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Preparing Clinical Research Sites for FDA Inspections

Course #: BI13292
November 19, 2018 | 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

Monitoring Visit Reports for Medical Device Studies

Course #: BI13293
November 19, 2018 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

ABCs of Clinical Research for Clinical Administrative Support Staff

Course #: BI13294
November 20, 2018 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

ABCs of GCP and the 13 Principles of ICH GCP E6

Course #: BI13295
November 20, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

FDA Medical Device Approval Process

Course #: BI13296
November 20, 2018 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Case Report Form Design, Strategy, and Standards Workshop

Course #: BI13297
November 27, 2018 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

Risk-Based Monitoring: The Data Management Connection

Course #: BI13298
November 28, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program

Course #: BI13300
November 29, 2018 - February 14, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Thursday Mornings. No Class December 27, January 3.

$1,795.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

Course #: BI13299
November 29, 2018 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

Negotiation Skills for Clinical Research Professionals

Course #: BI13278
November 29, 2018 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Trial Master Files: Why They Are Important and How to Organize Them Workshop

Course #: BI13301
November 30, 2018 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques

Course #: BI13302
December 3, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$850.50

cGMP for the Quality Control Laboratory

Course #: BI13303
December 4, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

Course #: BI13304
December 5, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Course #: BI13305
December 5, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate?

Course #: BI13306
December 6, 2018 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Monitoring Plan Development

Course #: BI13307
December 6, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program

Course #: BI13308
December 7, 2018 - February 22, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Friday Mornings. No class December 28, January 4.

$1,795.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

Course #: BI13309
December 7, 2018 - February 22, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Friday Afternoons. No class December 28, January 4.

$1,795.50

Overseeing Teams and Projects

Course #: BI13310
December 7, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Monitoring Reports: 10 Rules of Effective Report Writing

Course #: BI13311
December 10, 2018 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Course #: BI13312
December 10, 2018 | 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

Strategies for Managing Difficult Clinical Research Sites

Course #: BI13314
December 10, 2018 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

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

Course #: BI13313
December 10, 2018 | 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

Sponsor Responsibilities for Global Drug Studies

Course #: BI13315
December 10, 2018 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

Course #: BI13316
December 11, 2018 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

Drug Development and FDA Regulations

Course #: BI13317
December 11, 2018 | Interactive Web Seminar
12:30 PM - 3:30 PM Eastern
$661.50

EU Clinical Trial Regulation 536/2014: Trial Management and Monitoring Requirements

Course #: BI13318
December 11-13, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Day 1: December 11, 2018 (1:00 - 3:00 p.m. Eastern); Day 2: December 13, 2018 (1:00 - 3:00 p.m. Eastern)

$940.50

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings

Course #: BI13319
December 12, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$562.50

SDTM and CDASH: What's the Connection?

Course #: BI13320
December 12, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Quality Systems: A Controlled Approach to GCP Compliance

Course #: BI13322
December 13, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13323
December 13, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

NEW! 10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research

Course #: BI13321
December 13, 2018 - March 7, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons. No class December 27, January 3, and February 21..

$1,795.50

TMF/eTMF Audit Strategies

Course #: BI13324
December 14, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance

Course #: BI13325
December 14, 2018 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

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

Course #: BI13326
December 14, 2018 | 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

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and EMA Reflection Paper Risk Based Quality Management in Clinical Trials

Course #: BI13327
December 14, 2018 | 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

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

Course #: BI13328
December 17, 2018 | 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

Introduction to Statistics for Non-Statisticians

Course #: BI13329
December 18, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

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

Course #: BI13330
December 19, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Good Laboratory Practice for Non-Clinical Studies

Course #: BI13331
January 8-10, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Day 1: January 8, 2019 (1:00 - 3:00 p.m. Eastern); Day 2: January 10, 2019 (1:00 - 3:00 p.m. Eastern)

$940.50

NEW! Incorporating Denials Management into Clinical Research Billing

Course #: BI13361
January 8, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

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

Course #: BI13332
January 10, 2019 | Interactive Web Seminar
11:00 AM - 1:30 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

30-Hour Clinical Project Management Fundamentals Certification Program

EARLY REGISTRATION
Course #: BI13382
January 10 - March 21, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings. No class January 24.


