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NEW! Strategies for Having Difficult Conversations

Course #: BI13357
September 20, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

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

Course #: BI13233
September 25 - November 27, 2018 | Interactive Web Seminar
10:30 AM - 12:30 PM Eastern

Tuesday Mornings.

$1,795.50

Writing Clinical Study Protocols

Course #: BI13234
September 26, 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 #: BI13235
September 27, 2018 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Writing the Clinical Study Report

Course #: BI13236
September 27, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

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

Course #: BI13237
September 27 - December 6, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons. No class November 22.

$1,795.50

Developing Clinical Study Budgets for Sponsors

Course #: BI13238
September 28, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

HIPAA Compliance Monitoring and Auditing

Course #: BI13240
October 1, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Introduction to Clinical Research

Course #: BI13239
October 1, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program

Course #: BI13241
October 3 - December 12, 2018 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Wednesday Mornings. No Class November 21.

$1,795.50

Writing and Updating the Investigator's Brochure

Course #: BI13242
October 3, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

10-Week CRA & CRC Beginner Program

Course #: BI13243
October 3 - December 12, 2018 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings. No Class November 21.

$1,795.50

Tools for Trainers: Clinical Research Job-Aids and Checklists

Course #: BI13244
October 4, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Course #: BI13232
October 9, 2018 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

30-Hour Clinical Project Management Fundamentals Certification Program

Course #: BI13245
October 12 - December 21, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Friday Afternoons. No class November  23.

$1,795.50

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

Course #: BI13246
October 16, 2018 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

Introduction to Data Management

Course #: BI13247
October 17, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13538
October 19, 2018 - January 25, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Friday Mornings. No Class 11/2, 11/23, 12/14, 12/28, 1/4.


Take advantage of our $1615.50 price by registering early!
* After Friday, September 28, 2018, costs are $1795.50.
$1,615.50

Protocol Deviations: Documenting, Managing, and Reporting

Course #: BI13248
October 18, 2018 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately

Course #: BI13249
October 18, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$562.50

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

Course #: BI13250
October 22, 2018 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

NEW! Strategies for Active Listening

Course #: BI13358
October 23, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management

Course #: BI13251
October 24, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Data Quality in Clinical Trials: Rationale and Impact

Course #: BI13252
October 24, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

NEW! Coaching Skills for Leaders

Course #: BI13359
October 25, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

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

Course #: BI13253
October 29, 2018 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

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

Course #: BI13254
October 29, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

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

Course #: BI13255
October 29, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13537
October 29, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Monitoring Plan Development

Course #: BI13256
October 30, 2018 | Interactive Web Seminar
8:30 AM - 10:30 AM Eastern
$661.50

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

Course #: BI13257
October 30, 2018 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Risk-Based Auditing: Effective Compliance Strategies

Course #: BI13258
October 30, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate?

Course #: BI13259
October 30, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Course #: BI13260
October 31, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Case Report Form Design, Strategy, and Standards

Course #: BI13261
October 31, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Understanding the FDA/OHRP Joint Guidance on Minutes of IRB Meetings

Course #: BI13262
October 31, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

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

Course #: BI13263
November 1, 2018 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

CAP and CLIA Requirements for Clinical Research Laboratories

Course #: BI13265
November 1, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Informed Consent Procedure: Lessons Learned from Inspection Findings

Course #: BI13264
November 1, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

Course #: BI13266
November 1, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13267
November 2, 2018 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Centralized TMF Management: The CRO Sponsor Partnership

Course #: BI13268
November 2, 2018 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Good Clinical Practice: Practical Application and Implementation

Course #: BI13269
November 2, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

eTMF Implementation Strategies

Course #: BI13270
November 2, 2018 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$751.50

The Fundamentals of Clinical Research Project Management

Course #: BI13271
November 5, 2018 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Strategies for Building High-Performing Clinical Research Teams

Course #: BI13272
November 5, 2018 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Current FDA and EMA Inspection Findings: Lessons Learned

Course #: BI13273
November 6, 2018 | Interactive Web Seminar
1:00 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.

$661.50

Monitoring Oncology Clinical Trials

Course #: BI13274
November 7, 2018 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Data Management Plan Creation: Content and Rationale

Course #: BI13275
November 7, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Cases in Advanced GCP: A Problem-Solving Practicum

Course #: BI13276
November 8, 2018 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Ensuring Success Through Smarter Site Selection and Study Feasibility

Course #: BI13277
November 8, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Negotiation Skills for Clinical Research Professionals

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

Root Cause Analysis: Applying the Concept for Better Study Compliance Management

Course #: BI13279
November 12, 2018 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

Course #: BI13280
November 12, 2018 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$751.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13281
November 13, 2018 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Preparation, Management, and Response to Inspections and Audits

Course #: BI13282
November 13, 2018 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$940.50

Use of Notes to File in Clinical Trial Essential Documentation

Course #: BI13283
November 13, 2018 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$751.50

Understanding Clinical Laboratory Regulatory Requirements

Course #: BI13284
November 13, 2018 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Monitoring Medical Device Trials: An Introduction

Course #: BI13285
November 13, 2018 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Regulatory Intelligence

Course #: BI13287
November 14, 2018 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

FDA Drug Approval Process

Course #: BI13286
November 14, 2018 | Interactive Web Seminar
12:30 PM - 3:30 PM Eastern
$661.50

eSource and Mobile Technology Initiatives: Data Management Considerations

Course #: BI13288
November 14, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Sponsor Management of Investigator Non-Compliance

Course #: BI13289
November 16, 2018 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Leading Teams in a Changing Clinical Research Environment

Course #: BI13290
November 16, 2018 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$661.50

Strategies to Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance

Course #: BI13291
November 19, 2018 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

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

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

EARLY REGISTRATION
Course #: BI13365
November 19, 2018 - February 11, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class December 24, December 31, January 7.


Take advantage of our $1615.50 price by registering early!
* After Friday, October 19, 2018, costs are $1795.50.
$1,615.50

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

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

Take advantage of our $765.000 price by registering early!
* After Friday, October 26, 2018, costs are $945.000.
$765.00

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

EARLY REGISTRATION
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.


Take advantage of our $1615.50 price by registering early!
* After Friday, October 26, 2018, costs are $1795.50.
$1,615.50

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

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

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

Take advantage of our $765.000 price by registering early!
* After Friday, November 2, 2018, costs are $945.000.
$765.00

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

NEW! Strategies for Having Difficult Conversations

Course #: BI13360
December 6, 2018 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

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

EARLY REGISTRATION
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.


Take advantage of our $1615.50 price by registering early!
* After Friday, November 9, 2018, costs are $1795.50.
$1,615.50

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

EARLY REGISTRATION
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.


Take advantage of our $1615.50 price by registering early!
* After Friday, November 9, 2018, costs are $1795.50.
$1,615.50

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

EARLY REGISTRATION
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..


Take advantage of our $1615.50 price by registering early!
* After Friday, November 9, 2018, costs are $1795.50.
$1,615.50

TMF/eTMF Audit Strategies

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