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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

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

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

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

Use of Notes to File in Clinical Trial Essential Documentation - January 13, 2020

Course #: BI13734
January 13, 2020 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$751.50

Drug Development and FDA Regulations - January 13, 2020

Course #: BI13735
January 13, 2020 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

10-Week Clinical Research Financial Certification Program: Setting Up Compliant Financial Operations and Budgets - January 13, 2020 - March 16, 2020

EARLY REGISTRATION
Course #: BI13588
January 13 - March 16, 2020 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons.


Take advantage of our $1615.50 price by registering early!
* After Friday, December 13, 2019, costs are $1795.50.
$1,615.50

State Laws Governing Clinical Trial Regulatory Compliance - January 13, 2020

Course #: BI13771
January 13, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance - January 14, 2020

Course #: BI13736
January 14, 2020 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components - January 14, 2020

Course #: BI13738
January 14, 2020 | Interactive Web Seminar
12:30 PM - 3:00 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.

$751.50

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance - January 14, 2020

Course #: BI13737
January 14, 2020 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Essential Documentation in Clinical Trials at Research Sites - January 14, 2020

Course #: BI13740
January 14, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Writing the Clinical Study Report - January 15, 2020

Course #: BI13741
January 15, 2020 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada - January 15, 2020

Course #: BI13742
January 15, 2020 | 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

Source Documentation: What is Adequate and Accurate? - January 15, 2020

Course #: BI13743
January 15, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Electronic Informed Consent Guidance: Regulatory Updates - January 16, 2020

Course #: BI13744
January 16, 2020 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance - January 16, 2020

Course #: BI13745
January 16, 2020 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings - January 17, 2020

Course #: BI13746
January 17, 2020 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry - January 17, 2020

Course #: BI13747
January 17, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50
$751.50

Coaching Skills for Leaders - January 21, 2020

Course #: BI13739
January 21, 2020 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Preparing Clinical Research Sites for FDA Inspections - January 21, 2020

Course #: BI13749
January 21, 2020 | Interactive Web Seminar
12:00 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.

$562.50

Strategies for Having Difficult Conversations - January 21, 2020

Course #: BI13750
January 21, 2020 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management - January 22, 2020

Course #: BI13751
January 22, 2020 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Writing Clinical Study Protocols - January 22, 2020

Course #: BI13752
January 22, 2020 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Subject Recruitment: Proactive Project Plans and Issues Management - January 28, 2020

Course #: BI13753
January 28, 2020 | Interactive Web Seminar
1:00 PM - 3:00 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.

$562.50

Incorporating Denials Management into Clinical Research Billing - January 28, 2020

Course #: BI13754
January 28, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Introduction to Data Management - January 29, 2020

Course #: BI13755
January 29, 2020 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

NEW! A Systematic Approach to Study Start-Up: Improving Site Activation - January 29, 2020

Course #: BI13772
January 29, 2020 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Monitoring Oncology Clinical Trials - January 30, 2020

Course #: BI13756
January 30, 2020 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50