Take advantage of our $1615.50 price by registering early!
* After Friday, December 7, 2018, costs are $1795.50.
$1,615.50

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

Course #: BI13333
January 11, 2019 | Interactive Web Seminar
11:00 AM - 1:30 PM Eastern
$751.50

eTMF Quality Oversight: A Risk-Based Approach

Course #: BI13334
January 11, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Risk-Based Site Monitoring

Course #: BI13335
January 14, 2019 | Interactive Web Seminar
12:00 PM - 1:30 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

The Revised HHS Common Rule: What You Need to Know Now

Course #: BI13336
January 14, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Managing CRAs to Improve Performance and Study Outcomes

Course #: BI13337
January 14, 2019 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$562.50

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

Course #: BI13339
January 15, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Introduction to Clinical Research

Course #: BI13338
January 15, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Writing Clinical Study Protocols

Course #: BI13340
January 16, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Adverse Event Monitoring for CRAs

Course #: BI13389
January 16, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program

EARLY REGISTRATION
Course #: BI13341
January 16 - March 20, 2019 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Wednesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, December 14, 2018, costs are $1795.50.
$1,615.50

10-Week CRA & CRC Beginner Program

EARLY REGISTRATION
Course #: BI13342
January 16 - March 20, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, December 14, 2018, costs are $1795.50.
$1,615.50

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance

Course #: BI13343
January 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Monitoring Oncology Clinical Trials

Course #: BI13390
January 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Protocol Deviations: Documenting, Managing, and Reporting

Course #: BI13344
January 17, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

Electronic Informed Consent Guidance: Regulatory Updates

Course #: BI13345
January 18, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Investigational Product Accountability Best Practices

Course #: BI13346
January 21, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

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

Course #: BI13348
January 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

The GCPs of Essential Documents

Course #: BI13347
January 21, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Introduction to Data Management

Course #: BI13349
January 23, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Writing the Clinical Study Report

Course #: BI13350
January 23, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

NEW! Advanced Clinical Research Coordinator Training: Moving Your Career to the Next Level

Course #: BI13351
January 24, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Strategies for Active Listening

Course #: BI13362
January 24, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management

Course #: BI13352
January 28, 2019 | Interactive Web Seminar
12:00 PM - 2:00 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

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

Course #: BI13353
January 29, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Final ICH GCP E6 R2: Impact on Clinical Data Management

Course #: BI13354
January 30, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

Course #: BI13355
January 31, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Coaching Skills for Leaders

Course #: BI13363
January 31, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Clinical Research Financial Management for Investigative Sites

Course #: BI13556
February 4, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

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

Course #: BI13391
February 5, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series

EARLY REGISTRATION
Course #: BI13375
February 5 - April 8, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Tuesday Afternoons.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 4, 2019, costs are $1795.50.
$1,615.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program

EARLY REGISTRATION
Course #: BI13378
February 7 - April 11, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Thursday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 4, 2019, costs are $1795.50.
$1,615.50

Cases in Advanced GCP: A Problem-Solving Practicum

Course #: BI13392
February 7, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

ABCs of Clinical Research for Clinical Administrative Support Staff

Course #: Bi13393
February 11, 2019 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

ABCs of GCP and the 13 Principles of ICH GCP E6

Course #: BI13394
February 11, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Establishing Quality Tolerance Limits

Course #: BI13545
February 12, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate?

Course #: BI13395
February 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank

Course #: BI13396
February 19, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

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

Course #: BI13397
February 19, 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

Course #: BI13398
February 19, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Good Clinical Practice: Practical Application and Implementation

Course #: BI13399
February 20, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13400
February 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

Use of Notes to File in Clinical Trial Essential Documentation

Course #: BI13401
February 21, 2019 | Interactive Web Seminar
8:30 AM - 10:00 AM Eastern
$751.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13402
February 21, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Monitoring Plan Development

Course #: BI13403
February 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13384
February 21 - April 25, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings.


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

NEW! Auditing Techniques: A Problem-Solving Practicum

Course #: BI13550
February 22, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

NEW! 10-Week Clinical Research Financial Certification Program: Setting Up Compliant Financial Operations and Budgets

EARLY REGISTRATION
Course #: BI13387
February 25, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class April 15.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 25, 2019, costs are $1795.50.
$1,615.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

Course #: BI13404
February 28, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

EARLY REGISTRATION
Course #: BI13372
March 1 - May 10, 2019 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class April 12.


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

10-Week Clinical Research Associate (CRA) On-Boarding Program

EARLY REGISTRATION
Course #: BI13371
March 1 - May 10, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Friday Afternoons. No class April 12.


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

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13405
March 5, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research

EARLY REGISTRATION
Course #: BI13376
March 5 - May 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Tuesday Mornings. No class April 2.


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

Approaches to Address Challenges in Vendor Management

Course #: BI13406
March 5, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

Introduction to Statistics for Non-Statisticians

Course #: BI13407
March 5, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

CRO Partnership Management

Course #: BI13408
March 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Tools for Trainers: Clinical Research Job-Aids and Checklists

Course #: BI13409
March 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50