BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015

Size: px
Start display at page:

Download "BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015"

Transcription

1 BioWales 2015 Pharmaceutical Supply Chain Showcase 04 March 2015

2 SIMBEC RESEARCH 40 YEARS EXPERIENCE IN EARLY STAGE CLINICAL DRUG DEVELOPMENT BACKGROUND Over 1,200 clinical studies safely and successfully completed ~40% First-in-Human NCE/biologics including multi-part / umbrella protocols OPERATIONAL 58 bed clinical pharmacology unit Central laboratory services γ-scintigraphy imaging services Integrated Data Management and Statistics, Project Management & Medical Writing Pharmacy and Qualified Person (QP) QA Unit MEDICAL 4 full time Physicians and 1 part-time screening Physician All Physicians, Research Nurses, Physiologists and Technicians, ILS or ALS trained Study specific Risk Management Plan is prepared for every study Emergency Scenario Training including first response rapid resuscitation kit and agreements with local Welsh Ambulance Service Trust & Prince Charles Hospital

3 MAY MARCH 2014 BACK FROM THE BRINK Simbec Research was on the brink of collapse the business had been sold to an owner which wanted to undertake cheap, low cost, bioequivalence studies 100 Welsh jobs were at risk Through the determination of Howard Jenkins and Dr Trevor Tanner the business was saved Prof Sir Chris Evans with his team at Arthurian Life Sciences recapitalise the business through the Wales Life Sciences Fund Prof Trevor Jones agreed to become Chairman In the next 10 months the business got back on track growing 30% in one year and stopped losing money But, where should it go from there

4 MARCH 2014 MARCH 2015 AND WHAT A YEAR IT S BEEN! In a private room at BioWales 2014 Simbec s board held a meeting we agreed to back the acquisition of Orion Clinical Services, and agreed succession planning for the board In June 2014 the merger of Simbec Research and Orion Clinical was agreed, backed by the Wales Life Sciences Fund & HSBC The merger created a Welsh HQ d, international, full service CRO Integration was completed rapidly and we now have an international team Today we have depth, specialty and the power to meet our clients needs

5 FULL SERVICE CRO FROM THE FIRST DOSE IN MAN TO THE LAST DOSE PRE-REGISTRATION PHASE I I V DATA MANAGEMENT & STATISTICS MEDICAL MONITORING IMP MANAGEMENT drug labeling, release, tracking recall, accountability, QP PHARMACOVIGILANCE Clinical trials & post-marketing REGULATORY AFFAIRS & TECHNICAL WRITING QUALITY ASSURANCE CENTRAL LABS Bioanalytic & Pathology

6 GLOBAL RESOURCES WE HAVE THE REACH TO DELIVER FOR ANY CLIENT >30 COUNTRIES CLINICAL MONITORING SERVICES OFFICES MONITORS

7 THERAPEUTIC FOCUS CONCENTRATE ON OUR AREAS OF EXCELLENCE ONCOLOGY RARE & ORPHAN RESPIRATORY DERMATOLOGY INFECTIOUS DISEASE TRANSLATIONAL MEDICINE

8 A YEAR IN REVIEW WE ARE GRATEFUL FOR Winning Phase I healthy volunteer studies from Orion-pre merger clients Winning two major international Phase III studies in Non-Small Cell Lung Cancer and Systemic Lupus Erythematosus (SLE) Executed the first two partnership agreements taking equity in our clients Secured major Central Lab business via our Phase II, III and IV business Created our IMP Management Group from Simbec s Pharmacy to be capable of handling for international Phase II, III and IV studies internationally No staff are now employed below Living Wage and we have a commitment to improve standards further We have consolidated our administrative operations in Wales taking advantage of the talent pool available We are attracting new talent to the Group: recruiting World class scientific talent back to Merthyr Tydfil and securing senior leadership internationally We now compete with businesses multiple times our physical size So what s next?

9 ETHOS OUR CLIENTS ARE OUR PARTNERS We have a simple principle - while we provide outsourced service We Think Like Drug Developers

10 SIMBEC-ORION A HERITAGE OF CLINICAL RESEARCH 1976 ESTABLISHED one of the oldest clinical research service provider in the world 40 YEARS EXPERIENCE AND EXPERTISE PHASE I- IV FULL CONTINUUM OF PHASE 1 - IV SERVICES to follow your molecule from early phase to post-marketing >1,500 (phase I-IIa) >500 (phase I-IV) NICHE EXPERTISE FULL SUITE OF SERVICES PLANNED AND CONDUCTED more than 1,500 Early Phase (Phase 1-11a) studies SUCCESSFUL DELIVERY more than 500 Phase II-IV studies IN A SERIES OF HIGHLY FOCUSED AREAS Oncology, Rare & Orphan, Respiratory, Dermatology, Infectious disease, and Translational Medicine PV, IMP, DM, STATS, MED Wr, REG AFFAIRS QA, CENT LABS,

Simbec Research Limited ( Simbec ) and ORION Clinical Services Limited ( ORION )

Simbec Research Limited ( Simbec ) and ORION Clinical Services Limited ( ORION ) Simbec Research Limited ( Simbec ) and ORION Clinical Services Limited ( ORION ) Merger of Simbec & ORION to Create a New International Full-Service CRO Highlights: Creation of an international CRO with

More information

Job Profile Clinical Research Associate I/II (CRA)

Job Profile Clinical Research Associate I/II (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

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

Annex 7 Guidelines for the preparation of a contract research organization master file

Annex 7 Guidelines for the preparation of a contract research organization master file World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 7 Guidelines for the preparation of a contract research organization master file Background 1. General information 2. Quality

More information

Monika Panayotova. Comac Medical BILATERAL MEETINGS DESCRIPTION

Monika Panayotova. Comac Medical BILATERAL MEETINGS DESCRIPTION Monika Panayotova BUSINESS DEVELOPMENT Comac Medical http://www.comac-medical.com BILATERAL MEETINGS Thursday (1:30pm 6:00pm) DESCRIPTION Comac Medical is a full-service, boutique, Contract Research Organization

More information

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient

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

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

A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT

A 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 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

PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES

PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES PPD LABORATORIES CENTRAL LAB: SUPERIOR SERVICE, QUALITY DATA WITHOUT COMPROMISES PPD Laboratories provides world-class scientific expertise with state-of-the-art technologies supported by a commitment

More information

From The Lab To Your Medicine Cabinet:

From The Lab To Your Medicine Cabinet: From The Lab To Your Medicine Cabinet: A Pharmaceutical Drug s Journey Presented by: Dr. Steven Hansel Sr. Director; Pfizer Moderated by: Sam Gilchrist Ph.D. Candidate; UBC The Drug Development Process

More information

Monash University - Master of Clinical Pharmacy

Monash University - Master of Clinical Pharmacy Monash University - Master of Clinical The Master of Clinical is a 48 credit point program, equivalent to one year of full time study (generally completed in 2 years part time). It comprises 1200 hours

More information

Orphan Pharma: pathfinders for an increasingly specialised industry

Orphan Pharma: pathfinders for an increasingly specialised industry Orphan Pharma: pathfinders for an increasingly specialised industry Foreword We are continuing our series by profiling the R&D and Clinical Development leadership of European and North American specialty

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

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this

More information

Execution in Clinical Research

Execution in Clinical Research TM TM Execution in Clinical Research Execution - a key driver for success Medpace, long known for its excellence in conducting Phase I-IV studies on a global platform, is particularly noted for its therapeutic

More information

m 4 Biobank Alliance & m 4 Trial Service Center

m 4 Biobank Alliance & m 4 Trial Service Center m 4 Biobank Alliance & m 4 Trial Service Center Services & Consulting in (non-)clinical development www.m4.de m 4 Biobank Alliance Central Access to High Quality Human Biospecimens for R&D The m 4 Biobank

More information

THE LINCOLN INSTITUTE OF HEALTH

THE LINCOLN INSTITUTE OF HEALTH THE LINCOLN INSTITUTE OF HEALTH Background The Chair in the Care of the Older Person will be part of the new Lincoln Institute of Health, a cross disciplinary research collaboration linking schools, colleges

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

Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services

Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services Providing a wide range of clinical research services Abt Associates Clinical Trials (AACT) is dedicated to providing

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

Once a new drug is discovered, there is a specific series of steps it must go through to acquire FDA approval. Before any applications are sent to the

Once a new drug is discovered, there is a specific series of steps it must go through to acquire FDA approval. Before any applications are sent to the Research Primer: Introduction to the FDA Drug Approval Process and Off Label Use BRITTANY LA COUTURE OCTOBER 22, 2015 Introduction The United States is home to the majority of the world s new drug developers.

More information

Key considerations for outsourcing late phase clinical research

Key considerations for outsourcing late phase clinical research Key considerations for outsourcing late phase clinical research Alan Nelson (on behalf of Van Zyl Engelbrecht) Senior Project Director at UBC: An Express Script Company Layout of presentation My presentation

More information

5 Health Care Pathways

5 Health Care Pathways Health Care Careers 5 Health Care Pathways All Health Care occupations are organized into 5 pathways. THERAPEUTIC SERVICES DIAGNOSTIC SERVICES HEALTH INFORMATICS SUPPORT SERVICES BIOTECHNOLOGY RESEARCH

More information

The Promise and Challenge of Adaptive Design in Oncology Trials

The Promise and Challenge of Adaptive Design in Oncology Trials THE POWER OFx Experts. Experience. Execution. The Promise and Challenge of Adaptive Design in Oncology Trials Clinical oncology trials are more complex and time consuming than those in any other therapeutic

More information

Medical and Other Staff Pay and Grading Structures

Medical and Other Staff Pay and Grading Structures Medical and Other Staff Pay and Grading Structures Associate Specialist Associate Specialist 36,769.00 to 79,756.00 Locum Associate Specialist Associate Specialist - Disc Pnts 36,769.00 to 79,756.00 Consultant

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

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

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

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies Innovative Drug Research and Development in Russia 2012 OCT: CRO in Russia, Central and Eastern Europe Russian Innovative

More information

U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade. N8B7-52 December 2010

U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade. N8B7-52 December 2010 U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade December 2010 Table of Contents Notes on Methodology 8 Market Introduction and Segmentation Introduction

More information

The Evolving Role of Nurses in Early Phase Research

The Evolving Role of Nurses in Early Phase Research U.S. Department of Health and Human Services The Evolving Role of Nurses in Early Phase Research Clare Hastings, RN, PhD, FAAN Chief Nurse Officer, Clinical Center April 27, 2012 Discover America s Research

More information

NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1

NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1 NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1 2 The National Agency of Drug and Food Control (NA-DFC) is a non departmental

More information

Research on Research: Learning about Phase 1 Trials

Research on Research: Learning about Phase 1 Trials CLINICAL CASE STUDY SERIES Research on Research: Learning about Phase 1 Trials Phases of clinical trial investigation are described in some detail in the Code of Federal Regulations. Phase 1 is described

More information

Addressing forecasted oncologist shortage: A Cancer Education Program for Pharmacy Students (CEPPS)

Addressing forecasted oncologist shortage: A Cancer Education Program for Pharmacy Students (CEPPS) Addressing forecasted oncologist shortage: A Cancer Education Program for Pharmacy Students (CEPPS) Dr. Department of Pharmacy Practice State University of New York School of Pharmacy and Pharmaceutical

More information

Enabling Elastic Capacity for Integration and Data Harmonization through Cloud-based Services

Enabling Elastic Capacity for Integration and Data Harmonization through Cloud-based Services B ROC H U R E Enabling Elastic Capacity for Integration and Data Harmonization through Cloud-based Services Summary Pharmaceutical and healthcare companies, like others, must continually innovate in order

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

Clinical Trial Operations

Clinical Trial Operations Contract Research and Consulting Organisation Consulting Clinical Trial Operations Training Your partner for CLINically remarkable results We are a leading Polish company specializing in clinical research

More information

Nurse Researcher or Clinical Research Nurse: Understanding the Difference

Nurse Researcher or Clinical Research Nurse: Understanding the Difference Nurse Researcher or Clinical Research Nurse: Understanding the Difference Claudia D. Smith, PhD, RN, NE-BC Director, Nursing Research St. Luke s Medical Center An Alternate Title for the Presentation:

More information

Key Findings. Use this report to... The Top 10 Contract Research Organizations

Key Findings. Use this report to... The Top 10 Contract Research Organizations Key Findings The global CRO industry valued $18bn in 2008, an increase of 14% over 2007. The CRO market will grow at an annual rate of 14% over the 2009 13 period. Quintiles leads the global CRO market

More information

CTC Technology Readiness Levels

CTC Technology Readiness Levels CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

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

Course Curriculum for Master Degree in Clinical Pharmacy

Course Curriculum for Master Degree in Clinical Pharmacy Course Curriculum for Master Degree in Clinical Pharmacy The Master Degree in Clinical Pharmacy is awarded by the Faculty of Graduate studies at Jordan University of Science and Technology (JUST) upon

More information

BioWorld s PARTNER in FOCUS: Covance AN ADVERTISING SERVICE FROM BIOWORLD

BioWorld s PARTNER in FOCUS: Covance AN ADVERTISING SERVICE FROM BIOWORLD BioWorld s PARTNER in FOCUS: Covance AN ADVERTISING SERVICE FROM BIOWORLD PARTNERING Trend Allows Smart CROs TO Provide Gamut of Services TO Any Size COMPANy Five years ago, contract research organizations

More information

We set things in motion and keep them moving. Metronomia Clinical Research Services

We set things in motion and keep them moving. Metronomia Clinical Research Services We set things in motion and keep them moving Metronomia Clinical Research Services Our customers love the fact that we keep up with their individual tempos. Dorothea Wessiepe, Director Biostatistics Metronomia:

More information

The Clinical Research Profession in India India is emerging as a global hub for clinical research. According to projections

The Clinical Research Profession in India India is emerging as a global hub for clinical research. According to projections By 2008, up to 30% of global clinical trials will take place outside the U.S. and western Europe, and India has emerged as a favorable destination for these trials. Umakanta Sahoo, PhD, MBA Dipti Sawant,

More information

Materials Management Overview

Materials Management Overview Partners HealthCare Overview Materials Management Overview Procurement Activity ACA Impact on Procurement 2 3 PARTNERS HEALTHCARE OVERVIEW Partners HealthCare System Incorporated was founded in 1994 by

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

CANCER LEADERSHIP COUNCIL

CANCER LEADERSHIP COUNCIL CANCER LEADERSHIP COUNCIL A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS ADDRESSING PUBLIC POLICY ISSUES IN CANCER March 27, 2015 The Honorable Fred Upton Chairman, Committee on Energy & Commerce

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

GIORGIO VITTORIO SCAGLIOTTI, M.D. CURRICULUM VITAE

GIORGIO VITTORIO SCAGLIOTTI, M.D. CURRICULUM VITAE GIORGIO VITTORIO SCAGLIOTTI, M.D. CURRICULUM VITAE Personal Information Date of birth July 2, 1953 Place of birth Torino, Italy Office address Department of Oncology S. Luigi Gonzaga Hospital, Oncology

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

SCORR Marketing and Applied Clinical Trials Mobile Health in Clinical Trials Survey Report

SCORR Marketing and Applied Clinical Trials Mobile Health in Clinical Trials Survey Report SCORR Marketing and Applied Clinical Trials Mobile Health in Clinical Trials Survey Report Overview Mobile health continues to be a hot topic in the drug development services industry as companies explore

More information

Health Care Job Information Sheet #20. Clinical Research

Health Care Job Information Sheet #20. Clinical Research Health Care Job Information Sheet #20 Clinical Research A. Background B. Occupations 1) Clinical Research Associate (Study Monitor) 2) Clinical Research Coordinator 3) Other positions in the field C. Labour

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

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

Effective Outsourcing of Clinical Pharmacology Studies in Europe. John Horkulak Executive Director, Eurasian External Clinical Study Operations

Effective Outsourcing of Clinical Pharmacology Studies in Europe. John Horkulak Executive Director, Eurasian External Clinical Study Operations Effective Outsourcing of Clinical Pharmacology Studies in Europe John Horkulak Executive Director, Eurasian External Clinical Study Operations Key Questions Do clinical pharmacology studies require a different

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

The Sage Group and Talentmark Consulting Announce Strategic Alliance for Services to the Global Healthcare & Life Sciences Industry

The Sage Group and Talentmark Consulting Announce Strategic Alliance for Services to the Global Healthcare & Life Sciences Industry Talentmark Consulting Product Driven People Solutions Press Release The Sage Group and Talentmark Consulting Announce Strategic Alliance for Services to the Global Healthcare & Life Sciences Industry Cambridge

More information

Specialty Pharmacy? Disclosure. Objectives Technician

Specialty Pharmacy? Disclosure. Objectives Technician Disclosure What s so SPECIAL about? I have no actual or potential conflict of interest in relation to this program/presentation. Michael DeCoske, PharmD, BCPS Associate Chief Pharmacy Officer Duke University

More information

Unlock Your Global Business Potential: Supporting Life Sciences in the UK

Unlock Your Global Business Potential: Supporting Life Sciences in the UK Unlock Your Global Business Potential: Supporting Life Sciences in the UK Dr Mark Treherne, Chief Executive, Life Science Investment Organisation Health Research Authority 31 st March, 2014 THE UK HAS

More information

A Greater Understanding. A Practical Guide to Clinical Trials

A Greater Understanding. A Practical Guide to Clinical Trials A Greater Understanding A Practical Guide to Clinical Trials Solving Insurance and Healthcare AccessProblems I since 1996 A Greater Understanding Patient Advocate Foundation MISSION STATEMENT Patient Advocate

More information

HEALTHCARE TRANSACTIONS: Year in Review

HEALTHCARE TRANSACTIONS: Year in Review HEALTHCARE TRANSACTIONS: Year in Review JANUARY 2016 OVERVIEW The explosive rate of healthcare mergers and acquisitions in 2015 reveals the importance of collaboration and integration across all sectors.

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

PHARMACY TECHNICIAN SERIES

PHARMACY TECHNICIAN SERIES PHARMACY TECHNICIAN SERIES Occ. Work Prob. Effective Last Code No. Class Title Area Area Period Date Action 4058 Pharmacy Technician I 12 446 6 mo. 02/15/04 Revised 4059 Pharmacy Technician II 12 446 6

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH 2013 Frost & Sullivan 1 We Accelerate Growth Entrepreneurial Company of the Year Award Pharmaceutical Knowledge Process Outsourcing North America, 2013 Frost & Sullivan s Global Research Platform Frost

More information

Timely Access to Quality Health Care

Timely Access to Quality Health Care Media Backgrounder Timely Access to Quality Health Care Timely Access to Quality Health Care As a Province, we have much to show for our unwavering commitment to health care: The number of physicians practicing

More information

Overview of Drug Development: the Regulatory Process

Overview of Drug Development: the Regulatory Process Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger

More information

ROLE DESCRIPTIONS BY COMPETENCY LEVEL

ROLE DESCRIPTIONS BY COMPETENCY LEVEL Description of Work: Positions in this class provide patient evaluation and care in area of assignment. Duties include but are not limited to development and presentation of educational programs, assessment,

More information

What is the Career + Compensation Program?

What is the Career + Compensation Program? The Career and Compensation Program (CCP) is a new pay and career framework designed to enhance the University's Canes What is the Career + Compensation Program? Total Rewards package by providing the

More information

Chemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

Chemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom Chemicals and Life Sciences Industry Practice Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom i Insurance and compensation in the event of injury in Phase

More information

Strategy Planning Management Execution Analysis

Strategy Planning Management Execution Analysis Leading the way Strategy Planning Execution Analysis 1 Excellence in Delivery ICON is a division of ICON plc. It specializes in the planning management, execution, and analysis of Phase IIb IV clinical

More information

Draft Guidance for Industry Premarketing Risk Assessment

Draft Guidance for Industry Premarketing Risk Assessment Draft Guidance for Industry Premarketing Risk Assessment [Docket Number 2004D-0187] Submitted to the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

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

Performance Profile. Clinical Study Physician. www.celyad.com 1

Performance Profile. Clinical Study Physician. www.celyad.com 1 Performance Profile Clinical Study Physician www.celyad.com 1 Role: Provide medical guidance and leadership throughout the development and conduct of clinical trials. You will be responsible for overseeing

More information

Ask Us About Clinical Trials

Ask Us About Clinical Trials Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing

More information

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical

More information

Case: 1:69-cv-02145 Document #: 3977-2 Filed: 10/22/14 Page 1 of 8 PageID #:26731 EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST

Case: 1:69-cv-02145 Document #: 3977-2 Filed: 10/22/14 Page 1 of 8 PageID #:26731 EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST Case: 1:69-cv-02145 Document #: 3977-2 Filed: 10/22/14 Page 1 of 8 PageID #:26731 EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST Administrative Analyst V Administrative Director ADMINISTRATIVE DIRECTOR-DEPT

