On 8 October, Thomas Wood of Fast Data Science presented the Clinical Trial Risk Tool, along with the Harmony project, at the AI and Deep Learning for Enterprise (AI|DL) meetup sponsored by Daemon. You can now watch the recording of the live stream on AI|DL’s YouTube channel below:
The Clinical Trial Risk Tool leverages natural language processing to identify risk factors in clinical trial protocols. The Clinical Trial Risk Tool is online at https://clinicaltrialrisk.org/tool.
Artificial Intelligence and Deep Learning for Enterprise is a meetup group in London dedicated to talks from people in the industry using developments in AI for exciting real world applications.
We initially developed the Clinical Trial Risk Tool to identify risk factors in HIV and TB protocols. Version 2 is coming soon, which will also make cost predictions (i.e. predict the cost of running a trial in dollars), and which will also cover further disease areas, such as Enteric and diarrheal diseases, Influenza, Motor neurone disease, Multiple sclerosis, Neglected tropical diseases, Oncology, COVID, Cystic fibrosis, Malaria, and Polio.
The project has been funded by the Bill and Melinda Gates Foundation and we have published a technical paper in the journal Gates Open Research:
The software is under MIT License, meaning that it is open source, and can be freely used for other purposes, both commercial and non-commercial, with no restrictions attached. The source code is on Github at https://github.com/fastdatascience/clinical_trial_risk.
[Fast Data Science]](https://fastdatascience.com/) is a leading data science consultancy firm providing bespoke machine learning solutions for businesses of all sizes across the globe, with a concentration on the pharmaceutical and healthcare industries.
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].
