A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT

Size: px
Start display at page:

Download "A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT"

Transcription

1 Accelovance 2275 Research Boulevard, Suite 700 Rockville, MD 20850, United States Phone: Fax: Internet: Contact Person: Garrett Smith A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT Control Over Operations > Enhanced Productivity > Cost & Time Savings = RESULTS! FLEXIBLE SERVICE OFFERING TAILORED TO MEET YOUR NEEDS - Full CRO Services - Wholly Owned Research Dedicated Clinical Sites - Patient Management : Recruitment, Retention, Compliance - CLINICAL Call Center - Late Stage /Safety Service Recognized as 2009 s BEST CRO with a Vaccine Industry Excellence (ViE) award, Accelovance s innovative approaches have driven clinical productivity and performance within the niche market of Vaccines but also address quality, cost-savings, speed and partnering needs of other therapeutic areas. We uniquely combine our ownership of six (6) clinical research sites and internal patient management (not just recruitment, but retention and compliance also) solutions to create operational efficiencies that enhance quality, site and study productivity, and the timely delivery of research programs. We engage with Sponsors directly or through another CRO we are flexible to any working arrangement. Let s evaluate the impact we can make on your next clinical study. Let our results serve as examples of the tangible value Accelovance can bring to a Sponsor: 25-75% reduction in study/enrollment timelines 20-25% cost-savings vs. standard industry pricing Accurate Pricing = no CRO generated change orders Partnership and Commitment = communication and shared success CRO Services: flexible to meet your needs. Project Management, Regulatory Affairs, Quality Assurance, Medical Monitoring, Clinical Monitoring, Data Management, BioStatistics, Safety and Late Stage Services. Accelovance serves as an extension of your team offering these services as needed and flexible to work with other preferred vendors. Our ownership of sites gives the CRO team the additional patient and operational perspective necessary to effectively manage the study. Clinical Sites: wholly owned and research dedicated. Our six (6) clinics average 3,000 SF in size and are staffed with full time Accelovance employees. Quality is emphasized through centralized SOPs and corporate training programs. Each clinic is positioned for highly coordinated and/or high volume enrollment; offering the Sponsor predictability and performance assurances. Patient Management: more than recruitment and retention. Accelovance proactively recruits patients through its own databases, media and community outreach. Our innovative approaches pre-qualify patients prior to study start to find the right patient for the study. This planning allows for predictable, controlled and timely enrollment along with higher retention and compliance rates. Clinical Call Center: surveillance, retention, compliance. Let clinically trained agents help manage your patients through their study visit schedule and beyond. Accelovance has managed programs with 400 patients to 19,000 patients in a costeffective manner by pairing experienced agents who understand clinical research with robust technology that maximize efficiencies and reporting. Should a sponsor wish to explore an opportunity in China s rapidly growing pharmaceutical market, Accelovance China has offices in Shanghai and Beijing, PR China providing small pharma/biotech and multinational pharma companies with CRO and market registration services. Services: Clinical R&D, Data Management, Inpatient/Outpatient Facilities, Patient Compliance, Patient Recruitment, Pharmacovigilance, Project Management, Rx to OTC Switch, Trial Management, Vaccine Development visit to view our most current, searchable, online directory 1

2 Algorithme Pharma 575 Armand-Frappier Boulevard Laval, QC H7V 4B3, Canada Phone: Phone: Internet: Contact Person: George Tsolakos As a worldwide leader in clinical research and bioanalysis, Algorithme Pharma provides a wide range of services in bioequivalence and early stage development (Phase I/IIa) studies to pharmaceutical and biotechnology industries. With over 400 beds, state-of-the-art bioanalytical facilities, and 600 dedicated employees, Algorithme Pharma delivers first-class services to each client. Successfully audited by US FDA, Brazil s ANVISA, France s AFSSAPS, Canada s TPD, UK s MHRA and Austria s AGES regulatory authorities, Algorithme Pharma is committed to on-going dedication to excellence. Services: Analytical Assay Development and/or Laboratory Service, Clinical Pharmacology, Clinical R&D 2 visit to view our most current, searchable, online directory

