The Clinical Trial Risk Tool is a browser-based tool which uses Natural Language Processing (NLP) to analyse clinical trial protocols. We are pleased to announce the publication of a technical paper on the tool.
A BibTex citation is as follows:
@article{wood2023clinical,
title={Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness},
author={Wood, Thomas A and McNair, Douglas},
journal={Gates Open Research},
volume={7},
number={56},
pages={56},
year={2023},
publisher={F1000 Research Limited}
}
A number of documents are needed to produce a complete and accurate clinical trial budget. The necessary documents typically include: the study protocol (generally the most important document for building a budget) the informed consent form the clinical trial agreement or sponsor contract any laboratory and pharmacy manuals the charge master or schedule of fees the sponsor’s budget. However, sometimes a sponsor will send only the synopsis to a CRO when requesting a quote.
Are you wondering how you can build a detailed clinical trial budget from the protocol, whether for a site, CRO, or sponsor? This may appear an intimidating task. You have to read the protocol carefully, find the schedule of events, calculate how many times each activity occurs during the trial, and slowly create an itemised budget spreadsheet. There are cost items buried in footnotes that you need to look for.
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician In 2025, the outsourcing of clinical trials has become a common strategy for pharmaceutical and biotechnology sponsors. Facing rising R&D costs and complicated studies, sponsors turn to Contract Research Organizations (CROs) and other external partners to manage clinical trials. This practice, known as outsourcing clinical trials, is adopted as a best practice for containing costs and enhancing efficiency in drug development [1].