The following are past presentations, webinars, podcasts, and posters from various conferences, workshops, and seminars providing information from our subject matter experts.
 Feasibility Solutions to Clinical Trial NightmaresSue Robinson ICR Symposium - Finders Keepers: Novel Patient Recruitment & Retention Strategies November 2011 Why do similar audit findings continue to come up during subsequent audits?Nicky Dodsworth BARQA's The Bridge Between Regulation and Practice Echoes, Ethics and Electronic Documents November 2011 Clinical Evaluation of Medical Devices (German) Erdmann Zippel MEGRA’s Changes and new challenges of Medical Device Directive 2007/47/EU November 2011 GCP UpdateNicky Dodsworth and Janice Hedgecock (Greatspur Clinical Development Limited) ICR Ethics & GCP Forum November 2011 Managing FDA Inspections of Clinical TrialsGloria Miller, RAC CQA 2011 RAPS Annual Meeting October 2011 Safety Data Reconciliation for Serious Adverse Events (SAE)Joel Chamberlain, Diane Wagner, Gisele Buehler, Debaleena Bandopadhyay Oracle Health Sciences User Group 2011 Annual Meeting October 2011 Implementation and Benefits of Sort Order Functionality for Validation and Derivation ProceduresPhilip Parker and Sirisha Mareddy Oracle Health Sciences User Group 2011 Annual Meeting October 2011 Using the Aggregate Functionatliy when Programming Validation and Derivation ProceduresOliver Ho Oracle Health Sciences User Group 2011 Annual Meeting October 2011 Motivating and Training the Investigators & Site StaffMirela Teodoreci
EICCRP's Partnering for Success in Clinical Trials October 2011 Case Study: Two Arm, Double Randomized Post-market StudySunita Ahir, Ph.D.
Q1 Production's 4th Annual European Medical Device Clinical Research Conference October 2011 Bridging the Research GAP: QA’s Solution to Building Quality ConnectionsNicky Dodsworth and Sherri Hubby
2011 BARQA Annual Meeting September 2011 How to Perform a Medical Device Clinical TrialErdmann Zippel
BARQA Seminar: Clinical Evidence to Support the Development of Medical Devices July 2011 The Process of Updating Design Risk Analysis based on Clinical Data Output and ComplaintsPatricia Aherne
BARQA Seminar: Clinical Evidence to Support the Development of Medical Devices July 2011
The Need for Clinical Investigation and the Significance of Risk Analysis for Medical Devices Sunita Ahir, Ph.D.
from 47th DIA Annual Meeting June 2011
Effective Pediatric Assent Forms: Overcoming Common Obstacles SessionElizabeth Jay, RN, MA
from ACRP 2011 Global Conference & Exhibition May 2011 Global Paediatric Studies–a CRO PerspectiveSusan Bhatti, Ph.D.
from IQPC's Integrated Paediatric Drug Development Congress April 2011 A Comparative Review of Inspection Techniques and Regulatory Considerations between the EMA, MHRA and FDA in Clinical TrialsSherri Hubby and Nicky Dodsworth
from 23rd Annual EuroDIA Meeting March 2011 Case Study: Global Regulatory Pathways for Registration of a Combination ProductBernard Sweeney
from 23rd Annual EuroDIA Meeting March 2011 Looking at the Outomes of a Clinical Trial Conducted OUS: A Case StudySunita Ahir, Ph.D.
from 5th Annual Medical Device Clinical Research & Reimbursement Conference March 2011 EU Initiatives for Simplifying Clinical Trial Approval
Concerns and Initiatives: An OverviewSusan Bhatti, Ph.D. from EFGCP Workshop on Streamlining Applications to the Regulatory & Ethical Review Processes March 2011 Guidance for Auditing Quality Systems of IECs in EuropeNicky Dodsworth from EFGCP Workshop on Complex Cases for Research Ethics Committees February 2011  GCP Updates, News and InformationNicky Dodsworth from ICR’s Ethics & GCP Forum October 2010
Highlight of Oracle Clinical Functionality for Validation Edit ChecksJulie Lavoie from Oracle Health Sciences User Group 15th Annual Conference October 2010 Developing and Implementing an Edit Check Testing Training ProgramOliver Ho from Oracle Health Sciences User Group 15th Annual Conference October 2010 How to Load a Data File in Oracle ClinicalTejas Patel, Cheryl Silva from Oracle Health Sciences User Group 15th Annual Conference October 2010 Implementing a Successful Corrective and Preventative Action ProgramSherri Hubby from DIA Good Clinical Practices and Quality Assurance SIAC Webinar September 2010 Meeting Enrollment Goals in a Competitive Environment:
Development, Implementation and Monitoring of Site Patient Recruitment and Enrollment PlansJacqueline M. Zarro, PhD from 46th DIA Annual Meeting June 2010 Maximizing Efficiencies in Project Management and Monitoring through a Centralized Resourcing ModelCindi Stout from 46th DIA Annual Meeting June 2010 Key Considerations for Conducting a Pediatric Research StudyKathryn Bohannon, Susan Franks, MS, and Susan Bhatti, PhD from 46th DIA Annual Meeting June 2010 Practical Considerations for Leading Effective Global Drug Development Teams and Helpful Technology TipsSeven Lueder-Powers and Angi Robinson from 46th DIA Annual Meeting June 2010 A Medical Writing Essential: Reviewing Statistical Analysis PlansAnita Frijhoff, PhD, ELS from 46th DIA Annual Meeting June 2010 Investigational New Drug (IND) Applications: A Case Study of Document Development from the Medical Writing Perspective
Marilyn Ingram from 46th DIA Annual Meeting June 2010 Outsourcing Paediatric Investigation PlansSusan Bhatti, Ph.D. from IQPC's Integrated Pediatric Drug Development June 2010
Pediatric Assent: Key Factors for Forms and ProceduresElizabeth Jay, RN MA and Kathryn Bohannon, BA from ACRP 2010 Conference April 2010
IT Infrastructure Qualification Planning
Carolyn Stockdale
from IQPC's IT Infrastructure Compliance, Security and Risk Management Conference
November 2009
Impact of Evolutions in Medical Device Directives on Clinical Trial Requirements
Sunita Ahir, Ph.D.
from Q1 Productions Medical Devices Clinical Research Conference
November 2009Podcast Interview: Current Challenges for Device Companies Conducting Clinical Trials in Europe
Efraim Roe Kozorovitsky
from Q1 Productions Blog
October 2009
Performing Patient Position Removal with Existing Production Data: When, Why and How
Eugene Sidharto and Scott Tomestic from the Oracle Clinical Users Group 14th Annual Conference October 2009 Pulling Metric Reports for Post-Data Entry Mass Updates
Scott Tomestic from the Oracle Clinical Users Group 14th Annual Conference October 2009 Effective Validation of Edit Checks through Efficient Test Data
Oliver Ho from the Oracle Clinical Users Group 14th Annual Conference October 2009 Organizing Training for Oracle RDC Onsite
Cheryl Silva and Oliver Ho from the Oracle Clinical Users Group 14th Annual Conference October 2009 The Role of Routine Enhanced Audits
Nicky Dodsworth
from International DGGF Meeting 2009
September 2009 Clinical and Regulatory Master Plan
Sunita Ahir, Ph.D. and Efraim Roe Kozorovitsky
from FX Medical Device Conferences
September 2009
Parental Permission and Patient Assent in Pediatric Trials:
Key Considerations for Forms and ProceduresElizabeth Jay, RN MA, Joy Drew, RN BSN, and Kathryn Bohannon, BA from 45th DIA Annual Meeting June 2009 Managing High Performance Project Teams
Jacqueline Zarro, Ph.D. from 45th DIA Annual Meeting June 2009 Facilitating Communications within a Global Project Team:
Practical TipsJacqueline Zarro, Ph.D. from 45th DIA Annual Meeting June 2009 Medical Writing and the Parallel Processing Approach™Anita Frijhoff, Ph.D., ELS from 45th DIA Annual Meeting June 2009 Integration of Q9 Quality Risk Management When Conducting GCP Regulatory Inspections and AuditsSherri Hubby from 45th DIA Annual Meeting June 2009 Best Practices for Implementation and Analysis of Pain Scale Patient Reported Outcomes in Clinical TrialsNan Shao, Ph.D. and Mark Jaros, Ph.D. from 30th Annual Society for Clinical Trials Meeting May 2009 What comes after the Medical Devices Directive?:
Global Harmonisation of the Clinical Evaluation of Medical DevicesSunita Ahir, Ph.D. from Medical Devices Clinical Congress April 2009 Use of IVRS in the Collection of Primary Endpoints and Assessment of Patient Diary Entry ComplianceBruce Bailey from CHI's Electronic Data in Clinical Trials March 2009 Keith Fine from 24th Annual DIA Data Conference March 2009 International Clinical Trials: A Regulatory PerspectiveJames Ottinger, RPh American Society for Experimental NeuroTherapeutics (ASENT) Annual Meeting March 2009 Oracle Clinical Consolidation Across the Channel and the Ocean - Experiences in a Global CRODirk Markwardt from Oracle Pharma Day 2009 February 2009 Medical Device Research and Regulations in IsraelEfraim Roe Kozorovitsky from FX Medical Device Conferences February 2009 The Role of Routine Enhanced AuditsNicky Dodsworth from EFGCP Annual Conference 2009 January 2009
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