3 HOUSE AD visit to view our most current, searchable, online directory 3

4 Almac 1040 Stony Hill Road, Suite 200 Yardley, PA 19067, United States Phone: Fax: Internet: Contact Person: Meghan Adams Take control of your clinical supply chain. ALMAC offers an integrated supply chain management solution that draws from the expertise of our best-in-class clinical trial supplies and IVR/IWR Based services. Our integrated solution does more than just combine related services under one roof; it incorporates supply planning, technology implementation, and project oversight into a unified study start-up and management approach that optimizes the supply chain at each level. How Almac manages this process Lead Almac Contact: A lead Project Manager is allocated to oversee and drive forward the project internally between both disciplines and from an inventory/drug supply management perspective. Shared Master Project Plan: All key deliverable dates are presented in a joint Project Plan, illustrating all milestones for packaging, distribution and the development/implementation of the IVRS. A clear view of the full distribution process: Almac s standardized drug ordering processes allows for consideration of shipping transit times, import licence lead times, depot management requirements and effective management of the kit lists shared between client, distribution and IVRS vendors. Integrated reporting: Almac s integrated web report utilizes data from both clinical trial supply shipping reports and distribution reports from the IVRS. This combined approach permits linkage of IVRS order numbers alongside shipping references and AWB information, providing the full life cycle of drug shipments. One single unique username and password is provided to users for the integrated web report, the clinical trial supply standard web inventory and distribution reports and the standard and customizable IVRS web reports. BENEFITS TO OUR CLIENTS Leverage of joint expertise Reduced vendor management Accelerated study start-up Rapid adaptation to study Services Our clinical technology solutions: IXRS TM (Interactive Voice and epro (Electronic Patient Reported Biostatistical Services Web Response Systems) Outcomes) Adaptive Trial Design Data Integration Clinical Hotline Our clinical trial supply solutions: Clinical trial supplies management Packaging (blistering, bottling, carding) QP release and analytical services Comparator sourcing Labeling of clinical supplies Returns, accountability and Over-encapsulation Global distribution and depot network destruction About Almac: The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company s new $100m North American Headquarters started in July 08 and is expected to be completed late To find out more about Almac visit Almac Clinical Technologies Almac Clinical Services 1040 Stony Hill Road, Suite 200, Yardley, PA Audubon Road, Audubon, PA Tel: Tel: clinicaltechnologies@almacgroup.com clinicalservices@almacgroup.com Services: Clinical Supplies/Distribution/Packaging, Clinical Trial Design, Electronic Diary/Dictionary/Translator, Project Management, Randomization (Automated/Centralized/Vocal Computer), Statistical Services/Meta Analysis 4 visit to view our most current, searchable, online directory

5 Almac Clinical Technologies 4-Color AD visit to view our most current, searchable, online directory 5

Interactive Response Technologies

Interactive 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 information

Best 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 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 information

AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE

AGILE 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 information

Equipping your Forecasting Toolkit to Account for Ongoing Changes

Equipping 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 information

PHASE IIB III. inventivhealthclinical.com

PHASE 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 information

CLINICAL DEVELOPMENT OPTIMIZATION

CLINICAL 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 information

BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015

BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015 BioWales 2015 Pharmaceutical Supply Chain Showcase 04 March 2015 SIMBEC RESEARCH 40 YEARS EXPERIENCE IN EARLY STAGE CLINICAL DRUG DEVELOPMENT BACKGROUND Over 1,200 clinical studies safely and successfully

More information

Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management Brochure More information from http://www.researchandmarkets.com/reports/2226324/ Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management Description:

More information

An 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 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 information

Meeting Priorities of Biotech & Small Pharma Companies

Meeting Priorities of Biotech & Small Pharma Companies Meeting Priorities of Biotech & Small Pharma Companies Dr. Andreas Orfanos, MBBCH,FFPM,MBA Thrasos Therapeutics Inc. Vice President Clinical Research & Development 28 Oct 2015 Montreal Technoparc Private,

More information

WHITE PAPER BUILDING THE NEXT GENERATION IRT: AN EXCLUSIVE LOOK UNDER THE HOOD OF IXRS 3

WHITE PAPER BUILDING THE NEXT GENERATION IRT: AN EXCLUSIVE LOOK UNDER THE HOOD OF IXRS 3 WHITE PAPER BUILDING THE NEXT GENERATION IRT: AN EXCLUSIVE LOOK UNDER THE HOOD OF IXRS 3 Interactive Response Technology (IRT) systems used to manage patient interactions and drug supplies during clinical

More information

THE BIOTECH & PHARMACEUTICAL INDUSTRY

THE BIOTECH & PHARMACEUTICAL INDUSTRY THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues

More information

Clinical Data Management Overview

Clinical 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 information

Life Science Sector Opportunities Northern Ireland. Clinical Trials. investni.com

Life Science Sector Opportunities Northern Ireland. Clinical Trials. investni.com Life Science Sector Opportunities Northern Ireland investni.com Introduction Clinical trials commonly refer to testing the effectiveness of experimental drugs and are typically categorised into four phases;

More information

Understanding When to Employ IVR and IWR independently or in Combination

Understanding When to Employ IVR and IWR independently or in Combination 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

More information

Needs, Providing Solutions

Needs, Providing Solutions Identifying Needs, Providing Solutions 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved

More information

Accenture Accelerated R&D Services:

Accenture Accelerated R&D Services: Accenture Life Sciences Rethink Reshape Restructure for better patient outcomes Accenture Accelerated R&D Services: Pharmacovigilance Services Overview At our company, we are focused on improving lives

More information

Optimizing the Clinical Trial Supply Chain

Optimizing 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 information

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series

Later-Stage Development: Ensuring Compliance During. for a Competitive Advantage Webinar Series Part II: Later-Stage Development: Ensuring Compliance During Clinical i l Trials Process Driven Compliance for a Competitive Advantage Webinar Series 29 September 2010 Process Driven Compliance Webinar

More information

The Evolution of Data Management Job Models. in the Execution of Clinical Trials. info@kcr.com. www.kcrcro.com

The Evolution of Data Management Job Models. in the Execution of Clinical Trials. info@kcr.com. www.kcrcro.com The Evolution of Data Management Job Models in the Execution of Clinical Trials info@kcr.com KCR S.A. Corporate Headquarters 6 Postepu str., 02-676 Warsaw Phone: +48 22 313 13 13 Fax: +48 22 313 13 14

More information

www.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS

www.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 information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

The Role of the CRO in Effective Risk-Based Monitoring

The Role of the CRO in Effective Risk-Based Monitoring New Whitepaper The Role of the CRO in Effective Risk-Based Monitoring The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging

More information

Managing the Extended Clinical Supply Chain in an Outsourced World

Managing the Extended Clinical Supply Chain in an Outsourced World Managing the Extended Clinical Supply Chain in an Outsourced World Business Pressures on Sponsors, Contractors and CROs are Increasing Most recent research on clinical trials focuses on the outsourced

More information

Case Study: Sales to Trial to Marketing Life Cycle

Case Study: Sales to Trial to Marketing Life Cycle Case Study: Sales to Trial to Marketing Life Cycle Joanne White VP of Clinical Development Chitra Sundaram Assoc. Director- Enterprise Data Warehouse PAREXEL International, LLC Over $1 Billion in Annual

More information

Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008

Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008 A Service of Indigo Research A Cipher www.indigoresearch.com Global CRO Market 2005- $15 Billion Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008 Published April 2008 CRO

More information

Engaging Clinical Trial Sites:

Engaging Clinical Trial Sites: WHITE PAPER Engaging Clinical Trial Sites: The Role of the Clinical Trial Liaison Author: MARTIN LEE, MD Vice President, Global Scientific Affairs PRA Health Sciences Key Customers in Clinical Research

More information

A clinical research organization

A clinical research organization A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced

More information

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital

Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital Position Description POSITION TITLE Project Manager TYPE OF EMPLOYMENT Full-time or part-time upto 1.0 FTE, 4 year fix term REPORTING TO a) Principal Investigator DIVISION Department of Cardiology COMPANY

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond?

Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond? Identification of Medicinal Products (IDMP) What is necessary in order to be compliant in 2016 and beyond? February 2015 Audit. Tax. Consulting. Corporate Finance. New ISO standards have been developed

More information

BioTuesday Introduction to Kendle. Philippe Moreau, CRA Manager

BioTuesday Introduction to Kendle. Philippe Moreau, CRA Manager BioTuesday Introduction to Kendle Philippe Moreau, CRA Manager March 1, 2011 Overview Top-tier CRO uniquely positioned to deliver Phases I-IV 30-year track record of delivering on client expectations Partners

More information

Validation Consultant

Validation Consultant Personal Data Name Title Validation Consultant Contact jsb-validierung Zwischen den Bächen 9 D 79618 Rheinfelden Tel: +49 7623 79 49 82 Mobile: +49 172 737 84 86 E-Mail: Internet: jsb-val@online.de http://www.jsb-validierung.de

More information

KCR Data Management: Designed for Full Data Transparency

KCR Data Management: Designed for Full Data Transparency KCR Data Management: Designed for Full Data Transparency 6% Observational 4% Phase IV 2% Device 11% Phase I 28% Phase II 49% Phase III The quality of study data relies first and foremost on the quality

More information

Drug Pooling in Clinical Trial Supply Chain

Drug 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 information

Developing a Strategy to Optimize Clinical Trial Supplies

Developing 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 information

Salary Survey 2014. Domestic, International Salary Survey and Country Cost Analysis

Salary Survey 2014. Domestic, International Salary Survey and Country Cost Analysis Salary Survey 2014 Domestic, International Salary Survey and Country Cost Analysis Disclaimer: This salary guides contained herewith have been constructed to represent average salaries across a range of

More information

Introduction. VP, Sales in a Global Courier Company

Introduction. 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 information

Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels.

Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels. Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels. 02 Clintrak knows how: Strategically engineered. Quality

More information

IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES. A trusted source for all of your global comparator needs

IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES. A trusted source for all of your global comparator needs IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES A trusted source for all of your global comparator needs WHAT YOU NEED, WHEN YOU NEED IT We typically source over 90% of comparators directly from the manufacturers

More information

2009 Foley & Lardner LLP Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative

2009 Foley & Lardner LLP Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative of clients 321 N. Clark Street, Suite 2800, Chicago, IL 60654 312.832.4500 Life

More information

Catalent Biologics & Clinical Supplies The SMART Solution

Catalent Biologics & Clinical Supplies The SMART Solution Catalent Biologics & Clinical Supplies The SMART Solution Advanced Technology and Integrated Solutions From DNA to Clinical Supply & Cold Chain Distribution Dr. Florian Schwaak Account Manager Germany

More information

Clinical Supply Chain Management Driving Operational Performance

Clinical Supply Chain Management Driving Operational Performance Clinical Supply Chain Management Driving Operational Performance July 2010 PwC Your presenters EER1 Ellen Reilly Managing Director Pharma & Life Sciences Advisory Services 400 Campus Drive Florham Park,

More information

eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Drug Supply Chain Forms Library Data Collection Services

eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Drug Supply Chain Forms Library Data Collection Services eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Data Collection Services Drug Supply Chain Forms Library Real-time Data Access Clinical Data Management Electronic

More information

Comprehensive Sample Management Solutions

Comprehensive Sample Management Solutions Comprehensive Sample Management Solutions Discover the Hidden Value in Your Sample Assets solutions consulting sample storage sample bioprocessing onsite/offsite operations management logistics/relocation

More information

What We Are..! www.ardent-cro.com

What We Are..! www.ardent-cro.com Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: ardent@ardent-cro.com Web: What We Are..! Ardent Clinical Research Services is

More information

RAPS ONLINE UNIVERSITY

RAPS ONLINE UNIVERSITY RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.

More information

Document and Quality Management Solutions for Life Sciences

Document and Quality Management Solutions for Life Sciences Document and Quality Management Solutions for Life Sciences Company Overview Global Provider Established US and European footprint Proven Solution SharePoint based document and quality management. Solutions

More information

Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034. Phone: 267.468.8560 Fax: 267.468.

Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034. Phone: 267.468.8560 Fax: 267.468. Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATE in CLINICAL TRIAL MANAGMENT Designed for Pharmaceutical

More information

Clinical Trial Logistics

Clinical Trial Logistics Company Brochure Clinical Trial Logistics contents 1. 2. 3. 4. 5. 6. About us Values Facility Quality Management System Services Why PCS Clinical Trial Logistics about us MEET US PHARMA COMPLEX SOLUTIONS

More information

Supply Chain Challenges and Risk Management

Supply Chain Challenges and Risk Management Supply Chain Challenges and Risk Management Presented by Steve Williams Director SeerPharma P/L 21 st April 2009 PDA April 09 SW 1 Supply Chain - Some Useful Guidance cgmp Annex 8 cgmp Chapter 7 ICH Q7

More information

Streamlining clinical trial supply management

Streamlining 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 information

Minimize overspend by gaining visibility of total demand

Minimize 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 information

APAC Contract Research Organisation (CRO) Market

APAC Contract Research Organisation (CRO) Market Brochure More information from http://www.researchandmarkets.com/reports/3308444/ APAC Contract Research Organisation (CRO) Market Description: The research service presents an overview and analysis of

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA 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 information

Clinical TOTAL CLINICAL THE COMPLETE CLINICAL CLOUD. Clinical on the Cloud. Total. Clinical Data Management. Operations. Clinical

Clinical TOTAL CLINICAL THE COMPLETE CLINICAL CLOUD. Clinical on the Cloud. Total. Clinical Data Management. Operations. Clinical Powe r i n g C l i n i c a l D eve l o p m e n t f r o m C o n c e p t t o C o m m e r c i a l S u c c e s s Data on CLINICAL RESEARCH SUCCESS Company efforts to speed development, boost success rates,

More information

Safety Is Global: Contemporary Pharmacovigilance and Medical Product Risk Management Strategies

Safety Is Global: Contemporary Pharmacovigilance and Medical Product Risk Management Strategies Safety Is Global: Contemporary Pharmacovigilance and Medical Product Risk Management Strategies CLICK HERE to register. PROGRAM COMMITTEE WHO SHOULD ATTEND This program will benefit professionals with

More information

Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management

Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Reference Code: GBIHC088MR Publication Date: June 2011 Biopharmaceutical companies

More information

NEW CHEMICAL ENTITIES

NEW CHEMICAL ENTITIES NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product

More information

Global healthcare solutions

Global healthcare solutions Global healthcare solutions clinical trials pharma/biotech medical technology & supplies Global healthcare solutions for your peace-of-mind A global network with specialist options Global presence with

More information

Medical Device Solutions. Battelle. Applied Research Device Development Clinical Research Sustaining Engineering

Medical Device Solutions. Battelle. Applied Research Device Development Clinical Research Sustaining Engineering Medical Device Solutions Battelle Applied Research Device Development Clinical Research Sustaining Engineering 0 2 Overview Applied Research Device Development Clinical Research Sustaining Engineering

More information

IXRS Interactive Voice and Web Response System. MTN Annual Meeting ASPIRE Trial

IXRS 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 information

Clinical Trial Management Systems Survey

Clinical Trial Management Systems Survey Clinical Trial Management Systems Survey Conducted: January 2013 : Cambridge Healthtech Media Group 250 First Avenue, Suite 300, Needham, Massachusetts 02494 T: 781-972-5400 or toll-free in the U.S. 888-999-6288

More information

Leveraging SharePoint for Clinical Trial Management

Leveraging SharePoint for Clinical Trial Management Bringing your projects to a higher level SM Leveraging SharePoint for Clinical Trial Management 26 April 2011 Presented by Darcy Vieira, Cato Research Canada Jeremiah Rehm, BioClinica 1 2010 by Cato Research

More information

BIOCLINICA, INC. TO DEMONSTRATE TECHNOLOGY-ENHANCED CAPABILITIES AT UPCOMING GLOBAL INDUSTRY EVENTS

BIOCLINICA, INC. TO DEMONSTRATE TECHNOLOGY-ENHANCED CAPABILITIES AT UPCOMING GLOBAL INDUSTRY EVENTS Company Contact - Jim Dorsey BioClinica, Inc. 267-757-3040 Trade Media Morgan Dub Karpo Diccicco Battista Communications 484-342-3600 FOR IMMEDIATE RELEASE BIOCLINICA, INC. TO DEMONSTRATE TECHNOLOGY-ENHANCED

More information

Statistical Operations: The Other Half of Good Statistical Practice

Statistical Operations: The Other Half of Good Statistical Practice Integrating science, technology and experienced implementation Statistical Operations: The Other Half of Good Statistical Practice Alan Hopkins, Ph.D. Theravance, Inc. Presented at FDA/Industry Statistics

More information

APAC CRO Market A deep dive into the trends transforming APAC CRO industry. P86A-52 June 2015

APAC CRO Market A deep dive into the trends transforming APAC CRO industry. P86A-52 June 2015 APAC CRO Market A deep dive into the trends transforming APAC CRO industry June 2015 Table of Contents Section Slide Numbers Executive Summary 10 Key Findings 11 Total CRO Market Size By Stages of Clinical

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information

Clinical Trial Supply Chain Driving Transformation for Excellence

Clinical Trial Supply Chain Driving Transformation for Excellence Clinical Trial Supply Chain Driving Transformation for Excellence October 20, 2009 2009 AMR Research, Inc. Page 1 Key Success Criteria of Life Sciences Companies Q84. What are your company s key success

More information

PharmAssess Audit Reports Operational Consultancy GMP Auditing Services Regulatory Affairs. www.rephine.com

PharmAssess Audit Reports Operational Consultancy GMP Auditing Services Regulatory Affairs. www.rephine.com PharmAssess Audit Reports Operational Consultancy GMP Auditing Services Regulatory Affairs www.rephine.com The Market Leader in GMP Audit Reporting PharmAssess audit reports are accepted by all Regulatory

More information

Clinical Trial Management Software

Clinical 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 information

Workshop on Quality Risk Management Making Trials Fit for Purpose

Workshop on Quality Risk Management Making Trials Fit for Purpose Clinical Trials Transformation Initiative Workshop on Quality Risk Management Making Trials Fit for Purpose Andy Lee SVP, Global Clinical Operations, Genzyme Corporation August 23/24, 2011 Hyatt Regency,

More information

Lorna Briddick Managing Partner Brizzey LLC. 10/30/2014 October 30, 2014 1

Lorna 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 information

INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH Background and Company Performance Industry Challenges esource: Electronic Clinical Trial Solution Clinical trial sponsors and clinical research organizations

More information

How To Write A Paper On The Clinical Trial Coding Process

How To Write A Paper On The Clinical Trial Coding Process WHITE PAPER Clinical Trial : Overcoming the Challenges through Automation within Electronic Data Capture Applications WHITE PAPER Abstract: This paper reviews the issues surrounding the clinical trial

More information

Clinical Trial Trends Outline Complexity for Supply Chain. Scott Ohanesian, VP Commercial Operations APAC Email: Scott.Ohanesian@marken.

Clinical Trial Trends Outline Complexity for Supply Chain. Scott Ohanesian, VP Commercial Operations APAC Email: Scott.Ohanesian@marken. Clinical Trial Trends Outline Complexity for Supply Chain Scott Ohanesian, VP Commercial Operations APAC Email: Scott.Ohanesian@marken.com 29 May 2013 Biotechnology Sales on the Rise Source: EvaluatePharma

More information

Adjudication in Oncology Trials: A Concept Whose Time Has Come

Adjudication in Oncology Trials: A Concept Whose Time Has Come Adjudication in Oncology Trials: A Concept Whose Time Has Come By WorldCare Clinical: Richard Walovitch, PhD, Chief Medical Officer, Asli Memisoglu, ScD, Director of Biostatistics and Data Management,

More information

Increasing Clinical Trial Data Management Efficiencies by Utilizing a Satellite Office Model

Increasing Clinical Trial Data Management Efficiencies by Utilizing a Satellite Office Model Increasing Clinical Trial Data Management Efficiencies by Utilizing a Satellite Office Model For pharmaceutical, biotechnology, and device companies (Sponsors) seeking increased efficiencies from their

More information

Practical Applications for Clinical Demand and Operations Planning

Practical 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 information

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate

More information

ORACLE HEALTH SCIENCES INTERACTIVE RESPONSE TECHNOLOGY (IRT)

ORACLE 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 information

Plan and manage clinical trials with clarity and confidence

Plan and manage clinical trials with clarity and confidence Plan and manage clinical trials with clarity and confidence Accurately identify opportunities and avoid obstacles throughout the clinical trial process with IMS Health Clinical Trial Optimization Solutions

More information

Innovations in Pharma Sales Operations

Innovations in Pharma Sales Operations Innovations in Pharma Sales Operations Sales Ops Importance in Pharma Pharmaceutical organizations are going through fundamental restructuring. They are facing changing regulations, intense cost pressure,

More information

through advances in risk-based

through 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 information

PROJECT MANAGEMENT AS A CAREER PATH FOR PHDS: PERSPECTIVE FROM BIOTECH AND NONPROFIT SECTORS

PROJECT MANAGEMENT AS A CAREER PATH FOR PHDS: PERSPECTIVE FROM BIOTECH AND NONPROFIT SECTORS PROJECT MANAGEMENT AS A CAREER PATH FOR PHDS: PERSPECTIVE FROM BIOTECH AND NONPROFIT SECTORS Sanya Fanous Whitaker Scientific Program Manager Foundation for the National Institutes of Health June 26, 2015

More information

TRANSFORMING LIFE SCIENCES THROUGH ENTERPRISE ANALYTICS

TRANSFORMING 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 information

A Comparison of Two Commonly Used CRO Resourcing Models for SAS/ Statistical Programmers R. Mouly Satyavarapu, PharmaNet/ i3, Ann Arbor, MI

A Comparison of Two Commonly Used CRO Resourcing Models for SAS/ Statistical Programmers R. Mouly Satyavarapu, PharmaNet/ i3, Ann Arbor, MI PharmaSUG 2012 - Paper MS11 A Comparison of Two Commonly Used CRO Resourcing Models for SAS/ R. Mouly Satyavarapu, PharmaNet/ i3, Ann Arbor, MI ABSTRACT: Why do we have Contract Research Organizations

More information

SAS Drug Development User Connections Conference 23-24Jan08

SAS Drug Development User Connections Conference 23-24Jan08 SAS Drug Development User Connections Conference 23-24Jan08 Bernd Doetzkies David Ramage Daiichi Sankyo Pharma Development DSPD Clinical Data Repository System Business Drivers System Overview People and

More information

ASCO. R&D Supply Chain and Clinical Trials Supply Management A Life Sciences Solution. Award for the "Best Business Transformation project 2010

ASCO. 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 information

Clinical Supply Chain Management. Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

Clinical Supply Chain Management. Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management Clinical Supply Chain Management Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management GBI Research Report Guidance GBI Research Report Guidance The report focuses on the current

More information

Trial Master File Reference Model User Guide V 1.0

Trial Master File Reference Model User Guide V 1.0 Trial Master File Reference Model User Guide V 1.0 16 June 2015 Table of Contents 1. PURPOSE OF THE GUIDE... 3 2. LAYING THE GROUNDWORK... 4 3. PROCESS... 5 3.1 Developing a Business Case... 6 3.2 Plan

More information

Discover more, discover faster. High performance, flexible NLP-based text mining for life sciences

Discover more, discover faster. High performance, flexible NLP-based text mining for life sciences Discover more, discover faster. High performance, flexible NLP-based text mining for life sciences It s not information overload, it s filter failure. Clay Shirky Life Sciences organizations face the challenge

More information

Mark Rohlfing. Vice President of Operations Almac Clinical Services Souderton, Pennsylvania

Mark Rohlfing. Vice President of Operations Almac Clinical Services Souderton, Pennsylvania Mark Rohlfing Vice President of Operations Almac Clinical Services Souderton, Pennsylvania Confidential Almac Group 2014 Who We Are Almac is a global drug development services provider. Our mission is

More information

Global Clinical Supplies Regional Leads EPICS SEPTEMBER 20, 2010

Global Clinical Supplies Regional Leads EPICS SEPTEMBER 20, 2010 Global Clinical Supplies Regional Leads EPICS SEPTEMBER 20, 2010 Discussion Points Background on the Regional Leads Purpose of the Regional Leads Key Roles & Responsibilities Examples & Case Studies Global

More information

How to Utilize an IVRS for Efficient Management of Clinical Supplies

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 information

strategy Therapure Biopharma is open for business P.20 HOW TO CHOOSE INSIGHTS FOR THE LIFE SCIENCE INDUSTRY DECEMBER 2008 Volume 11 Number 12

strategy Therapure Biopharma is open for business P.20 HOW TO CHOOSE INSIGHTS FOR THE LIFE SCIENCE INDUSTRY DECEMBER 2008 Volume 11 Number 12 INSIGHTS FOR THE LIFE SCIENCE INDUSTRY DECEMBER 2008 Volume 11 Number 12 Therapure Biopharma is open for business P.20 HOW TO CHOOSE THE RIGHT outsourcing providers for your oncology clinical trials outsourcing

More information

Even we will get to use your product someday. Enough reason for us to deliver.

Even we will get to use your product someday. Enough reason for us to deliver. Even we will get to use your product someday. Enough reason for us to deliver. ClinInvent: Putting our heart and soul behind the research. At ClinInvent, when we talk about clinical research it s not just

More information

End to end Clinical Trial Supply Management with SAP

End 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 information

Logistics. Drug Pooling in the Clinical Trial Supply Chain

Logistics. 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 information