediction with titration Depends on study titration rules Using titration doses 10mg, 8mg, 6mg as an example, 3 options: Stepwise up and down titration permitted Predict the current, dose above and dose below No Up titration Predict current dose and one dose below At 8mg predict 8mg and 6mg Only 1 down titration Depending on starting dose Predict current dose and one dose below ITS Case Study 2 Phase 2, Multicenter, Randomized, Open-Label to determine the efficacy of Treatment Arm A versus Investigator s Choice Medication Study Details: 2 Treatment Arms (Treatment A vs. Investigator s Choice Arm) Minimum 21 day screening Period 3 stratification factors (gender, time since diagnosis, Presence of the following poor prognostic factors ) 11 kit types (6 inexpensive kit types of Treatment Arm A of various doses and 5 Different and VERY EXPENSIVE kit types for Investigator s t Choice Arm that t are easily damaged. d 1 of the Investigator s Choice Medication is cold chain) Investigator Choice Arm is dosed by Body Surface Area Treatment arm A can be both Dose Escalated/Reduced Only Treatment Arm A is required for Site initiation Visit 13
14 Investigator Choice Arm Assignment Subject Body Surface Area Kit type 1 Kit type 2 Kit type 3 Kit type 4 Kit type 5 Kit type ITS Requirements Should we use IVR or IVR and IWR? When should we send our initial shipment of medication? Do we send all medication at once? Should we combine different drug types in one shipment? How can we maximize the use of our IVR/IWR to control resupply shipments of Investigator Choice Drug? Should we use Trigger/Resupply? Resupply all or only triggered pack types? Should we use Prediction? 14
15 ITS Reporting Web Reports for Clinical Supplies Patient Enrollment Patient totals Unblinded Inventory Inventory totals by lot and pack type at depot and site Kit Assignment Summary Shows what has been ordered and sent to site by kit ID and shows current kit status Unblinded Shipment Summary Date raised, dispatched, arrived, cancelled, tracking, packs in order Data Extract 15
16 Alerts Expiration Medication is X days from the expiration date DNS, DNC, DND Low depot inventory Set at a threshold so there is time to react Recruitment Milestones Partial and Failed Order Alerts Sent to a predefined and adjustable distribution list Thank you! Questions? 16
How to Utilize an IVRS for Efficient Management of Clinical Supplies
How to Utilize an IVRS for Efficient Management of Clinical Supplies Scott C. Wong IVRS Senior Systems Analyst Investigational Material Supply Chain Celgene Corporation Objective Provide a basic understanding
More informationUsing IVRS in Clinical Trial Management
Using IVRS in Clinical Trial Management Bill Byrom Interactive voice response systems can work for project managers as an inventory management tool, a real-time project information tool, and a subject
More informationEquipping your Forecasting Toolkit to Account for Ongoing Changes
Equipping your Forecasting Toolkit to Account for Ongoing Changes Presented by: Roger Parlett Supply Chain Manager January 23, 2014 Overview Forecast Set-up Objectives of Creating a Forecast Identify Critical
More informationBest Practice Approaches to Improving Clinical Supply Chain Management. Matthew Do Client Development Lead Almac Pharmaceutical Services
Best Practice Approaches to Improving Clinical Supply Chain Management Matthew Do Client Development Lead Almac Pharmaceutical Services A variety of challenges complicate trial supply management Multiple
More informationReflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
More informationIntroduction. VP, Sales in a Global Courier Company
ARTICLE AUGUST 2014 Abstract: Impact analysis of Just in Time packaging and labeling on clinical supply chain Clinical supply chain is in intense pressure for better management due to factors like globalization
More informationAGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE
WHITE PAPER AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE Randomization is fundamental to clinical trials it enables treatment group balance, eliminates
More informationIXRS Interactive Voice and Web Response System. MTN Annual Meeting ASPIRE Trial
IXRS Interactive Voice and Web Response System MTN Annual Meeting ASPIRE Trial Presenter: Tracie DiPasquale Materials Planning and Supply Chain Lead MTN Regional Meeting: 3-October-2012 Overview Introduction
More informationMinimize overspend by gaining visibility of total demand
Minimize overspend by gaining visibility of total demand Patti Seymour 9th Annual Clinical Trials Supplies and Packaging October 10-12, 2011 BioProcess Technology Consultants www.bptc.com Supply and Demand
More informationOptimizing the Clinical Trial Supply Chain
white paper Optimizing the Clinical Trial Supply Chain Ensuring the right items arrive in the right place, in the right quantity, at the right time and within budget. Testing out new medicines around the
More informationInteractive Response Technologies
Interactive Response Technologies Increasing accuracy and efficiency in clinical trials To increase the accuracy and efficiency of conducting your global clinical trials, ICON s Interactive Response Technologies
More informationDeveloping a Strategy to Optimize Clinical Trial Supplies
Developing a Strategy to Optimize Clinical Trial Supplies Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners.
