spacer
home > white papers > The Role of the CRO in Effective Risk-Based Monitoring - Medpace
WHITE PAPERS
logo_Medpace.JPG

Medpace

phone +1.513.579.9911
email info@medpace.com
web http://www.medpace.com
email Medpace 5375 Medpace Way, Cincinnati, Ohio, 45227

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.
The Role of the CRO in Effective Risk-Based Monitoring
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Live from Pharmapack: Pharmapack Drug Delivery Index hits record high


More info >>


White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>


Industry Events

The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)

12-13 June 2023, Hilton Geneva Hotel & Conference Centre, Geneva, Switzerland

The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical companies of manufacturing, primary and secondary packaging, purchasing, and supply chain and procurement sectors, CMOs and CDMOs leaders, heads from government and institution on 12-13, June, 2023 in Geneva, Switzerland.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement