spacer
home > ict > winter 2017 > survey time
PUBLICATIONS
International Clinical Trials

Survey Time

For drug developers, the transition from traditional, 100% source document verification (SDV) to risk-based monitoring (RBM) strategies requires a sweeping transformation in clinical trial operations. RBM impacts everything – from trial design and data management platforms to the roles and skillsets of clinical project teams. Effective change management can identify barriers to implementing RBM, inform the development of training programmes and guide interventions to overcome obstacles among operations teams.

It has been found that incorporating surveys of clinical trial managers (CTMs) and clinical research associates (CRAs) is an effective way to gauge adoption progress and to refine change management processes.

New Mindset

PPD has conducted more than 150 RBM trials since late 2013. Early experience has shown that implementing risk-based approaches necessitates new ways of thinking and executing trials.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
As Executive Director of AIM at PPD, Nicole Stansbury leads the development and implementation of the organisation’s RBM strategy. She holds a Bachelor’s degree in Animal Science from Texas A&M University, US.
spacer
Nicole Stansbury
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
More info >>

White Papers

The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation

BioPharmaSpec

1. Introduction As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

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 >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement