spacer
home > ict > summer 2019 > choosing a winning model
PUBLICATIONS
International Clinical Trials

Choosing a Winning Model





How you approach implementing functional service provision (FSP) within your company has a direct effect on how successful those FSP teams will be. A ‘sustainable quality’ approach starts with picking the right model and navigating several areas of focus to ensure its success: planning, training, cultural fit, staff retention, technology, communication, agility, sponsor participation, performance indicators, expectations management, etc.

There are four basic models: uncapped time and materials (T&M), capped T&M, fixed fee, and ring-fenced/ full-time equivalents (FTEs) − each with pros and cons based on trial requirements and real-world experience.

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
About the author


Jo Marshall is the Director of FSP and UK Country Manager for CROS NT. Jo entered the industry as a clinical data manager for Searle and held global data management roles for Pharmacia and Pfizer before moving to a specialist biometrics consultancy and contributing to the growth of that company first as Associate Director, then Managing Director until its sale to CROS NT in 2013. Since being at CROS, she has supported a variety of initiatives including commercial, quality, efficiency, and product development, as well as operational department management for the statistical programming team. She holds an MSc in Clinical Data Management, is the treasurer for the Association for Clinical Data Management (ACDM), and chaired the ACDM conference organising committee for a number of years.


Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

 
Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement