Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle? Or do you work at a sponsor or CRO where you feel sites are making up study budget numbers or are never happy with any budget proposal?
In this article, I’ll share insights on how sponsors and CROs set up overall study budgets and discuss five secrets to getting your dream budget approved.
The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible. Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.
Managing the investigator payment is one of the most challenging aspects of running a clinical trial. Major factors considered by pharmaceutical and biotech companies for investigator payments are therapeutic area of interest, duration of the trial, clinical phase, and patient enrollment.