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Cases in Advanced GCP: A Problem-Solving Practicum September 28, 2022

Course #: BI15284
September 28, 2022 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Electronic Informed Consent Guidance: Regulatory Updates September 28, 2022

Course #: BI15263
September 28, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management September 28, 2022

Course #: BI15285
September 28, 2022 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$562.50

10-Week CRA & CRC Beginner Program September 28 - December 7, 2022

Course #: BI15283
September 28 - December 7, 2022 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings. No class November 23.

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

$1,795.50

ABCs of GCP and the Principles of ICH GCP E6 September 29, 2022

Course #: BI15288
September 29, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

ABCs of Clinical Research for Clinical Administrative Support Staff September 29, 2022

Course #: BI15287
September 29, 2022 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Clinical Research Financial Management for Investigative Sites September 29, 2022

Course #: BI15289
September 29, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program September 29 - December 8, 2022

Course #: BI15286
September 29 - December 8, 2022 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings. No class November 24, 2022.

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

$1,795.50

10-Week Clinical Research Associate (CRA) On-Boarding Program September 30 - December 9, 2022

Course #: BI15290
September 30 - December 9, 2022 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class November 25.

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

$1,795.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning September 30, 2022

Course #: BI15291
September 30, 2022 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
$751.50

State Laws Governing Clinical Trial Regulatory Compliance September 30, 2022

Course #: BI15292
September 30, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Monitoring Oncology Clinical Trials October 3, 2022

Course #: BI15293
October 3, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Establishing Quality Tolerance Limits October 4, 2022

Course #: BI15295
October 4, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

NEW! ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors October 4, 2022

Course #: BI15458
October 4, 2022 | Interactive Web Seminar
10:00 AM - 11:30 AM Eastern
$661.50

10-Week ICH GCP E6: Risk-Based Monitoring Plan Development Series October 4 - December 6, 2022

Course #: BI15294
October 4 - December 6, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern

Tuesday Afternoons.

$1,705.50

Adverse Events: Best Practices for Reporting and Communicating Safety Information to IRBs October 5, 2022

Course #: BI15324
October 5, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

Writing the Clinical Study Report October 5, 2022

Course #: BI15296
October 5, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Project Management Fundamentals Certification Program October 6 - December 15, 2022

Course #: BI15297
October 6 - December 15, 2022 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings. No class November 24. 

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

$1,795.50

Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation October 7, 2022

Course #: BI15298
October 7, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Medical Writing Fundamentals: How to Write Regulatory Documents October 10, 2022

Course #: BI15299
October 10, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Auditing Techniques: A Problem-Solving Practicum October 11, 2022

Course #: BI15300
October 11, 2022 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

ICH GCP E6 R2 and R3 Updates: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites October 12, 2022

Course #: BI15301
October 12, 2022 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

ICH E8 (R1): Changes Impacting Sponsors/CROs October 12, 2022

Course #: BI15302
October 12, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

ICH E8 (R1): Designing Quality into Clinical Studies October 12, 2022

Course #: BI15303
October 12, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Sponsor Responsibilities for Global Drug Studies October 13, 2022

Course #: BI15304
October 13, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance October 14, 2022

Course #: BI15306
October 14, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

Risk-Based Site Monitoring October 17, 2022

Course #: BI15310
October 17, 2022 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$661.50

Case Report Form Design, Strategy, and Standards Workshop October 17, 2022

Course #: BI15312
October 17, 2022 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

Preparing Clinical Research Sites for FDA Inspections October 17, 2022

Course #: BI15309
October 17, 2022 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

Strategies for Managing Difficult Clinical Research Sites October 17, 2022

Course #: BI15311
October 17, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

Investigator Initiated Trials: Roles and Responsibilities October 17, 2022

Course #: BI15308
October 17, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Essential Documentation in Clinical Trials at Research Sites October 17, 2022

Course #: BI15307
October 17, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components October 18, 2022

Course #: BI15314
October 18, 2022 | Interactive Web Seminar
8:30 AM - 11:00 AM Eastern
$751.50

Use of Notes to File in Clinical Trial Essential Documentation October 18, 2022

Course #: BI15317
October 18, 2022 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$751.50

Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs October 18, 2022

Course #: BI15315
October 18, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Introduction to Data Management October 18, 2022

Course #: BI15316
October 18, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Coaching Skills for Leaders October 18, 2022

Course #: BI15313
October 18, 2022 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$661.50

10-Hour Advanced Clinical Project Management Skills Development October 19 - November 16, 2022

Course #: BI15318
October 19 - November 16, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern

Wednesday Mornings.

$1,615.50

Managing Phase I Clinical Trials October 20, 2022

Course #: BI15321
October 20, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Quality Systems: A Controlled Approach to GCP Compliance October 20, 2022

Course #: BI15322
October 20, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

10-Week Fundamentals of Drug Development Series October 20, 2022 - January 12, 2023

Course #: BI15319
October 20, 2022 - January 12, 2023 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Thursday Afternoons. No class November 24, December 22, December 29.

$1,795.50

10-Hour Clinical Trial Start-Up Series October 21 - November 18, 2022

Course #: BI15323
October 21 - November 18, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Friday Mornings.

$1,615.50

ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance October 24, 2022

Course #: BI15325
October 24, 2022 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Managing CRAs to Improve Performance and Study Outcomes October 25, 2022

Course #: BI15320
October 25, 2022 | Interactive Web Seminar
9:30 AM - 12:00 PM Eastern
$562.50

Strategies for Having Difficult Conversations October 25, 2022

Course #: BI15327
October 25, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective October 28, 2022

Course #: BI15328
October 28, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Monitoring Reports: 10 Rules of Effective Report Writing October 31, 2022

Course #: BI15334
October 31, 2022 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

ICH GCP E6 R2 and R3 Updates: Changes Impacting Sponsors/CROs October 31, 2022

Course #: BI15332
October 31, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

15-Hour Clinical Trial Assistant Fundamentals Training Program October 31 - November 16, 2022

Course #: BI15329
October 31 - November 16, 2022 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern

Monday and Wednesday Mornings.

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

Take advantage of our $1525.50 price by registering early!
* After September 30, costs are $1705.50.
$1,525.50

Monitoring Plan Development October 31, 2022

Course #: BI15333
October 31, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Root Cause Analysis: Applying the Concept for Better Study Compliance Management October 31, 2022

Course #: BI15335
October 31, 2022 | Interactive Web Seminar
3:00 PM - 5:30 PM Eastern
$562.50

30-Hour Clinical Research Auditing Certification Program November 1, 2022 - January 10, 2023

Course #: BI15337
November 1, 2022 - January 10, 2023 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Tuesday Mornings. No class December 27.

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 September 30, costs are $1795.50.
$1,615.50

Source Documentation: What is Adequate and Accurate? November 1, 2022

Course #: BI15342
November 1, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Adverse Event Monitoring for CRAs November 1, 2022

Course #: BI15339
November 1, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts November 1, 2022

Course #: BI15341
November 1, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance November 1, 2022

Course #: BI15340
November 1, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

A Systematic Approach to Study Start-Up: Improving Site Activation November 1, 2022

Course #: BI15338
November 1, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research November 1 - December 6, 2022

Course #: BI15336
November 1 - December 6, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Tuesday and Thursday Afternoons. No class November 24.

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

Take advantage of our $1525.50 price by registering early!
* After September 30, costs are $1705.50.
$1,525.50

Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials November 2, 2022

Course #: BI15345
November 2, 2022 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$661.50

ICH GCP E6 R2 and R3 Updates: Impact on Clinical Data Management November 2, 2022

Course #: BI15344
November 2, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs November 2, 2022

Course #: BI15347
November 2, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Strategies for Active Listening November 2, 2022

Course #: BI15346
November 2, 2022 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program November 2, 2022 - January 25, 2023

Course #: BI15343
November 2, 2022 - January 25, 2023 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Wednesday Evenings. No class November 23, December 21, December 28.

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 September 30, costs are $1795.50.
$1,615.50

Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management November 3, 2022

Course #: BI15348
November 3, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies November 3, 2022

Course #: BI15349
November 3, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$751.50

FDA Requirements for Electronic Source Data in Clinical Investigations November 3, 2022

Course #: BI15350
November 3, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program November 4, 2022 - January 27, 2023

Course #: BI15351
November 4, 2022 - January 27, 2023 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern

Friday Mornings.  No class November 25, December 23, December 30.

Take advantage of our $1525.50 price by registering early!
* After October 07, costs are $1705.50.
$1,525.50

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings November 4, 2022

Course #: BI15352
November 4, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$562.50

The Fundamentals of Clinical Research Project Management November 7, 2022

Course #: BI15354
November 7, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

The GCPs of Essential Documents November 7, 2022

Course #: BI15355
November 7, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

12-Hour Clinical Trial Management Series November 7 - December 19, 2022

Course #: BI15353
November 7 - December 19, 2022 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern

Monday Evenings. No class December 12.

Take advantage of our $1435.50 price by registering early!
* After October 07, costs are $1615.50.
$1,435.50

Overseeing Teams and Projects November 8, 2022

Course #: BI15358
November 8, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Sponsor Management of Investigator Non-Compliance November 8, 2022

Course #: BI15359
November 8, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Case Report Form Design, Strategy, and Standards November 8, 2022

Course #: BI15357
November 8, 2022 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols November 8, 2022 - January 17, 2023

Course #: BI15356
November 8, 2022 - January 17, 2023 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Tuesday Evenings. No class December 27.

Take advantage of our $1615.50 price by registering early!
* After October 07, costs are $1795.50.
$1,615.50

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors November 9, 2022

Course #: BI15360
November 9, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

The IND in a CTD/eCTD Format November 10, 2022

Course #: BI15362
November 10, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Effective Use of Tools, Job Aids, Process Maps, and Checklists for Project Managers and Clinical Research Teams November 10, 2022

Course #: BI15361
November 10, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Introduction to Clinical Research November 11, 2022

Course #: BI15366
November 11, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Developing Clinical Study Budgets for Sponsors November 11, 2022

Course #: BI15364
November 11, 2022 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

eTMF Implementation Strategies November 11, 2022

Course #: BI15365
November 11, 2022 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$751.50

Building Relationships with Clinical Research Sites November 14, 2022

Course #: BI15367
November 14, 2022 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

CAP and CLIA Requirements for Clinical Research Laboratories November 14, 2022

Course #: BI15368
November 14, 2022 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Leading Teams in a Changing Clinical Research Environment November 15, 2022

Course #: BI15369
November 15, 2022 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools November 15, 2022

Course #: BI15370
November 15, 2022 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Risk-Based Quality and Compliance Management in Combination Product Trials November 16, 2022

Course #: BI15373
November 16, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155 November 16, 2022

Course #: BI15372
November 16, 2022 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval November 16, 2022 - February 8, 2023

Course #: BI15371
November 16, 2022 - February 8, 2023 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Wednesday Evenings. No class November 23, December 21, December 28.

Take advantage of our $1615.50 price by registering early!
* After October 14, costs are $1795.50.
$1,615.50

Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA November 17, 2022

Course #: BI15374
November 17, 2022 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$661.50

CRO Partnership Management November 18, 2022

Course #: BI15375
November 18, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Investigational Product Accountability Best Practices November 18, 2022

Course #: BI15382
November 18, 2022 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring November 21, 2022

Course #: BI15376
November 21, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Negotiation Skills for Clinical Research Professionals November 28, 2022

Course #: BI15377
November 28, 2022 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Current FDA and EMA Inspection Findings: Lessons Learned November 29, 2022

Course #: BI15378
November 29, 2022 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

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

Course #: BI15379
November 30, 2022 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques November 30, 2022

Course #: BI15381
November 30, 2022 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$850.50