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

PCI Announces Expansion of its Industry-Leading Cold Chain Infrastructure with Dedicated Minus 40 degrees C Facility

Philadelphia, USA – August 29, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, Clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce the completion of a purpose built -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.
More info >>


White Papers

Pharmaceuticals and Healthcare Products

Turkish Cargo

Pharmaceuticals are requiring safe and reliable transportation for being highly temperature sensitive products. Thosepharmaceuticals are; diagnostics, vaccines drugs, sera, plasma, protein clinical trials, biotechnological material, pills and all kind of medicines. Turkish Cargo transports all kind of pharmaceuticals, and has been carrying out its operations of transporting and storing drugs and temperature-sensitive medical supplies successfully and with the experience of 80 years; since 1936.
More info >>


Industry Events

Pharma and Device Packaging and Labelling West Coast 2018

27-28 November 2018, Burlingame, CA

The second edition of the Pharma and Device Packaging and Labeling West Coast was a thought-provoking two days of engaging presentations, discussion and networking.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement