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NEW! A Systematic Approach to Study Start-Up: Improving Site Activation - October 18, 2019

Course #: BI13764
October 18, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance - October 21, 2019

Course #: BI13649
October 21, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective - October 21, 2019

Course #: BI13650
October 21, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for Industry - October 22, 2019

Course #: BI13651
October 22, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry - October 23, 2019

Course #: BI13655
October 23, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Data Quality in Clinical Trials: Rationale and Impact - October 23, 2019

Course #: BI13656
October 23, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Risk-Based Auditing: Effective Compliance Strategies - October 23, 2019

Course #: BI13657
October 23, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Use of Notes to File in Clinical Trial Essential Documentation - October 24, 2019

Course #: BI13659
October 24, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$751.50

Negotiation Skills for Clinical Research Professionals - October 24, 2019

Course #: BI13658
October 24, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately - October 24, 2019

Course #: BI13660
October 24, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$562.50

10-Week Clinical Research Associate (CRA) On-Boarding Program - October 25, 2019 - January 17, 2020

Course #: BI13570
October 25, 2019 - January 17, 2020 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class November 29, December 27, January 3.

Resume support is available as an add-on option! Click here for more details.

$1,795.50

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs - October 25, 2019

Course #: BI13662
October 25, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program - October 25, 2019 - January 17, 2020

Course #: BI13573
October 25, 2019 - January 17, 2020 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Friday Afternoons. No class November 29, December 27, January 3.

Resume support is available as an add-on option! Click here for more details.

$1,795.50

FDA Drug Approval Process - October 28, 2019

Course #: BI13691
October 28, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$661.50

NEW! Clinical Research Financial Management for Investigative Sites - October 28, 2019

Course #: BI13665
October 28, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Protocol Deviations: Documenting, Managing, and Reporting - October 28, 2019

Course #: BI13664
October 28, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Introduction to Clinical Research - October 29, 2019

Course #: BI13666
October 29, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

FDA Medical Device Approval Process - October 29, 2019

Course #: BI13667
October 29, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management - October 30, 2019

Course #: BI13668
October 30, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

CRA Current Practice Update: Impact of the FDA Bioresearch Monitoring (BIMO) Program - October 30, 2019

Course #: BI13669
October 30, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Investigational Product Accountability Best Practices - October 31, 2019

Course #: BI13670
October 31, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Trial Master Files: Why They Are Important and How to Organize Them Workshop - November 01, 2019

Course #: BI13671
November 1, 2019 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites - November 04, 2019

Course #: BI13631
November 4, 2019 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

10-Week CRA & CRC Beginner Program - November 04, 2019 - January 20, 2020

Course #: BI13568
November 4, 2019 - January 20, 2020 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class December 23, December 30.

Resume support is available as an add-on option! Click here for more details.

$1,795.50

Informed Consent Procedure: Lessons Learned from Inspection Findings - November 04, 2019

Course #: BI13672
November 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Strategies for Having Difficult Conversations - November 05, 2019

Course #: BI13674
November 5, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Current FDA and EMA Inspection Findings: Lessons Learned - November 05, 2019

Course #: BI13673
November 5, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Strategies for Active Listening - November 05, 2019

Course #: BI13708
November 5, 2019 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$661.50

Data Management Plan Creation: Content and Rationale - November 06, 2019

Course #: BI13675
November 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Leading Teams in a Changing Clinical Research Environment - November 06, 2019

Course #: BI13676
November 6, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research - November 07, 2019 - January 30, 2020

Course #: BI13577
November 7, 2019 - January 30, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons. No class November 28, December 26, January 2.

Resume support is available as an add-on option! Click here for more details.

$1,795.50

The GCPs of Essential Documents - November 07, 2019

Course #: BI13677
November 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program - November 08, 2019 - January 31, 2020

Course #: BI13586
November 8, 2019 - January 31, 2020 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Friday Mornings. No class November 29, December 27, January 3.

Resume support is available as an add-on option! Click here for more details.

$1,795.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance - November 08, 2019

Course #: BI13678
November 8, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

Sponsor Management of Investigator Non-Compliance - November 11, 2019

Course #: BI13679
November 11, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Case Report Form Design, Strategy, and Standards Workshop - November 12, 2019

Course #:  BI13680 
November 12, 2019 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

CAP and CLIA Requirements for Clinical Research Laboratories - November 12, 2019

Course #: BI13681
November 12, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Medical Writing Fundamentals: How to Write Regulatory Documents - November 13, 2019

Course #: BI13682
November 13, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Regulatory Intelligence - November 13, 2019

Course #: BI13683
November 13, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

NEW! Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles - November 14, 2019

Course #: BI13684
November 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts - November 14, 2019

Course #: BI13685
November 14, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

NEW! Implementing Quality Agreements - November 15, 2019

Course #: BI13686
November 15, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

NEW! Establishing Quality Tolerance Limits - November 15, 2019

Course #: BI13687
November 15, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance - November 18, 2019

Course #: BI13688
November 18, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

Introduction to Statistics for Non-Statisticians - November 18, 2019

Course #: BI13689
November 18, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155 - November 19, 2019

Course #: BI13690
November 19, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual - November 19, 2019

Course #: BI13692
November 19, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring - November 19, 2019

Course #: BI13693
November 19, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies - November 19, 2019

Course #: BI13694
November 19, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$751.50

10-Week Clinical Research Associate (CRA) On-Boarding Program - November 19, 2019 - February 04, 2020

EARLY REGISTRATION
Course #: BI13571
November 19, 2019 - February 4, 2020 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Tuesday Evenings. No class December 24, December 31.

Resume support is available as an add-on option! Click here for more details.


Take advantage of our $1615.50 price by registering early!
* After Friday, October 18, 2019, costs are $1795.50.
$1,615.50

Good Clinical Practice: Practical Application and Implementation - November 20, 2019

Course #: BI13695
November 20, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Risk-Based Monitoring: The Data Management Connection - November 20, 2019

Course #: BI13696
November 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning - November 21, 2019

Course #: BI13698
November 21, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors - November 21, 2019

Course #: BI13699
November 21, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

NEW! Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs - November 22, 2019

Course #: BI13700
November 22, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Overseeing Teams and Projects - November 25, 2019

Course #: BI13701
November 25, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Ensuring Success Through Smarter Site Selection and Study Feasibility - November 26, 2019

Course #: BI13702
November 26, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Tools for Trainers: Clinical Research Job-Aids and Checklists - November 26, 2019

Course #: BI13703
November 26, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Cases in Advanced GCP: A Problem-Solving Practicum - December 02, 2019

Course #: BI13704
December 2, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets - December 02, 2019

Course #: BI13705
December 2, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results - December 02, 2019

Course #: BI13765
December 2, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Managing CRAs to Improve Performance and Study Outcomes - December 03, 2019

Course #: BI13706
December 3, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$562.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs - December 03, 2019

Course #: BI13707
December 3, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

eSource and Mobile Technology Initiatives: Data Management Considerations - December 04, 2019

Course #: BI13709
December 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Managing Phase I Clinical Trials - December 04, 2019

Course #: BI13766
December 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools - December 04, 2019

Course #: BI13637
December 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program - December 04, 2019 - February 19, 2020

EARLY REGISTRATION
Course #: BI13580
December 4, 2019 - February 19, 2020 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Wednesday Evenings. No class December 25, January 1.

Resume support is available as an add-on option! Click here for more details.


Take advantage of our $1615.50 price by registering early!
* After Friday, November 1, 2019, costs are $1795.50.
$1,615.50

10-Week CRA & CRC Beginner Program - December 04, 2019 - February 19, 2020

EARLY REGISTRATION
Course #: BI13567
December 4, 2019 - February 19, 2020 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings. No class December 25, January 1. 

Resume support is available as an add-on option! Click here for more details.


Take advantage of our $1615.50 price by registering early!
* After Friday, November 1, 2019, costs are $1795.50.
$1,615.50

NEW! Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs - December 05, 2019

Course #: BI13767
December 5, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Approaches to Address Challenges in Vendor Management - December 05, 2019

Course #: BI13627
December 5, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and an EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials - December 05, 2019

Course #: BI13710
December 5, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

NEW! Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations - December 06, 2019

Course #: BI13768
December 6, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

CRO Partnership Management - December 06, 2019

Course #: BI13617
December 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

ABCs of GCP and the 13 Principles of ICH GCP E6 - December 09, 2019

Course #: BI13712
December 9, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

NEW! Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials - December 09, 2019

Course #: BI13711
December 9, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Risk-Based Site Monitoring - December 09, 2019

Course #: BI13713
December 9, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings - December 09, 2019

Course #: BI13714
December 9, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$562.50

ABCs of Clinical Research for Clinical Administrative Support Staff - December 09, 2019

Course #: BI13715
December 9, 2019 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Strategies for Managing Difficult Clinical Research Sites - December 10, 2019

Course #: BI13716
December 10, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Monitoring Reports: 10 Rules of Effective Report Writing - December 10, 2019

Course #: BI13717
December 10, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques - December 10, 2019

Course #: BI13718
December 10, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$850.50

Use of Electronic Health Record Data in Clinical Investigations - December 11, 2019

Course #: BI13720
December 11, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Quality Systems: A Controlled Approach to GCP Compliance - December 11, 2019

Course #: BI13721
December 11, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

The IND in a CTD/eCTD Format - December 11, 2019

Course #: BI13722
December 11, 2019 | Interactive Web Seminar
2:30 PM - 4:00 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Investigator Initiated Trials: Roles and Responsibilities - December 12, 2019

Course #: BI13723
December 12, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Root Cause Analysis: Applying the Concept for Better Study Compliance Management - December 12, 2019

Course #: BI13724
December 12, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

eTMF Quality Oversight: A Risk-Based Approach - December 13, 2019

Course #: BI13725
December 13, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Auditing Techniques: A Problem-Solving Practicum - December 13, 2019

Course #: BI13726
December 13, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

TMF/eTMF Audit Strategies - December 13, 2019

Course #: BI13727
December 13, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The Revised HHS Common Rule: What You Need to Know Now - December 16, 2019

Course #: BI13728
December 16, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Sponsor Responsibilities for Global Drug Studies - December 17, 2019

Course #: BI13729
December 17, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials - December 18, 2019

Course #: BI13730
December 18, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

NEW! Risk-Based Quality and Compliance Management in Combination Product Trials - December 18, 2019

Course #: BI13770
December 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites - December 19, 2019

Course #: BI13731
December 19, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

Preparation, Management, and Response to Inspections and Audits - January 07, 2020

Course #: BI13732
January 7, 2020 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$940.50

Writing and Updating the Investigator's Brochure - January 08, 2020

Course #: BI13733
January 8, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

30-Hour Clinical Project Management Fundamentals Certification Program - January 09, 2020 - March 12, 2020

EARLY REGISTRATION
Course #: BI13583
January 9 - March 12, 2020 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings.

Resume support is available as an add-on option! Click here for more details.


Take advantage of our $1615.50 price by registering early!
* After Thursday, December 12, 2019, costs are $1795.50.
$1,615.50