TransCelerate Releases RBM Pilot Update - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
TransCelerate Releases RBM Pilot Update

Source: Applied Clinical Trials

Risk Based Monitoring Special Section

Risk-Based Monitoring Conference SPOTLIGHT EVENT
Risk-Based Monitoring –
Beyond Theory In-Depth Review

March 13, 2014
Cambridge, Massachusetts

Download Brochure
Register

RELATED
- The Emergence of the Centralized Monitor
- Risk-Based Approaches
- ICON Exec Discusses ICONIK Monitoring
More in Risk-Based Monitoring

TransCelerate BioPharma has provided the first update to its position paper on risk-based site monitoring, released last June. The update is a result of continued refinement of the position paper's concepts and assessing the experiences and lessons learned by the TransCelerate member companies that piloted the RBM methodology.

"Through piloting TransCelerate's RBM methodology, framework and tools, we have sought to manage clinical trial risks through identification, categorization and appropriate mitigation," said Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate. "We have learned important lessons from our member companies and regulatory agencies on tools like the RACT (Risk Assessment and Categorization Tool), which will help companies identify and plan their risk mitigation strategies, and a focus group has been tasked with assessing the feedback and implementing changes to the tool. We also have received valuable feedback on our pilot study monitoring plans."

You can read the full release here.

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
7%
View Results
Untitled Document
Source: Applied Clinical Trials,
Click here