More information

Insurance and compensation in the event of injury in Phase I clinical trials

Insurance and compensation in the event of injury in Phase I clinical trials Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical

More information

Harmonized Core Competencies in Clinical Research: evolutions and next steps for meeting the challenge

Harmonized Core Competencies in Clinical Research: evolutions and next steps for meeting the challenge Harmonized Core Competencies in Clinical Research: evolutions and next steps for meeting the challenge Master of Applied Clinical and Preclinical Research macpr.osu.edu Consortium of Academic Programs

More information

Continuing education for community pharmacists in Denmark the case of Master of Drug Management

Continuing education for community pharmacists in Denmark the case of Master of Drug Management Continuing education for community pharmacists in Denmark the case of Master of Drug Management Birthe Søndergaard Associate Professor Department of Pharmacology and Pharmacotherapy, Section of Social

More information

MEDICAL DIRECTOR: ROLE AND RESPONSIBILITIES AS LEADER AND MANAGER

MEDICAL DIRECTOR: ROLE AND RESPONSIBILITIES AS LEADER AND MANAGER MEDICAL DIRECTOR: ROLE AND RESPONSIBILITIES AS LEADER AND MANAGER FUNCTIONS AND ASSOCIATED TASKS Function 1 - Administrative The medical director participates in administrative decision making and recommends

More information

The Top 10 Contract Research Organizations

The Top 10 Contract Research Organizations OUTSOURCING The Top 10 Contract Research Organizations Positioning, performance and SWOT analyses Table of Contents Copyright 2009 Business Insights Ltd This Management Report is published by Business

More information

EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1

EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1 EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1 October 4, 2005 Guideline on Risk Management Systems for Medicinal Products for Human Use DRAFT London, 6 September 2005. This guideline will be included as chapter

More information

COVANCE INC. NYSE: CVD

COVANCE INC. NYSE: CVD COVANCE INC. NYSE: CVD JOE HERRING CHAIRMAN AND CEO June 3, 2014 Safe Harbor Statements contained in this press release, which are not historical facts, such as statements about prospective earnings, savings,

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

Health Science Career Field Allied Health and Nursing Pathway (JM)

Health Science Career Field Allied Health and Nursing Pathway (JM) Health Science Career Field Allied Health and Nursing Pathway (JM) ODE Courses Possible Sinclair Courses CTAG Courses for approved programs Health Science and Technology 1 st course in the Career Field

More information

Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER

Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER LT Andrew Fine, Pharm.D., BCPS Safety Evaluator Division of Pharmacovigilance Office of Pharmacovigilance and Epidemiology

More information

EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST (Final 12/09/15)

EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST (Final 12/09/15) EXHIBIT 1 ACTIVELY RECRUITED POSITIONS LIST (Final 12/09/15) 340B Program Analyst 340B Program Manager Administrative Analyst V Administrative Director ADMINISTRATIVE DIRECTOR-DEPT OF RADIOLOGY Administrator

More information

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services LABORATORY TESTING SERVICES YOUR PARTNER IN LABORATORY MEDICINE The key note of progress in the 20th century is

More information

Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset

Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset Introduction In this era of strategic development deals, inventiv Health has significantly broadened

More information

Overview of Drug Development

Overview of Drug Development Overview of Drug Development Namrata Bahadur Head of Clinical Development & Medical Affairs Emerging Growth Markets 17 th 21 st March, Bangkok 2008 Novartis The information within this presentation is

More information

McKesson For Better Health

McKesson For Better Health McKesson For Better Health Better Health Starts with You Helping businesses and patients get healthier. Better Health Starts with You Changing lives. We are uniquely positioned to shape the future of Healthcare

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

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information

Safety Science Leader, LEAD

Safety Science Leader, LEAD Date: 07/06/16 Safety Science Leader, LEAD Job ID: 00448399 Job Function Drug Safety Location United States - California South San Francisco Company/Division Full-time Schedule Full-time Job type Regular

More information

To know more about Pharmacovigilance and Clinical Trials Data Management

To know more about Pharmacovigilance and Clinical Trials Data Management To know more about Pharmacovigilance and Clinical Trials Data Management 1. What is Pharmacovigilance? Pharmacovigilance (PV) is the pharmacological science related to the detection, assessment, understanding

More information