Perspectives on Patient Recruitment

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Perspectives on Patient Recruitment"

Transcription

1 Webcast Perspectives on Patient Recruitment Sponsors:

2 Presenters Moderator: Christiane Truelove Editor in Chief, R&D Directions Speakers: Dr. Bradley Vince, D.O., President and Medical Director, Vince and Associates Clinical Research Jeffrey M. Zucker Senior Director and Global Head, Patient Recruitment, Kendle Kathy Chase, Pharm.D. IRB chair, MidLands IRB; Director, Provider Services, Cardinal Health Pharmacy Solutions

3 Bradley Vince, D.O. President and Medical Director 3

4 Dr. Vince has participated in over 325 clinical trials His focus is Phase 1 to Proof of Concept Dr. Vince was involved in the design and construction of their new 90 bed Early Development Unit. The objective of this new facility is enhanced recruitment of patient population trials and studies with long-term confinement periods. 4

5 5

6 Discussion Topics: Overview Finalizing the Protocol Feasibility Recruitment Medical Oversight Retention 6

7 Special populations are being enrolled earlier in the clinical trials process More Phase I trials (including FIH and MAD) are: Incorporating patient populations into the study design Often consolidating SAD/MAD/POC studies into one protocol with an adaptive design This depends on: Safety profile of the compound Therapeutic area This approach conserves development time and provides an earlier read on potential efficacy and tolerability 7

8 Early Physician Feedback Critical Ensures that: Safety measures are acceptable Execution is realistic Study populations are recruitable Quick Turn Around (1 week) from the PI or Medical Director Should be provided as a no-cost service to clients 8

9 Feasibility Assessments Speed important, but accurate feedback is more important In-depth feasibility protects against expensive rescue efforts PI involvement necessary to validate protocol feasibility at the site Additional review from clinical operations, regulatory, recruitment, lab and others minimize costly mistakes prior to study start Verify accuracy of the metrics from the site Unfortunately, sites often over-commit Always have Plan B 9

10 Considerations for Special Population Feasibility Assessments Competing trials (not just at the site but in the region) Competition from marketed drugs Subject compensation Time of year Risk Benefit Ratio Likelihood of placebo 10

11 Special Population Volunteers HNV Recruitment is more challenging Compensation is not always the priority Confinement periods are more problematic Evening call center hours are imperative Scheduling flexibility (including evenings and weekends) Usually not professional volunteers 11

12 Accountability Who is accountable at site level? Database Verify it Bigger is not always better Advertising Understand the site s plan Advertising dollars should be specific to YOUR study (not generic) If additional advertising funds are needed funds recruitment Market saturation Competing trials Skin in the game 12

13 Competition is good (multi-center studies) s, Newsletters FSFV Milestone, Most Randomized Call the PI Confirm Appointments Welcome packets and handholding Physician Referrals Beware 13

14 Special population volunteers HNV Existing medical co-morbidities Require additional medical oversight Concomitant medications AE assessment 14

15 Special population volunteers HNV More family involvement Require more personal attention of P.I. Have more medical questions 15

16 Staff (Warm and Empathetic) Meals (Hot and Tasty) Lighting (Bright with Natural Light) Dorm Size and Assignments (Room to Roam) Mattresses (Sounds Trivial) Technology (70 s, 80 s or today?) Entertainment (Wifi, Movies, How many TVs?, Activities) 16

17 Customer Service Training (Serve, Serve, Serve) Full-time Housekeeper (White-glove inspection) Bathrooms (Individual and private) Medical Safety (Highly visible nurses station) Physician Availability (That s my P.I.) Access Outdoors (Sunshine) Visitors (Welcome; but have a plan and process) Compensation (Important, but only part of the answer) 17

18 Beyond Paper Using data-driven expertise to enhance patient recruitment Jeffrey Zucker, MS Senior Director and Global Head, Patient Recruitment Kendle

19 Agenda Components to successful recruitment planning Role of Feasibility Use of internal resources Accessing external data Applying the data to simulate recruitment timelines Factoring in recruitment tactics Optimizing timelines Measuring success 19 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

20 Components Vendors Internal Expertise Feasibility Regulatory Patient Recruitment Medical Affairs Marketing Investigator Consult Key Opinion Leaders 20 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

21 Pillars of feasibility Feasibility Internal data External data Medical review and engagement Previous trials conducted database/ctms Previous experience with investigators Regulatory and contract timelines Expertise of internal staff and lesson s learned Standard of care for indication and country Competing clinical trials Disease incidence/prevalence Benchmarking/clinical trial intelligence Detailed examination of protocol medical team Identify and engage key opinion leaders as needed Develop relationships with key advocacy/support groups Internal expertise and relationships Site-specific questionnaires Validate assumptions Confirm investigator availability and build interest in trial Explore potential patient recruitment strategies 21 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

22 Internal resource Medical Medical Affairs Full review of I/E criteria Identify barriers and opportunities Study design review Burden on subject and site Compare to standard of care Comparison to past trials Identify site requirements Specialty Geography Patient access 22 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

23 Internal resource Marketing Marketing Evaluate current therapeutic market globally Opportunities for emerging markets Identify key physicians Can influence other investigators Access to prescription data Identify hot spots for med use Competitive information Pipeline information on other companies 23 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

24 Internal resource Regulatory Regulatory Regulatory timelines are often underestimated Need full review of protocol to evaluate for country requirements Various tactics are not allowed in certain countries but some are just not typically used 24 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

25 External resource KOLs and Investigator consult Key Opinion Leaders Investigator Consult Clinical protocol guidance Standard of care Medical trends Operational guidance Recruitment issues Competitive landscape 25 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

26 External resource Vendors Vendors Media buying Material development Recruitment planning Database driven outreach Prescription data Chart reviewing at sites Recruitment workshops Website design and maintenance Site selection Text messaging New services emerging daily 26 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

27 Recruitment simulation Using data to predict success

28 Timeline modeling 250 patients were enrolled in 16 months or less 50% of the time 28 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

29 Recruitment curve 250 patients were enrolled in 16 months or less 50% of the time 29 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

30 Optimizing probability of success Change country mix Different distribution of patient allocation Over allocate patients/sites Back up sites/countries Entering additional recruitment tactics Propose protocol changes Re-run the model with new assumptions 30 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

31 Measure performance During the trial, clear milestones and contingencies need to be Every program needs and after action review Identify success, failure, barriers, and opportunities Make it an official document that is engrained into the process Conduct a team meeting to review results 31 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

32 Summary Be sure to use all internal and external resources All data is helpful just be sure you know the validity and reliability Use data to support your decisions around study planning Modeling recruitment using the data is helpful to generate discussion Specific and measureable recruitment tactics Work into the model and re-run simulation Learn from experience Minimize repetition of mistakes Leverage knowledge to identify opportunities Use common sense when analyzing data and results 32 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a

33 IRB Considerations in Proof of Concept Trials Kathy Chase, Pharm.D. Chair, MLIRB

34 Proof of Concept Research Study Proof of principle / concept study First time in humans Target disease state

35 Basic Elements of IRB Review Protocol Informed consent form Recruiting materials Safety reports Ongoing results

36 Fundamental Responsibility of IRB Assure the rights &welfare of the subject is protected IRB membership Review process Initial review Ongoing review

37 IRB Evaluation Drug Product Experience Animal studies In vivo studies Human studies Data source

38 IRB Evaluation Research Protocol Objectives/Purpose Study Design Risk vs benefit Healthy vs disease Subject Selection Inclusion criteria Exclusion criteria

39 IRB Evaluation Research Protocol Study Methods/Procedures/Plan Diagnostic testing Dose escalation Adverse Events/Deviations Definitions Prescriptive action Evaluation Methods/Statistical Analysis

40 IRB Evaluation Informed Consent Form

41 IRB Evaluation Informed Consent Form Readability Eighth grade reading level Format

42 IRB Evaluation Informed Consent Form Purpose Easy to read The purpose of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. First time in Humans

43 IRB Evaluation Informed Consent Form Description of procedures Schedule of tests and drug administration Diagnostic tests Blood draws Frequency Amount Diaries

44 IRB Evaluation Informed Consent Form Risks Animal studies In vivo studies Human studies Similar agents

45 IRB Evaluation Informed Consent Form Risks Pregnancy risks Women Men Diagnostic test risks Psychological risks

46 IRB Evaluation Informed Consent Form Benefits Alternative Therapy

47 IRB Evaluation Subject Recruitment Vulnerable populations Children Prisoners Chronic disease Inducement IRB oversight

48 Ongoing IRB Actions Safety analysis Protocol deviations Progress reports

49 IRB Evaluation Safety Reports Serious adverse events Report to IRB IRB actions Informed consent modifications Protocol modifications FDA report Subject follow up

50 IRB Evaluation Protocol Deviations IRB review Description of deviation Intended deviation Unintended deviation IRB responsibility

51 IRB Evaluation Progress Report Frequency of Review IRB Analysis Safety Protocol deviations Audit results

52 Questions Webcast Q&A Thank you for joining us today for our webcast on Perspectives on Patient Recruitment! If you have any other questions, feel free to contact us at: Bradley Vince, D.O. President and Medical Director Rimmy Junday Account Manager Langland Quadrant Kathy Chase, Pharm.D. Chair MLIRB

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure

More information

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com volunteering for a clinical trial www.centerwatch.com :: about this pamphlet This pamphlet provides an overview of the clinical trials process and answers frequently asked questions that many potential

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Investigational Drugs: Investigational Drugs and Biologics

Investigational 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 information

Reporting of Adverse Events and Unanticipated Problems

Reporting of Adverse Events and Unanticipated Problems Reporting of Adverse Events and Unanticipated Problems Policy date: 12/2011 Purpose The purpose of this policy is to ensure that the review, reporting and analysis of adverse events and unanticipated problems

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon 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 information

Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute

Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute Understand the protocol completely Recognize institutional polices

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

Protecting Phase I Subjects IRB Considerations for Phase I Review of Research June 5, 2013

Protecting Phase I Subjects IRB Considerations for Phase I Review of Research June 5, 2013 Webinar Series Protecting Phase I Subjects IRB Considerations for Phase I Review of Research June 5, 2013 Presented by: Julie Blasingim Director of Operations, Clinical Pharmacology About Schulman Associates

More information

Patience In Patient Recruitment

Patience In Patient Recruitment Patience In Patient Recruitment Examining Current Challenges with Humans in Phase I Clinical Trials Bryan McIntyre, Senior Vice President - Inclinix, Inc. Richard Anthony Ph D, CEO Catalyst Pharma, Inc.

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

How to Run Clinical Trials in Private Practice

How to Run Clinical Trials in Private Practice How to Run Clinical Trials in Private Practice Thomas M. Siler, MD Midwest Chest Consultants, PC Saint Charles, MO DISCLOSURE Dr. Siler has received research grants from GlaxoSmithKline, Forest, Boehringer

More information

Clinical Trials Glossary

Clinical Trials Glossary Clinical Trials Glossary ADME: an acronym for absorption, distribution, metabolism and elimination. ADME studies determine how a drug is absorbed by the body, the chemical changes that it may undergo and

More information

Good Clinical Practice Compliance and the Start-up Company

Good Clinical Practice Compliance and the Start-up Company Good Clinical Practice Compliance and the Start-up Company By Robert Schiff, PhD, RAC, CQA, FRAPS, Jodi Pannucci and Mary Ann Weinberg 26 Start-up drug or device companies tend to minimize spending and

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

Transforming study start-up for optimal results

Transforming study start-up for optimal results Insight brief Transforming study start-up for optimal results A holistic, data-driven approach integrating technology, insights and proven processes to position clinical trials for ultimate success Up

More information

IRB Review of Recruitment Materials Engaging Subjects Responsibly & Ethically December 10, 2014

IRB Review of Recruitment Materials Engaging Subjects Responsibly & Ethically December 10, 2014 Webinar Series IRB Review of Recruitment Materials Engaging Subjects Responsibly & Ethically December 10, 2014 Presented by: Kim Looney and Ashley Dixon IRB Members, Schulman Associates IRB About Schulman

More information

This policy applies to all clinical research conducted at Beaumont Health System.

This policy applies to all clinical research conducted at Beaumont Health System. CLINICAL RESEARCH QUALITY AND PROCESS IMPROVEMENT PROGRAM 113 1 of 6 PURPOSE Prior The purpose of this policy is to provide an overview of the Clinical Research Quality and Process Improvement Program

More information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up

More information

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research FDA Audit Guidelines University of Miami Office of the Vice Provost for Research FDA Audit Guidelines Contents INTRODUCTION 3 VICE PROVOST FOR RESEARCH ROLE IN FDA AUDITS 3 PRE-AUDIT REVIEW 3 INSPECTION

More information

The Beginner Research Assistant/Coordinator (CRC) Track Basic Level

The Beginner Research Assistant/Coordinator (CRC) Track Basic Level The Beginner Research Assistant/Coordinator (CRC) Track Basic Level Who: Clinical Research Assistant (CRA) CRC I This track was designed for the CRA/CRC I with less than 2 years of clinical research experience.

More information

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS Objectives

More information

2014 Metrics on Human Research Protection Program Performance

2014 Metrics on Human Research Protection Program Performance 2014 Metrics on Human Research Protection Program Performance Updated May 15, 2015 About the Metrics Improving the quality of human research protection programs (HRPP) is a top priority of AAHRPP. Effective

More information

Role 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 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 information

Effective Strategies for Patient Recruitment and Retention. Do You Have Your Calculators Ready?

Effective Strategies for Patient Recruitment and Retention. Do You Have Your Calculators Ready? Effective Strategies for Patient Beth Harper, BS, MBA President, Clinical Performance Partners, Inc. Do You Have Your Calculators Ready? 2 CRC Best Practices 3.0 1 3 What do calculations have to do with

More information

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV)

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell,

More information

University 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 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 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

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind

Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind Carol Breland, MPH, RRT, RCP NC TraCS Research Recruitment Director Learning

More information

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Not All Clinical Trials Are Created Equal Understanding the Different Phases Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact

More information

Roles & Responsibilities of the Research Team

Roles & Responsibilities of the Research Team Roles & Responsibilities of the Research Team Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Introduction All staff involved in clinical

More information

December 13, 2011 Maureen Coyne

December 13, 2011 Maureen Coyne December 13, 2011 Maureen Coyne No industry relationships No financial conflicts of interests Recent experience weighted toward industrysponsored clinical trials Information based on my experiences IRB

More information

UC DAVIS OFFICE OF RESEARCH AAHRPP Preparation UC Davis Human Research Part IV Criteria for Review. Cindy Gates IRB Administration

UC DAVIS OFFICE OF RESEARCH AAHRPP Preparation UC Davis Human Research Part IV Criteria for Review. Cindy Gates IRB Administration UC DAVIS OFFICE OF RESEARCH AAHRPP Preparation UC Davis Human Research Part IV Criteria for Review Cindy Gates IRB Administration Tips for Reviewer s Comments - Comments should be easily transferrable

More information

Yale Cancer Center Data and Safety Monitoring Committee Charter

Yale Cancer Center Data and Safety Monitoring Committee Charter Yale Cancer Center Data and Safety Monitoring Committee Charter Purpose/Mission The purpose of the Yale Cancer Center (YCC) Data and Safety Monitoring Committee (DSMC) is to provide ongoing data and safety

More information

Operational aspects of a clinical trial

Operational aspects of a clinical trial Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration

More information

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N.

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. NEGOTIATING CLINICAL TRIAL BUDGETS Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. A.B.N. Amateur Budget Negotiator OVERVIEW Budget Types Analyzing the Protocol Negotiating the Contract Discussion / Tips

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

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

Template for essential information to be provided for proposals including clinical trials / studies / investigations

Template for essential information to be provided for proposals including clinical trials / studies / investigations Template for essential information to be provided for proposals including clinical trials / studies / investigations Document history Version 2016callsV1 September 2015 Modifications (compared to previous

More information

Research Study Protocol Template

Research Study Protocol Template Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator

More information

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP. Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection

More information

Quality Management in Clinical Research

Quality Management in Clinical Research Quality Management in Clinical Research Julie Doherty MSN, RN Director, Regulatory Compliance Office of Academic Affairs Human Research Protections Office University of Maryland Baltimore March 17, 2016

More information

EMR Systems and the Conduct of Clinical Research. Daniel E Ford, MD, MPH Vice Dean for Clinical Investigation Johns Hopkins School of Medicine

EMR Systems and the Conduct of Clinical Research. Daniel E Ford, MD, MPH Vice Dean for Clinical Investigation Johns Hopkins School of Medicine EMR Systems and the Conduct of Clinical Research Daniel E Ford, MD, MPH Vice Dean for Clinical Investigation Johns Hopkins School of Medicine Clinical Research Environment Research protocols are becoming

More information

Friday, May 2. Clinical Trials: Is Your Staff Competent? Session 10:15 11:45 am Ballroom C

Friday, May 2. Clinical Trials: Is Your Staff Competent? Session 10:15 11:45 am Ballroom C Session 10:15 11:45 am Ballroom C Clinical Trials: Is Your Staff Competent? What fundamental skills and knowledge should clinical trials nurses have? In response to questions from its members about how

More information

Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective

Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective Office of Vaccines Research and Review Center for Biologics Evaluation and Research U.S. Food

More information

No. 706. Page 1 of 5. Issue Date 4/21/2014

No. 706. Page 1 of 5. Issue Date 4/21/2014 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page

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

U.S. Food and Drug Administration

U.S. Food and Drug Administration U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained

More information

Clinical Trials: The Crux of Cancer Innovation

Clinical Trials: The Crux of Cancer Innovation Clinical Trials: The Crux of Cancer Innovation Even as medical science is transforming cancer care, major deficiencies in the way cancer clinical trials are designed, carried out, regulated and funded

More information

Josephine Silvestre, RN, MSN The University of Chicago Medical Center. October 13, 2007

Josephine Silvestre, RN, MSN The University of Chicago Medical Center. October 13, 2007 Josephine Silvestre, RN, MSN The University of Chicago Medical Center October 13, 2007 A study in which people participate as volunteers. A clinical trial is conducted to develop potential new treatments

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

Strategic Consulting Services

Strategic Consulting Services Services 1 Leadership Team Mark Levonyak President mlevonyak@davaonc.com Mobile: 214.460.5051 Martin W. Lee, MD EVP, Clinical Trial Services mlee@davaonc.com Mobile: 952.373.1405 John Eckardt, MD Chief

More information

12.0 Investigator Responsibilities

12.0 Investigator Responsibilities v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by

More information

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name

More information

Study Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting

Study Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting M-306.00 SOP for Adverse Event Reporting Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature

More information

Health Sciences Network Real-time Access To Healthcare Data for R&D Through Post Market Research

Health Sciences Network Real-time Access To Healthcare Data for R&D Through Post Market Research Health Sciences Network Real-time Access To Healthcare Data for R&D Through Post Market Research Joel Haspel Director Health Sciences 21, October, 2014 Safe Harbor statement The following is intended to

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

Points to Consider When Developing a TMF (Trial Master File) Strategy

Points to Consider When Developing a TMF (Trial Master File) Strategy PHLEXGLOBAL WHITE PAPER Points to Consider When Developing a TMF (Trial Master File) Strategy Presented By: Karen Redding Global Business Development Director Phlexglobal Ltd. kredding@phlexglobal.com

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

Guidance for Industry

Guidance for Industry Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE 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 information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities

More information

Clinical trials in haemophilia

Clinical trials in haemophilia Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical

More information

To Certify or Not to Certify

To Certify or Not to Certify To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus November

More information

To Certify or Not to Certify Sandra Halvorson, BA, CCRP

To Certify or Not to Certify Sandra Halvorson, BA, CCRP To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II We have no financial relationships

More information

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:

More information

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

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 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 information

Section 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 Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership PROJECT MANAGEMENT - SCOPE DEFINITION AND MANAGEMENT Understands the

More information

PREP Course #17: Are we there yet? Achieving Enrollment Success

PREP Course #17: Are we there yet? Achieving Enrollment Success PREP Course #17: Are we there yet? Achieving Enrollment Success Cerdi Beltre, CIP, CCRP Administrative Director, Clinical Research Service Director, Clinical Research Operations, NSLIJ 516-562-0340, cbeltre@nshs.edu

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

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans NOTE: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. DAIDS has clearly stated the minimum requirements for the CQMP and provided examples

More information

Formulary Management

Formulary Management Formulary Management Formulary management is an integrated patient care process which enables physicians, pharmacists and other health care professionals to work together to promote clinically sound, cost-effective

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

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

Pre-Questions. Mastering Clinical Research July 29, 2015

Pre-Questions. Mastering Clinical Research July 29, 2015 Pre-Questions Mastering Clinical Research July 29, 2015 1. To be compliant with SOP 2.1 Obtaining Informed Consent for greater than minimal risk interventional clinical trial, which Licensed Professional

More information

Elaborate on how to assess reasonable risk and dose selection based on preclinical data

Elaborate on how to assess reasonable risk and dose selection based on preclinical data May 7, 2014 Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2013-D-0576, Draft Guidance for Industry: Considerations

More information

ICH CRA Certification Guide March 2009

ICH CRA Certification Guide March 2009 ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS

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

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18 th WMA General Assembly Helsinki, Finland, June 1964 and amended by

More information

Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring

Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring Brett Barber, Sr. Director, Strategic Resourcing Nicole Baker, Sr. Director, Strategic

More information

Core Training Outline

Core Training Outline Core Training Outline Modules: 1) Study Design 2) PI Oversight 3) Financial Management 4) Study Operations 5) Recruitment & Retention 6) Informed Consent 7) Investigational Products 8) Subject Safety 9)

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

LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office

LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1033 LU Process for Assessing Site Feasibility for NHS Research Sponsored by Loughborough

More information

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis The Monitoring Visit Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis Disclosure The information herein is not intended to

More information

Other responsibilities- Participated in contract development and oversight for out-sourced pharmacy services

Other responsibilities- Participated in contract development and oversight for out-sourced pharmacy services Karen Vitacolonna Falk, RPh, MBA 17 John Alexander Drive Cortlandt Manor, NY, 10567 (914) 739-1462 (home), 212-305-7607 (work) email -Karen@cstat.com, kvitacol@nyp.org EXPERIENCE: COMSTAT RESEARCH CORP.