More informationORACLE HEALTH SCIENCES INTERACTIVE RESPONSE TECHNOLOGY (IRT)
ORACLE HEALTH SCIENCES INTERACTIVE RESPONSE TECHNOLOGY (IRT) KEY BENEFITS FOR CLINICAL OPERATIONS Increase efficiency and safety in clinical supply chains with sophisticated algorithms and an easyto-use
More informationAdoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
More informationPractical Applications for Clinical Demand and Operations Planning
Practical Applications for Clinical Demand and Operations Planning Randy Schwemmin Genentech Clinical Demand and Supply Planning Biotech Supply Chain Academy 8 November 2011 Agenda Vision for Clinical
More informationRIVRS User Manual. Template: WCT-TMP-RS-072-01. Effective: 20-Apr-2016 Version: 1.0 Page 1 of 18
RIVRS User Manual Version: 1.0 Page 1 of 18 Table of Contents General Information: 3 Accessing the IxRS 4 IVRS - Call the telephone number for your country 4 IWRS - Go to https://www.wwctrials.net/bmsiwrs
More informationSection 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership
Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership PROJECT MANAGEMENT - SCOPE DEFINITION AND MANAGEMENT Understands the
More informationCTMS Protocol Planning, Setup, and Maintenance
CTMS Protocol Planning, Setup, and Maintenance Updated: 09-Jul-2014 Updated: 09-Jul-2014 Page 2 of 22 Table of Contents Protocol Planning and Setup... 6 Protocol Set-Up Process... 6 Protocol Setup Requirements
More informationCLINICAL DEVELOPMENT OPTIMIZATION
PAREXEL CLINICAL RESEARCH SERVICES CLINICAL DEVELOPMENT OPTIMIZATION Enhancing the clinical development process to achieve optimal results ADVANCED TECHNOLOGY COMBINED WITH INTELLIGENT THINKING CAN HELP
More informationInForm On Demand Single Trial Services Description
InForm On Demand Single Trial Services Description Version 7.0 Effective Date: 0 25-Sep-2014 This is the Services Description for Oracle InForm On Demand Single Trial ( Schedule ) to Your Study Order for
More informationPHASE IIB III. inventivhealthclinical.com
PHASE IIB III inventivhealthclinical.com 1 Table of Contents OVERVIEW 02 DATA DRIVEN, COST EFFECTIVE SOLUTIONS Feasibility Studies 03 Investigator Recruitment and Site Management 03 Patient Enrollment
More informationREDUCING THE RISKS INHERENT IN EMERGENCY MEDICAL CONTACT AND UNBLINDING
white paper REDUCING THE RISKS INHERENT IN EMERGENCY MEDICAL CONTACT AND UNBLINDING All sides agree that patient safety is paramount in the conduct of clinical trials. While focused on patient safety,
More informationLorna Briddick Managing Partner Brizzey LLC. 10/30/2014 October 30, 2014 1
Global Clinical Supplies & The Road Less Traveled: Navigating the bumps, pot holes and detours that come with the development and delivery of Investigational Products Lorna Briddick Managing Partner Brizzey
More informationStreamlining clinical trial supply management
Life Sciences Clinical Trial Supply Management Streamlining clinical trial supply management Driving faster, more effective clinical trials In this white paper A critical step of the development chain:
More informationPROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain
P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract
More informationTEMPLATE DATA MANAGEMENT PLAN
TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager
More informationGuidance on the content of a pharmacy manual to support clinical trial protocols
Guidance on the content of a pharmacy manual to support clinical trial protocols This guidance has been produced to help investigators with the content of pharmacy manuals for clinical trials. We gratefully
More informationLogistics. Drug Pooling in the Clinical Trial Supply Chain
Drug Pooling in the Clinical Trial Supply Chain Abstract Global clinical trials require efficient and robust supply chain which can bring more transparency and can introduce risk mitigation strategies.
More informationA PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT
Accelovance 2275 Research Boulevard, Suite 700 Rockville, MD 20850, United States Phone: +1.240.238.4900 Fax: +1.240.238.4901 Internet: www.accelovance.com email: gsmith@accelovance.com Contact Person:
More informationVersion history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy
Trial name: HOVON xxx yyy Sponsor: HOVON Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy QRMP authors
More informationBalancing Risk and Costs to Optimize the Clinical Supply Chain A Step Beyond Simulation
J Pharm Innov (2009) 4:96106 DOI 10.1007/s12247-009-9063-5 CASE REPORT Balancing Risk and Costs to Optimize the Clinical Supply Chain A Step Beyond Simulation Chedia Abdelkafi & Benoît H. L. Beck & Benoit
More informationBeyond the White Box: Why Patient Friendly IP Packaging Matters
Beyond the White Box: Why Patient Friendly IP Packaging Matters KRISTEN DEVITO Global Director, CSS Business Solutions Catalent Pharma Solutions Presented to 17 March 2015 Introduction The increasing complexity
More informationClinical Trial Management Software
Clinical Trial Management Software For single-site and multi-site organizations, Maptrial is a cloud-hosted clinical trial management system (CTMS) designed to track the operational data of clinical trials
More informationDrug Pooling in Clinical Trial Supply Chain
Drug Pooling in Clinical Trial Supply Chain Drug pooling in clinical trial is a process where common IMPs or Non-IMPs are pooled together for similar protocols running at each site followed by pooled distribution
More informationInvestigational Drugs: Investigational Drugs and Biologics
: I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place
More informationMonte Carlo Simulations for Patient Recruitment: A Better Way to Forecast Enrollment
Monte Carlo Simulations for Patient Recruitment: A Better Way to Forecast Enrollment Introduction The clinical phases of drug development represent the eagerly awaited period where, after several years
More informationClinical Supply Chain: Audio Transcript Slide 1: Welcome to the Clinical Supply Chain Course. The upcoming lessons will help you become familiar with
Clinical Supply Chain: Audio Transcript Slide 1: Welcome to the Clinical Supply Chain Course. The upcoming lessons will help you become familiar with the dynamics involved in the pharmaceutical Clinical
More informationThe Whole Product An Integrated Approach to Evaluating & Selecting a Clinical Trial Management System
The Whole Product An Integrated Approach to Evaluating & Selecting a Clinical Trial Management System Summary For institutions, deriving real value from investments in a clinical trial management system
More informationQuality Monitoring Checklist
Quality Monitoring Checklist Instructions: For each task below, the Quality Monitor indicates in the appropriate column if the Monitor accomplished the task by using the following codes Yes No N/A = Monitor
More informationIMP management at site. Dmitry Semenyuta
IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records
More informationSimulation-based Optimization Approach to Clinical Trial Supply Chain Management
20 th European Symposium on Computer Aided Process Engineering ESCAPE20 S. Pierucci and G. Buzzi Ferraris (Editors) 2010 Elsevier B.V. All rights reserved. Simulation-based Optimization Approach to Clinical
More informationSupply Chain Management Use Case Model
Supply Chain Management Use Case Model Date: 2002/11/10 This version: http://www.ws-i.org/sampleapplications/supplychainmanagement/2002-11/scmusecases-0.18- WGD.htm Latest version: http://www.ws-i.org/sampleapplications/supplychainmanagement/2002-11/scmusecases-0.18-
More informationBest Practices for Inventory Control Using Dynamics GP
Best Practices for Inventory Control Using Dynamics GP Inventory Humor Agenda Sales Inventory Valuation Methods Reason Code Troubleshooting Cost Issues Taking Physical Inventory Counts Landed Cost Review
More informationBiorepository and Biobanking
Biorepository and Biobanking LabWare s solution for biorepositories and biobanks combines powerful specimen tracking and logistics capabilities with specimen processing and workflow management features.
More informationClinical Data Management Overview
The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related
More informationHow to Set Up and Use PeopleSoft Procurement and Supplier Contracts
How to Set Up and Use PeopleSoft Procurement and Supplier Contracts Keith Olander Director Product Management SCM PeopleSoft Copyright 2014 Oracle and/or its affiliates. All rights reserved. Oracle Confidential
More information5.1 4.1 4.2 4.3 PROCESS GROUP: PLANNING PROCESS GROUP: INITIATION. Oracle Projects. PMBOK Oracle Mapping. Scope Planning. Develop Project Charter
Develop Project Charter Develop Preliminary Project Scope Statement Develop Project Management Plan Scope Planning PROCESS GROUP: INITIATION 4.1 The project charter serves as the input document for the
More informationSAS and Clinical IVRS: Beyond Schedule Creation Gayle Flynn, Cenduit, Durham, NC
Paper SD-001 SAS and Clinical IVRS: Beyond Schedule Creation Gayle Flynn, Cenduit, Durham, NC ABSTRACT SAS is the preferred method for generating randomization and kit schedules used in clinical trials.
More informationmsd medical stores department Operations and Sales Planning (O&SP) Process Document
msd medical stores department Operations and Sales Planning (O&SP) Process Document August 31, 2011 Table of Contents 1. Background... 3 1.1. Objectives... 3 1.2. Guiding Principles... 3 1.3. Leading Practice...
More informationRisk based monitoring using integrated clinical development platform
Risk based monitoring using integrated clinical development platform Authors Sita Rama Swamy Peddiboyina Dr. Shailesh Vijay Joshi 1 Abstract Post FDA s final guidance on Risk Based Monitoring, Industry
More informationEMR Technology Checklist
Patient Accessibility/Scheduling/Account Maintenance: Able to interact with schedule through an online portal pre register VIP status to move patient to the front of the line Access and pre registration
More informationGuideline for Developing Randomization Procedures RPG-03
The Clinical Research Center Research Practice Manual Guideline for Developing Randomization Procedures RPG-03 Purpose Guideline The purpose of this Guideline is to outline the Clinical Research Center
More informationBika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management
Bika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
More informationHuawei Managed Services Unified Platform (MS UP) v1.0
Huawei Managed Services Unified Platform (MS UP) v1.0 Representation of Solution Functionality/Capability Utilizing etom, ITIL and TL 9000, Huawei Managed Services has integrated these three global standards
More informationWhite Paper January 2009. Top Ten Reports in Clinical Performance Management
White Paper January 2009 Top Ten Reports in Clinical Performance Management 2 Contents 3 The solution Clinical Performance Management Clinical Trail Resource Planning Reports Report #1 Clinical Trial Project
More informationUniversity of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol
University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of
More informationLogin. 1. Enter your User ID into the User ID text box using the keyboard. 2. Use the Tab or Enter key to move to the PIN text box.
