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ABCs of Clinical Research for Clinical Administrative Support Staff June 5, 2023

Course #: BI15632
June 5, 2023 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Drug Development and FDA Regulations June 7, 2023

Course #: BI15637
June 7, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Introduction to Statistics for Non-Statisticians June 7, 2023

Course #: BI15636
June 7, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets June 7, 2023

Course #: BI15639
June 7, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Incorporating Denials Management into Clinical Research Billing June 7, 2023

Course #: BI15638
June 7, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Principal Investigator Oversight and the Appropriate Delegation of Tasks June 8, 2023

Course #: BI15640
June 8, 2023 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program June 8 - August 10, 2023

Course #: BI15641
June 8 - August 10, 2023 | 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.

$1,795.50

Strategies for Remote Auditing of Investigative Sites June 13 - 20, 2023

Course #: BI15642
June 13 - 20, 2023 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Session 1: June 13, 2023 (8:30 a.m. - 11:30 a.m. Eastern); Session 2: June 20, 2023 (8:30 a.m. - 11:30 a.m. Eastern)

$1,075.50

NEW! Overcoming Site Challenges: Managing Sponsor Payment Delays June 13, 2023

Course #: BI15714
June 13, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$751.50

NEW! Utilization of Real World Evidence (RWE) and Real Word Data (RWD) and Regulations June 13, 2023

Course #: BI15715
June 13, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$751.50

Approaches to Address Challenges in Vendor Management June 15, 2023

Course #: BI15643
June 15, 2023 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program June 16 - August 18, 2023

Course #: BI15645
June 16 - August 18, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Friday Afternoons.

$1,705.50

Strategies for Building High-Performing Clinical Research Teams June 19, 2023

Course #: BI15646
June 19, 2023 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

10-Week Establishing a Vendor Qualification and Management Program June 20 - August 29, 2023

Course #: BI15647
June 20 - August 29, 2023 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Tuesday Mornings. No class July 4.

$1,705.50

Risk-Based Auditing: Effective Compliance Strategies June 21, 2023

Course #: BI15648
June 21, 2023 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Strategies for Effective Remote Monitoring June 21, 2023

Course #: BI15649
June 21, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Cases in Advanced GCP: A Problem-Solving Practicum June 22, 2023

Course #: BI15650
June 22, 2023 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives June 22, 2023

Course #: BI15651
June 22, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Project Management Fundamentals Certification Program June 23 - September 1, 2023

Course #: BI15652
June 23 - September 1, 2023 | Interactive Web Seminar
11:00 AM - 2:00 PM Eastern

Friday Afternoons. No class July 7.

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

$1,795.50

Regulatory Intelligence June 26, 2023

Course #: BI15653
June 26, 2023 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations June 26, 2023

Course #: BI15654
June 26, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Writing and Updating the Investigator's Brochure June 27, 2023

Course #: BI15656
June 27, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual June 27, 2023

Course #: BI15655
June 27, 2023 | Interactive Web Seminar
2:00 PM - 4:00 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 June 28, 2023

Course #: BI15657
June 28, 2023 | Interactive Web Seminar
11:30 AM - 1:30 PM Eastern
$661.50

10-Week Conducting and Managing Oncology Clinical Trials June 29 - August 31, 2023

Course #: BI15658
June 29 - August 31, 2023 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern

Thursday Mornings.

$1,795.50

Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results June 29, 2023

Course #: BI15659
June 29, 2023 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

A Systematic Approach to Study Start-Up: Improving Site Activation June 29, 2023

Course #: BI15660
June 29, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Risk-Based Site Monitoring July 6, 2023

Course #: BI15661
July 6, 2023 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$661.50

Sponsor Responsibilities for Global Drug Studies July 6, 2023

Course #: BI15662
July 6, 2023 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management July 6, 2023

Course #: BI15673
July 6, 2023 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$562.50

ICH E8 (R1): Designing Quality into Clinical Studies July 10, 2023

Course #: BI15663
July 10, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

ICH E8 (R1): Changes Impacting Sponsors/CROs July 10, 2023

Course #: BI15665
July 10, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

15-Hour Clinical Trial Assistant Fundamentals Training Program July 10 - 26, 2023

Course #: BI15668
July 10 - 26, 2023 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern

Monday and Wednesday Afternoons.

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

Take advantage of our $1,525.50 price by registering early!
* After June 09, costs a < text >...
$1,525.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning July 11, 2023

Course #: BI15667
July 11, 2023 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Writing the Clinical Study Report July 11, 2023

Course #: BI15666
July 11, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Quality Systems: A Controlled Approach to GCP Compliance July 11, 2023

Course #: BI15669
July 11, 2023 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program July 11 - September 19, 2023

Course #: BI15670
July 11 - September 19, 2023 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Tuesday Evenings. No class September 5.

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

Take advantage of our $1,615.50 price by registering early!
* After < text >...
$1,615.50

Monitoring Oncology Clinical Trials July 12, 2023

Course #: BI15675
July 12, 2023 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Strategies for Having Difficult Conversations July 12, 2023

Course #: BI15672
July 12, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

State Laws Governing Clinical Trial Regulatory Compliance July 12, 2023

Course #: BI15671
July 12, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Hour Advanced Clinical Project Management Skills Development July 12 - August 9, 2023

Course #: BI15674
July 12 - August 9, 2023 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern

Wednesday Evenings.

Take advantage of our $1,435.50 price by registering early!
* After June 09, costs are $1,615.50.
$1,435.50

Use of Notes to File in Clinical Trial Essential Documentation July 13, 2023

Course #: BI15703
July 13, 2023 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$751.50

Research Billing Processing: Leveraging Technology to Maintain Compliance and Mitigate Risk July 13, 2023

Course #: BI15676
July 13, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

FDA Drug Approval Process July 14, 2023

Course #: BI15664
July 14, 2023 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

FDA Medical Device Approval Process July 17, 2023

Course #: BI15678
July 17, 2023 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators July 18, 2023

Course #: BI15679
July 18, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Source Documentation: What is Adequate and Accurate? July 18, 2023

Course #: BI15685
July 18, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Introduction to Data Management July 19, 2023

Course #: BI15681
July 19, 2023 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Auditing Techniques: A Problem-Solving Practicum July 19, 2023

Course #: BI15684
July 19, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Essential Documentation in Clinical Trials at Research Sites July 20, 2023

Course #: BI15692
July 20, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Preparing Clinical Research Sites for FDA Inspections July 20, 2023

Course #: BI15686
July 20, 2023 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

Managing Phase I Clinical Trials July 20, 2023

Course #: BI15687
July 20, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

ICH GCP E6 R2 and R3 Updates: Impact on Clinical Data Management July 20, 2023

Course #: BI15688
July 20, 2023 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Managing CRAs to Improve Performance and Study Outcomes July 20, 2023

Course #: BI15689
July 20, 2023 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$562.50

Coaching Skills for Leaders July 21, 2023

Course #: BI15677
July 21, 2023 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Adverse Event Monitoring for CRAs July 24, 2023

Course #: BI15690
July 24, 2023 | Interactive Web Seminar
10:00 AM - 12:00 PM Eastern
$661.50

10-Week CRA & CRC Beginner Program July 24 - October 2, 2023

Course #: BI15691
July 24 - October 2, 2023 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class September 4.

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

Take advantage of our $1,615.50 price by registering early!
* After J < text >...
$1,615.50

Adverse Events: Best Practices for Reporting and Communicating Safety Information to IRBs July 25, 2023

Course #: BI15693
July 25, 2023 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$562.50

20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research July 25 - August 24, 2023

Course #: BI15697
July 25 - August 24, 2023 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Tuesday and Thursday Mornings. 

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

Take advantage of our $1,525.50 price by registering early!
* After June 23, < text >...
$1,525.50

NEW! ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors July 25, 2023

Course #: BI15680
July 25, 2023 | Interactive Web Seminar
10:00 AM - 11:30 AM Eastern
$661.50

Investigator Initiated Trials: Roles and Responsibilities July 25, 2023

Course #: BI15694
July 25, 2023 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program July 25 - September 26, 2023

Course #: BI15695
July 25 - September 26, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Tuesday Afternoons.

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

Take advantage of our $1,615.50 price by registering early!
* After June 23, costs are < text >...
$1,615.50

ICH GCP E6 R2 and R3 Updates: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions) July 26, 2023

Course #: BI15700
July 26, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Strategies for Managing Difficult Clinical Research Sites July 26, 2023

Course #: BI15696
July 26, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components July 26, 2023

Course #: BI15699
July 26, 2023 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

FDA Requirements for Electronic Source Data in Clinical Investigations July 26, 2023

Course #: BI15698
July 26, 2023 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

ICH GCP E6 R2 and R3 Updates: Changes Impacting Sponsors/CROs July 26, 2023

Course #: BI15702
July 26, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Monitoring Visit Reports for Medical Device Studies July 27, 2023

Course #: BI15701
July 27, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

WORKSHOP: Case Report Form Design, Strategy, and Standards July 27, 2023

Course #: BI15704
July 27, 2023 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
Take advantage of our $765.00 price by registering early!
* After June 23, costs are $945.00.
$765.00

ICH GCP E6 R2 and R3 Updates: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites July 27, 2023

Course #: BI15683
July 27, 2023 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

ICH GCP E6 R2 and R3 Updates: Sponsor Quality Management – Risk-Based/Risk Management Requirements and Approaches for Compliance July 28, 2023

Course #: BI15707
July 28, 2023 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance July 31, 2023

Course #: BI15706
July 31, 2023 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective July 31, 2023

Course #: BI15705
July 31, 2023 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Preparation, Management, and Response to Inspections and Audits July 31, 2023

Course #: BI15682
July 31, 2023 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$940.50
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