More information

Electronic Medical Records and Source Data for Research: What s the Difference?

Electronic Medical Records and Source Data for Research: What s the Difference? Electronic Medical Records and Source Data for Research: What s the Difference? Tammy Anderson, CCRC, CCRA, CRCP Director, Clinical Trials Office Virginia Commonwealth University Research Coordinator 4

More information

Practical aspects of early phase oncology trials the oncologists view

Practical aspects of early phase oncology trials the oncologists view Practical aspects of early phase oncology trials the oncologists view S. E. Al-Batran, MD Head, Institute of Clinical Cancer Research (IKF) University Cancer Center (UCT) Nordwest Hospital Frankfurt Outline

More information

Site Level Feasibility Assessment Guidance

Site Level Feasibility Assessment Guidance Site Level Feasibility Assessment Guidance What is a feasibility assessment? Feasibility is a process of comprehensive analysis and planning, including risk assessment and contingency planning. Aims of

More information

INTRODUCTION TO CLINICAL TRIAL. Dr.K.T. Manisenthil Kumar, Head, Department of pharmacology, KMCH college of pharmacy, Coimbatore, Tamilnadu, India.

INTRODUCTION TO CLINICAL TRIAL. Dr.K.T. Manisenthil Kumar, Head, Department of pharmacology, KMCH college of pharmacy, Coimbatore, Tamilnadu, India. INTRODUCTION TO CLINICAL TRIAL Dr.K.T. Manisenthil Kumar, Head, Department of pharmacology, KMCH college of pharmacy, Coimbatore, Tamilnadu, India. INTRODUCTION The safety and toxicity data generated from

More information

How to Design a Clinical Trial. Harvey Lui, MD, FRCPC

How to Design a Clinical Trial. Harvey Lui, MD, FRCPC How to Design a Clinical Trial Harvey Lui, MD, FRCPC Outline Why do clinical trials? How to review a study protocol How to design a study protocol Why do a clinical trial? Why do a clinicaltrial? To answer

More information

Clinical Research Professional Certification & Preparing for the CCRP Exam

Clinical Research Professional Certification & Preparing for the CCRP Exam Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP SoCRA: Society of Clinical Research Associates SoCRA established the Certification Program

More information

Cancer Clinical Trials: The Basics

Cancer Clinical Trials: The Basics Cancer Clinical Trials: The Basics What Are Cancer Clinical Trials? Research studies involving people Try to answer scientific questions and find better ways to prevent, diagnose, or treat cancer 2 Why

More information

EHR4CR ENABLING PROACTIVE RESEARCH

EHR4CR ENABLING PROACTIVE RESEARCH EHR4CR ENABLING PROACTIVE RESEARCH Neelam Patel Neelam Consulting Electronic Health Records for Clinical Research 76 Why change how I currently operate? To more visible to the clinical trial community

More information

Emerging Early Clinical Research Capabilities in Asia-Pacific. Dr. Chew Lan CHONG Executive Director, Medical Research Feb 2015

Emerging Early Clinical Research Capabilities in Asia-Pacific. Dr. Chew Lan CHONG Executive Director, Medical Research Feb 2015 Emerging Early Clinical Research Capabilities in Asia-Pacific Dr. Chew Lan CHONG Executive Director, Medical Research Feb 2015 Questions What is driving the interest in performing early clinical research

More information

William B. Smith, MD President. Patrick R. Ayd, RN, MBA Chief Operating Officer. SNBL-CPC Baltimore, Maryland

William B. Smith, MD President. Patrick R. Ayd, RN, MBA Chief Operating Officer. SNBL-CPC Baltimore, Maryland Patrick R. Ayd, RN, MBA Chief Operating Officer SNBL-CPC Baltimore, Maryland William B. Smith, MD President New Orleans Center for Clinical Research / Volunteer Research Group University of Tennessee Medical

More information

PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS

PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS If you have ever taken a medication or received rehabilitative physical therapy, then you have experienced the benefits of clinical research.

More information