Clinical trial protocol software

Clinical trial protocol software

Shining a Light on Clinical Trial Risk: Exploring Clinical Trial Protocol Analysis Software

Clinical trials are the backbone of medical progress, but navigating their design and execution can be complex. Fast Data Science is dedicated to helping researchers by analysing clinical trial protocols through the power of Natural Language Processing (NLP).

We are presenting a selection of software which can be used for clinical trial protocol analysis or clinical trial cost prediction, forecasting, and risk assessment.

1. Clinical Trial Risk Tool by Fast Data Science

Fast Data Science’s Clinical Trial Risk Tool (https://clinicaltrialrisk.org/tool) allows researchers to upload a protocol as a PDF, and it uses an AI model to estimate the risk of the trial ending uninformatively which makes it a go-to clinical trial strategy software for many companies.

The Clinical Trial Risk Tool is free to use for pathologies in an international development context such as HIV and TB, Enteric and diarrheal diseases, Influenza, Neglected tropical diseases, COVID, Malaria, and Polio. For trials in Oncology, Motor neurone disease, Multiple sclerosis, Cystic fibrosis, and other pathologies, it will be available on a subscription basis.

Cost your clinical trial protocol

Estimate trial cost

Upload a clinical trial protocol to the Clinical Trial Risk Tool

You can read more on our website about how the Clinical Trial Risk Tool works. The clinical trial protocol software tool was a winner of the Plotly Dash Apps Challenge and has been published and peer-reviewed in Gates Open Research and featured in the industry publication Clinical Leader.

2. SEPTRE (SPIRIT Electronic Protocol Tool and Resource)

This web-based clinical trial software platform facilitates the creation, management, and registration of high-quality protocols, particularly beneficial for researchers in low-resource settings (access through The Global Health Network: https://edctpknowledgehub.tghn.org/protocol-development/septre-protocol-tool/)

3. Clinical Maestro by Strategikon Pharma

This SaaS platform targets the financial aspects of clinical trials, assisting biopharmaceutical companies, CROs, and service providers with budgeting, proposal development, and vendor management (https://strategikonpharma.com/clinical-maestro-2/)

4. SoftFormance

SoftFormance provides tools for planning, managing, and tracking clinical study data, promoting efficiency and transparency throughout the research process (https://www.softformance.com/industries/software-for-clinical-trials/).

5. Gotrial CLINICA

Gotrial CLINICA is a cloud-based data platform which integrates complex clinical development datasets such as clinical trial data, regulatory approvals, disease or hospital data - amongst others. Find CLINICA at https://www.gotrial.com/#clinica.

6. TrialPro

TrialPro is a free clinical trial software that allows you to import PDF protocols and analyses them on a cloud platform. You can create an account and try the tool for free at https://www.trialpro.ai/.

7. Clinical Trial Participant Financial Burden Calculator

The Clinical Trial Participant Financial Burden Calculator is clinical trial financial management software designed to help potential clinical research participants/ patients better understand and estimate the financial impact and burden of participation. It doesn’t analyse protocols directly like our budgeting and financial modeling software, but you will need to enter the information about the trial manually. Find it at https://trialvalue-burdencalculator.com/.

8. OpentronsAI

OpentronsAI uses an interface powered by Generative AI and LLMs, so that scientists can describe experimental protocols in plain language, and OpentronsAI interprets and generates corresponding automated protocol scripts intelligently. Find it at https://opentrons.com/ai.

8. Shiny CRT Calculator

The Shiny CRT Calculator doesn’t analyse protocols directly but it serves as a tool to calculate power and sample sizes for Cluster Randomised Trials. Find it at https://clusterrcts.shinyapps.io/rshinyapp/.

Other uses of software and AI in clinical trials

A number of software tools exist for clinical trial data management.

Choosing the right tool for your needs

The best clinical trial protocol analysis software for your research depends on your specific goals. Whether it’s risk assessment, or financial and capacity planning, a dedicated tool can significantly streamline your workflow.

Fast Data Science is committed to expanding our NLP capabilities to new disease areas. Stay tuned for future updates as we strive to empower researchers across a wider range of clinical trials!

Further information

How can we create a clinical trial budget from the synopsis?

How can we create a clinical trial budget from the synopsis?

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.

Building clinical trial budgets from the schedule of events: white paper

Building clinical trial budgets from the schedule of events: white paper

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.

Outsourcing clinical trials: the pros and cons in 2026

Outsourcing clinical trials: the pros and cons in 2026

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].