01/24/2014

CRO Oversight: Risk Assessment & Action Planning

HERE is the LINK to get MORE INFO or to SIGN-UP for the session.

Date: January 28, 2014
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online

This course can also be provided to your team as is or customized at a time convenient for you. Contact me for more info samsather@clinicalpathwaysresearch.com

Course Description: Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process – from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation – requires a high degree of risk-based diligence to satisfy regulators. The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses, monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.

Come to this interactive live session and you will be able to:

Identify the risk-based study management approaches to CRO oversight
Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management
Build a risk-based assessment tool for CRO management Identify key approaches to planning and preparing to outsource

See you there. SAM