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10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series May 24, 2022 - July 26, 2022

Course #: BI14838
May 24 - July 26, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern

Tuesday Mornings.
$1,705.50

Case Report Form Design, Strategy, and Standards May 25, 2022

Course #: BI14991
May 25, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

10-Week CRA & CRC Beginner Program May 25, 2022 - July 27, 2022

Course #: BI14828
May 25 - July 27, 2022 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings.

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

$1,795.50

Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs May 26, 2022

Course #: BI14992
May 26, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Protocol Deviations: Documenting, Managing, and Reporting May 26, 2022

Course #: BI14994
May 26, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program May 27, 2022 - July 29, 2022

Course #: BI14831
May 27 - July 29, 2022 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings.

Resume support is available as an add-on option! Click here for more details.
$1,795.50

The GCPs of Essential Documents May 27, 2022

Course #: BI14993
May 27, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program May 27, 2022 - July 29, 2022

Course #: BI14834
May 27 - July 29, 2022 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
Friday Afternoons.

Resume support is available as an add-on option! Click here for more details.
$1,795.50

Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles May 31, 2022

Course #: BI14995
May 31, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

CAP and CLIA Requirements for Clinical Research Laboratories May 31, 2022

Course #: BI14996
May 31, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Data Quality in Clinical Trials: Rationale and Impact June 1, 2022

Course #: BI14997
June 1, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques June 1, 2022

Course #: BI14998
June 1, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$850.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials June 2, 2022

Course #: BI14999
June 2, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval June 2, 2022 - August 4, 2022

Course #: BI14864
June 2 - August 4, 2022 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Thursday Evenings.
$1,795.50

Implementing Quality Agreements June 3, 2022

Course #: BI15000
June 3, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Good Clinical Practice: Practical Application and Implementation June 6, 2022

Course #: BI15001
June 6, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Electronic Informed Consent Guidance: Regulatory Updates June 6, 2022

Course #: BI15002
June 6, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets June 6, 2022

Course #: BI15003
June 6, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week Fundamentals of Drug Development Series June 6, 2022 - August 15, 2022

Course #: BI14863
June 6 - August 15, 2022 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Monday Evenings. No class July 4.
$1,795.50

Strategies for Remote Auditing of Investigative Sites June 7, 2022 - June 14, 2022

Course #: BI15004
June 7-14, 2022 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
Session 1: June 7, 2022 (8:30 - 11:30 a.m. Eastern);
Session 2: June 14, 2022 (8:30 - 11:30 a.m. Eastern)
$1,075.50

Introduction to Statistics for Non-Statisticians June 7, 2022

Course #: BI15005
June 7, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual June 7, 2022

Course #: BI15006
June 7, 2022 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$661.50

30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols June 7, 2022 - August 9, 2022

Course #: BI14853
June 7 - August 9, 2022 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Tuesday Evenings.
$1,795.50

Incorporating Denials Management into Clinical Research Billing June 8, 2022

Course #: BI15007
June 8, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Principal Investigator Oversight and the Appropriate Delegation of Tasks June 8, 2022

Course #: BI15008
June 8, 2022 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Risk-Based Auditing: Effective Compliance Strategies June 9, 2022

Course #: BI15009
June 9, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Drug Development and FDA Regulations June 9, 2022

Course #: BI15010
June 9, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program June 9, 2022 - August 11, 2022

Course #: BI14850
June 9 - August 11, 2022 | 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

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada June 10, 2022

Course #: BI15011
June 10, 2022 | Interactive Web Seminar
11:30 AM - 1:30 PM Eastern
$661.50

Clinical Research Financial Management for Investigative Sites June 13, 2022

Course #: BI15013
June 13, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

General Data Protection Regulation (GDPR): Developing a Compliant Data Privacy Program - June 14, 2022

Course #: BI15014
June 14, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$562.50

