Events

Clinical Trials Abroad: Asia

SCDM Webinar Series

Webinar #1: Blended resourcing models for global organizations
Webinar #2: East meets West: - Working effectively with colleagues in different countries and time zones

Course Description:

The recent announcement that the FDA plans to open permanent offices in China demonstrates the growing importance of global drug and medical device development in Asian countries. This webinar will address the critical factors in successfully creating and maintaining a global organization. Examples will illustrate blended resourcing models that result from R&D expansion, company expansion, and outsourcing models and relationships. Presenters will address project startup, data flow and data quality, as well as how to communicate effectively with colleagues in different countries. Rewards, risks and the impact on the future of CDM will also be discussed.

Receive .2 CEUs Per Webinar*

*SCDM is authorized by IACET to offer CEUs for this program. Assessment and post evaluation submissions are required.

CEUs available: .2 CEUs for each webinar, pending successful completion of assessments. 1 contact hour = .1 CEU

Target Audience:

Webinar #1 specifically directed to Management level CDMs and
Webinar #2 directed to a study support audience and those seeking advancement.

And remember, this Series has been pre-approved by SCDM as eligible for up to .4 CEUs towards participant's CCDM® recertification upon successful completion of the assessments.

Objectives:

Attendees will be able to explain how the opportunities for business operations and relationships in Asia may impact current business models.
Attendees will be able to apply knowledge of cycles and trends concerning the movement of R&D and clinical trials in Asia when evaluating organizational and departmental goals and initiatives.
Attendees will be able to list two advantages of working with a CRO (vs. BPO company) in a CDM outsourcing arrangement.
Attendees will be able to list two advantages of working with a BPO company (vs. CRO) in a CDM outsourcing arrangement.
Attendees will be able to list three different sponsor/provider relationship models which they would consider in a potential outsourcing arrangement.
Explain the salient communication issues to address when conducting clinical trials abroad.
Describe three advantages and three challenges to conducting clinical trials abroad.
Apply the information to improve relationship management for offshore clinical trials.

Presenters:

John Haley
John Haley worked for approximately seventeen years in the field of clinical nutrition providing direct nutritional care to people with psychiatric and developmental disorders. He spent the last twelve and a half years in clinical data management in the CRO and Business Process Outsourcing arena working with pharma and biotech companies. He is currently working on an engagement that utilizes offshoring extensively in clinical data management.

Joshua Cox
Joshua Cox is a Clinical Data Coordinator who has worked in several modalities of clinical data management, primarily on phase II and III studies encompassing Infectious Disease, Allergy and Immunology, Diabetes Mellitus and Oncology. Joshua's most recent role has been in the leadership capacity of the Data Operations Coordinator for a two-year-old global oncology study spanning 21 countries with a target study population of over 800 patients.

Janine Del Vecchio
Janine has worked in the field of Clinical Data Management for over 16 years, mainly in large pharmaceutical companies and recently in the medical device sector. She holds a Bachelor of Arts Degree from Caldwell College (NJ), in Biology and Chemistry and a Master of Science degree in Biology with a Business minor from Seton Hall University (NJ).

Dr. Nimita Limaye, PhD, CCDM
Dr. Nimita Limaye, a Doctorate in Biotechnology from Pune University, is currently working as VP (CDM & Medical Writing) at SIRO Clinpharm Pvt. Ltd., one of India's oldest leading Indian CROs, and is leading a team of about 150 professionals.