|
|
|
| home > white papers > The Role of the CRO in Effective Risk-Based Monitoring - Medpace |
|
|
 WHITE PAPERS |
|
Medpace
|
|
The Role of the CRO in Effective Risk-Based Monitoring
|
|
The clinical trial industry is evolving. In an effort to improve
participant safety and data integrity, regulators are encouraging trial
sponsors to transition from a focused on-site monitoring approach they
have traditionally employed toward a risk-based approach that utilizes a
combination of centralized and on-site monitoring techniques to ensure
patient safety and data quality. The Risk-Based Monitoring (RBM)
paradigm has many potential advantages over established monitoring
practices including enhanced patient safety and data integrity, more
efficient and effective protocol design, reduced costs, and the ability
to strategically adjust oversight in keeping with changes in risk level.
Realizing the potential of RBM requires early planning,
analytical expertise, sophisticated tools and process adaptability. Deep
cross-functional expertise early in the trial process enhances the
ability to assess overall risk, define critical data and processes,
develop an integrated plan for addressing risk, and execute a monitoring
plan that meets the trial’s unique requirements.
|
|
|
|
|
|
|
 |
News and Press Releases |
 |
Business Continuity Plan - Message from Protagen Protein Services (PPS)
Following the recent COVID-19 outbreak, we at Protagen Protein Services (PPS) are preparing for all eventualities. Please be assured that PPS will continue to operate as normal providing you with all of the professional support and service you have to come to expect from us.
Given the gravity of the situation, and to protect our staff, clients, and communities from the spread of the virus, we have taken various measures within a scope of a Business Continuity Plan:
More info >> |
|
 |
White Papers |
 |
|
 |
Industry Events |
 |
World Vaccine Congress Europe
18-21 October 2020, Barcelona, Spain
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >> |
|
|
|