Login 1. Enter your User ID into the User ID text box using the keyboard. 2. Use the Tab or Enter key to move to the PIN text box. 3. Enter your PIN into the PIN text box using the keyboard. 4. Touch the
More informationOngoing inventory management with the Pyxis MedStation
Ongoing inventory management with the Pyxis MedStation system Introduction Stock levels and drug lists are dynamic in the Pyxis MedStation TM system, especially when most medication(s) are distributed
More informationRoadmap for study startup
How-To Guide Roadmap for study startup Deploying Adobe technology to automate clinical study startup procedures Section 1: Introduction and overview 2 1.1 Introduction 2 1.2 Overview of the clinical study
More informationMost recent research on clinical trials
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2012, Vol. 32 No. 4 www.pharmaceuticalengineering.org Copyright ISPE 2012 This article presents the R&D supply chain
More informationPerspectives on Patient Recruitment
Webcast Perspectives on Patient Recruitment Sponsors: Presenters Moderator: Christiane Truelove Editor in Chief, R&D Directions Chris.Truelove@ubm.com Speakers: Dr. Bradley Vince, D.O., President and Medical
More informationRole of the Investigational Drug Services (IDS) in the Management of Investigational Drugs
Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Charlesworth Rae, BS, PharmD, JD Investigational Drug Pharmacist July 2012 1 Outline of Presentation I. Introduction
More informationTRANSFORMING LIFE SCIENCES THROUGH ENTERPRISE ANALYTICS
TRANSFORMING LIFE SCIENCES THROUGH ENTERPRISE HOW SOLUTIONS AND ENTERPRISE ENVIRONMENTS ARE IMPROVING EFFICIENCY AND ENABLING NEW INSIGHTS THROUGHOUT THE LIFE SCIENCES INDUSTRY Matt Gross Director Health
More informationTable of contents. TRAVERSE Business Solutions use 100% Microsoft.NET and SQL Server technology.
Our mission is to help our customers become more successful by delivering products and services that exceed expectations, to focus on excellence, to provide individual consideration, and to create both
More informationASCO. R&D Supply Chain and Clinical Trials Supply Management A Life Sciences Solution. Award for the "Best Business Transformation project 2010
ASCO Award for the "Best Business Transformation project 2010 R&D Supply Chain and Clinical Trials Supply Management A Life Sciences Solution Geert Crauwels Partner Life Sciences Industry Lodestone Amelia
More informationthrough advances in risk-based
Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform
More informationIf several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.
General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary
More informationGOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE
ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's
More informationEMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
More informationwww.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS
Global clinical trial solutions. Real-world results. Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Clinical Trial Management Clinical Data Management www.bioclinica.com
More informationJournal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators
Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Shaikha Al Naimi Doctor of Pharmacy Student College of Pharmacy Qatar University
More informationHow To Model Drug Supply
Drug Supply Modelling Software Vladimir V. Anisimov, Valerii V. Fedorov, Richard M. Heiberger, and Sourish C. Saha Research Statistics Unit, GlaxoSmithKline Department of Statistics, Temple University
More informationTELEPHONE BUTTONS & ICONS TOUCHSCREEN OVERVIEW
This Telephone Guide describes the various features available to you. Telephone Buttons and Icons describe the physical buttons and keys on the phone, the Touchscreen Overview outlines basic functions,
More informationSharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,
More informationAn information platform that delivers clinical studies better, faster, safer and more cost effectively
An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites
More informationFunctional Specifications of the eztrial Clinical Trial Information Management System
TR-IIS-10-004 Functional Specifications of the eztrial Clinical Trial Information Management System Hong-Yi Chen, Chung-Tsuo Lin, Chia-Hui Chang, Yi-Ru Cian, Yi-Fang Lee, and Chun-Nan Hsu June, 15 2010
More informationOrder Management: Overview and Solution Options
Order : Overview and Solution Options Sapient Corporation 2011 1 Order Title of : White Paper Overview Lorem ipsum and Solution dolor sit Options amet Order : Overview and Solution Options Many Multi-channel
More informationHow Is OnabotulinumtoxinA Reimbursed For Chronic Migraine? Impact Of FDA Approval And The New CPT Code
How Is OnabotulinumtoxinA Reimbursed For Chronic Migraine? Impact Of FDA Approval And The New CPT Code Effective January 1, 2013, physicians will be able to report the new CPT code 64615 when performing
More information3.7 Logistics Execution
106 3 SAP EP Operations 3.7 Logistics Execution The Logistics Execution (LE) component controls and organizes both the movement of material within the enterprise (warehouse management) and also transportation
More information1. Overview of Clinical Trials
1. Overview of Clinical Trials 1.1. What are clinical trials? Definition A clinical trial is a planned experiment which involves patients and is designed to elucidate the most appropriate treatment of
More informationWeb appendix: Supplementary material. Appendix 1 (on-line): Medline search strategy
Web appendix: Supplementary material Appendix 1 (on-line): Medline search strategy exp Venous Thrombosis/ Deep vein thrombosis.mp. Pulmonary embolism.mp. or exp Pulmonary Embolism/ recurrent venous thromboembolism.mp.
More informationHitachi ID Password Manager Telephony Integration
Hitachi ID Password Manager Telephony Integration 2015 Hitachi ID Systems, Inc. All rights reserved. Contents 1 Introduction 1 2 Functional integration 2 2.1 Self-service password reset....................................
More informationStudy Designs. Simon Day, PhD Johns Hopkins University
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this
More information101 ways to use SysAid
101 ways to use SysAid Keep IT simple by letting SysAid do what it does best- help you manage your IT. Print out this handy checklist of everything you can do with SysAid, and make sure you are taking
More informationGuideline for Developing Randomization Procedures RPG-03
The Clinical Research Center Research Practice Manual Guideline for Developing Randomization Procedures RPG-03 Purpose Guideline The purpose of this Guideline is to outline the Clinical Research Center
More informationAccess to a unified real-time solution enables your company to make informed decisions and maximize profitability.
FEATURES OVERVIEW The Operational Networked Elements (ONE) platform serves as the base infrastructure and information integration for B2W Estimate and the B2W Operational Suite unifying resources across
More informationWhitePaper. The Business Value of Call Accounting Software How Call Accounting Helps Reduce Telecom Expenses and Improve Productivity
The Business Value of Call Accounting Software How Call Accounting Helps Reduce Telecom Expenses and Improve Productivity WhitePaper We innovate. You benefit. The Business Value of Call Accounting Software
More informationPackManager user guide
Presource Products and Services Presource Products and Services Cost savings Standardization opportunities Inventory management Pricing and predictability PackManager user guide Procedure pack management
More informationEnd to end Clinical Trial Supply Management with SAP
End to end Clinical Trial Supply Management with SAP by Infosys Lodestone CTSM is a leading factor in conducting clinical studies. Table of Contents A Leading Factor in conducting Clinical Studies is the
More informationOVERVIEW OF THE SUPPLY CHAIN ROADMAP
OVERVIEW OF THE SUPPLY CHAIN ROADMAP Windows Client IFS CUSTOMER SUMMIT 2011, CHICAGO DARLA BLOOM SENIOR ADVISOR darla.bloom@ifsworld.com OVERVIEW OF THE SUPPLY CHAIN ROADMAP AGENDA Supply Chain Program
More informationQAD Service and Support Management
QAD Service and Support Management QAD Service and Support Management (SSM) is the core component of QAD s Service and Support suite and is uniquely suited for manufacturers, as it is deeply integrated
More informationMedical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11
Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies
More informationRole of eclinical Systems in FDA Regulated Studies. Jonathan S. Helfgott
Role of eclinical Systems in FDA Regulated Studies Presented by: Jonathan S. Helfgott Operations Research Analyst Office of Scientific Investigations Disclaimer The contents of this presentation are my
More informationGenerating Randomization Schedules Using SAS Programming Chunqin Deng and Julia Graz, PPD, Inc., Research Triangle Park, North Carolina
Paper 267-27 Generating Randomization Schedules Using SAS Programming Chunqin Deng and Julia Graz, PPD, Inc., Research Triangle Park, North Carolina ABSTRACT Randomization as a method of experimental control
More informationWhat Cancer Patients Need To Know
Taking Part in Clinical Trials What Cancer Patients Need To Know NATIONAL INSTITUTES OF HEALTH National Cancer Institute Generous support for this publication was provided by Novartis Oncology. Taking
More informationFREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C
FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor
More informationThe Business Value of Call Accounting
WHITE PAPER The Business Value of Call Accounting How Call Accounting Software Helps Reduce Business Expenses and Improve Productivity Introduction Call accounting software has been available for more
More informationVersion History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author
Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required
More informationHow To Write A Binder Tab
Tool Summary Sheet Tool: Extramural Essential Documents Binder/File Tabs Purpose: To provide an organizational framework and guidance for filing paper versions of essential study documents (or referencing
More information