Writing Clinical Study Protocols June 15, 2022

Course #: BI15015
June 15, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Approaches to Address Challenges in Vendor Management June 17, 2022

Course #: BI15016
June 17, 2022 | 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 17, 2022 - August 19, 2022

Course #: BI14842
June 17 - August 19, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern

Friday Mornings.
$1,705.50

Regulatory Intelligence June 17, 2022

Course #: BI15017
June 17, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Strategies for Building High-Performing Clinical Research Teams June 20, 2022

Course #: BI15018
June 20, 2022 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

NEW! 10-Week Establishing a Vendor Qualification and Management Program June 21, 2022 - August 23, 2022

Course #: BI14855
June 21 - August 23, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Tuesday Afternoons.
$1,705.50

Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives June 22, 2022

Course #: BI15020
June 22, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Cases in Advanced GCP: A Problem-Solving Practicum June 23, 2022

Course #: BI15021
June 23, 2022 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Informed Consent Procedure: Lessons Learned from Inspection Findings June 23. 2022

Course #: BI15022
June 23, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Project Management Fundamentals Certification Program June 24, 2022 - September 23, 2022

Course #: BI14848
June 24 - September 23, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Friday Afternoons. No class July 1, July 8, September 2, September 9.

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 May 27, costs are $1795.50.
$1,615.50

Writing and Updating the Investigator's Brochure June 27, 2022

Course #: BI15023
June 27, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Strategies for Effective Remote Monitoring June 28, 2022

Course #: BI15024
June 28, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results June 29, 2022

Course #: BI15025
June 29, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

A Systematic Approach to Study Start-Up: Improving Site Activation June 29, 2022

Course #: BI15026
June 29, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week Conducting and Managing Oncology Clinical Trials June 30, 2022 - September 1, 2022

Course #: BI15071
June 30 - September 1, 2022 | Interactive Web Seminar
1:00 PM - 4:00 PM

Thursday Afternoons.

Take advantage of our $1,615.50 price by registering early!
* After May 27, costs are $1795.50.
$1,615.50

Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations June 30, 2022

Course #: BI15019
June 30, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

ABCs of GCP and the 13 Principles of ICH GCP E6 June 30, 2022

Course #: BI15027
June 30, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

ABCs of Clinical Research for Clinical Administrative Support Staff June 30, 2022

Course #: BI15028
June 30, 2022 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Sponsor Responsibilities for Global Drug Studies July 5, 2022

Course #: BI15029
July 5, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Risk-Based Site Monitoring July 6, 2022

Course #: BI15030
July 6, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Managing Phase I Clinical Trials July 6, 2022

Course #: BI15031
July 6, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

ICH E8 (R1): Designing Quality into Clinical Studies July 7, 2022

Course #: BI15033
July 7, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

ICH E8 (R1): Changes Impacting Sponsors/CROs July 7 2022

Course #: BI15032
July 7, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance - July 8, 2022

Course #: BI15034
July 8, 2022 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs July 8, 2022

Course #: BI15035
July 8, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

15-Hour Clinical Trial Assistant Fundamentals Training Program July 11, 2022 - July 27, 2022

Course #: BI14857
July 11-27, 2022 | 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 10, costs are $1,705.50.
$1,525.50

Writing the Clinical Study Report July 11, 2022

Course #: BI15036
July 11, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Strategies for Having Difficult Conversations July 11, 2022

Course #: BI15037
July 11, 2022 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program July 12, 2022 - September 13, 2022

Course #: BI14832
July 12 - September 13, 2022 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Tuesday Evenings.

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 10, costs are $1795.50.
$1,615.50

FDA Medical Device Approval Process July 12, 2022

Course #: BI15039
July 12, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

State Laws Governing Clinical Trial Regulatory Compliance July 12, 2022

Course #: BI15040
July 12, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management July 12, 2022

Course #: BI15038
July 12, 2022 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$562.50

10-Hour Advanced Clinical Project Management Skills Development July 13, 2022 - August 10, 2022

Course #: BI14859
July 13 - August 10, 2022 | 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 10, costs are $1,615.50.
$1,435.50

Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation July 13, 2022

Course #: BI15041
July 13, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning July 14, 2022

Course #: BI15042
July 14, 2022 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Monitoring Oncology Clinical Trials July 14, 2022

Course #: BI15043
July 14, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators July 18, 2022

Course #: BI15045
July 18, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Coaching Skills for Leaders July 18, 2022

Course #: BI15046
July 18, 2022 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites July 19, 2022

Course #: BI15048
July 19, 2022 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

FDA Drug Approval Process July 19, 2022

Course #: BI15044
July 19, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Preparation, Management, and Response to Inspections and Audits July 19, 2022

Course #: BI15047
July 19, 2022 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$940.50

Adverse Event Monitoring for CRAs July 19, 2022

Course #: BI15059
July 19, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Introduction to Data Management July 20, 2022

Course #: BI15049
July 20, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Essential Documentation in Clinical Trials at Research Sites July 21, 2022

Course #: BI15054
July 21, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Preparing Clinical Research Sites for FDA Inspections July 21, 2022

Course #: BI15050
July 21, 2022 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$562.50

Source Documentation: What is Adequate and Accurate? July 21, 2022

Course #: BI15052
July 21, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Managing CRAs to Improve Performance and Study Outcomes July 21, 2022

Course #: BI15051
July 21, 2022 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$562.50

Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs July 25, 2022

Course #: BI15053
July 25, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Adverse Events: Best Practices for Reporting and Communicating Safety Information to IRBs July 25, 2022

Course #: BI15055
July 25, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

Quality Systems: A Controlled Approach to GCP Compliance July 25, 2022

Course #: BI15056
July 25, 2022 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$661.50

10-Week CRA & CRC Beginner Program July 26, 2022 - September 27, 2022

Course #: BI14829
July 25 - September 27, 2022 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. 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 June 24, costs are $1795.50.
$1,615.50

30-Hour Clinical Research Auditing Certification Program July 26, 2022 - September 27, 2022

Course #: BI14851
July 26 - September 27, 2022 | 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.
$1,615.50

Investigator Initiated Trials: Roles and Responsibilities July 26, 2022

Course #: BI15057
July 26, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components July 26, 2022

Course #: BI15058
July 26, 2022 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research July 27, 2002 - August 26, 2022

Course #: BI14840
July 27 - August 26, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Wednesday and Friday 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 24, costs are $1,705.50.
$1,525.50

Strategies for Managing Difficult Clinical Research Sites July 27, 2022

Course #: BI15060
July 27, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

FDA Requirements for Electronic Source Data in Clinical Investigations July 27, 2022

Course #: BI15062
July 27, 2022 | Interactive Web Seminar
9:30 - 11:30 AM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management July 27, 2022

Course #: BI15063
July 27, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

"Risk-Based Thinking": How Monitors Can Develop an Auditor's Perspective July 27, 2022

Course #: BI15061
July 27, 2022 | Interactive Web Seminar
3:30 PM - 5:00 PM Eastern
$661.50

WORKSHOP: Case Report Form Design, Strategy, and Standards July 28, 2022

Course #: BI15064
July 28, 2022 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern

Take advantage of our $765.00 price by registering early!
* After June 24, costs are $945.00
$765.00

Use of Notes to File in Clinical Trial Essential Documentation July 28, 2022

Course #: BI15065
July 28, 2022 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$751.50

Monitoring Visit Reports for Medical Device Studies July 28, 2022

Course #: BI15066
July 28, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions) July 29, 2022

Course #: BI15067
July 29, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Auditing Techniques: A Problem-Solving Practicum July 29, 2022

Course #: BI15069
July 29, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance July 29, 2022

Course #: BI15068
July 29, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50
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