--- title: "SimpleTrials CTMS/eTMF Software Pricing, Alternatives & More 2026 | Capterra" description: "With the help of Capterra, learn about SimpleTrials CTMS/eTMF Software - reviews, pricing plans, popular comparisons to other Clinical Trial Management products and more." source_url: "https://www.capterra.com/p/112448/Simple-Trial/" page_type: "product" language: "en" --- # SimpleTrials CTMS/eTMF Software Review 2026: Features, Reviews, Integrations, Pros & Cons Last updated on August 19, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Description](#description)[Use cases](#use-cases)[Alternatives](#alternatives)[FAQs](#faqs)[Features](#features)[Pricing](#pricing)[Integrations](#integrations)[Support](#support)[Reviews](#reviews) SimpleTrials CTMS/eTMF ## What is SimpleTrials CTMS/eTMF? SimpleTrials CTMS and eTMF: Streamlined, Affordable, and Integrated Clinical Trial Management SimpleTrials is a cloud-based Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solution supporting sponsors, CROs, and sites with affordable, transparent, and scalable tools. Built by clinical trial experts, SimpleTrials offers robust features in an intuitive platform from startup to closeout. Key Features: Study & Site Management: Centralize study data, track site activation, and manage documents. Subject Tracking: Automate enrollment and visit tracking. Financials & Forecasting: Build budgets, reconcile payments, and forecast costs. Key Risk Indicators (KRIs): Monitor study health with built-in risk management. eTMF: Store and organize documents aligned with DIA TMF Reference Model. EDC Integration: Connect with leading EDC systems for seamless data flow. Why SimpleTrials? Transparent pricing Easy-to-use interface Compliance with 21 CFR Part 11, GDP ## What is SimpleTrials CTMS/eTMF used for? [Clinical Trial Management](https://www.capterra.com/clinical-trial-management-software/)[Document Management](https://www.capterra.com/document-management-software/) Top alternative Featured Overall rating Based on 4 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price $599 Usage Based, Per Month Free trial available Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... Do you work for SimpleTrials CTMS/eTMF?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=http://www.simpletrials.com&name=SimpleTrials CTMS/eTMF) ## Compare with a popular alternative Capterra selects software alternatives based on relevant features, verified user reviews and user interactions. Placement may be influenced by client status. ### SimpleTrials CTMS/eTMF 4.8 (4) VS. [4.5 (83)](https://www.capterra.com/p/200364/Florence-eBinders/reviews/) Starting Price $599 Usage Based, Per Month Starting Price Contact vendor Free Trial Free Version Pricing Options Free Trial Free Version Ease Of Use 4.5 (4) Ease Of Use 4.2 (83) Value For Money 4.7 (3) Value For Money 4.5 (50) Customer Service 5.0 (3) Customer Service 4.6 (65) ## SimpleTrials CTMS/eTMF alternatives [4.8 (44)](https://www.capterra.com/p/253399/ShareCRF/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 100% of reviewers rated it above 4 stars [4.7 (204)](https://www.capterra.com/p/143532/Castor-EDC/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 98% of reviewers rated it above 4 stars [4.2 (118)](https://www.capterra.com/p/192454/Research-Manager/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 86% of reviewers rated it above 4 stars Highest Rated [4.9 (66)](https://www.capterra.com/p/126679/RealTime-CTMS/reviews/) Starting price $500.00 Per User, Per Month Pricing Options Free Trial Free Version User Rating 100% of reviewers rated it above 4 stars ## FAQs about SimpleTrials CTMS/eTMF Overview ### What company size and specific industries is SimpleTrials CTMS/eTMF built for? SimpleTrials CTMS/eTMF is designed for clinical-stage drug development sponsors, clinical research organizations, biotechnology companies, pharmaceutical companies, and medical device companies involved in clinical development. The product fits organizations managing clinical trials and development programs across the life sciences sector. Features and Usability ### What are the key features of SimpleTrials CTMS/eTMF? SimpleTrials CTMS/eTMF offers clinical study management, document management, and workflow management for trial operations. It also includes 21 CFR Part 11 compliance, audit trail, electronic signature, role-based permissions, customizable templates, reporting and statistics, and document review with version control, archiving and retention, and real-time monitoring. Talk to an expert ### More questions? Ask our experts Integrations ### Which third-party tools and platforms does SimpleTrials CTMS/eTMF integrate with? SimpleTrials CTMS/eTMF integrates with clinical data and trial management platforms including Alcedis Platforms, Castor EDC, ClinCapture, DFdiscover, Datatrak Enterprise Cloud Platform, Ennov EDC, Medidata CTMS, Medrio, OpenClinica, RedCap, TrialKit, Veeva Vault Clinical Operations Suite, Viedoc, Zelta, and iMednet. Getting Started and Support ### What training and onboarding options does SimpleTrials CTMS/eTMF offer? SimpleTrials CTMS/eTMF provides live online sessions, webinars, documentation, and videos to help teams get started. Live online sessions and webinars support guided instruction, while documentation and videos offer self-paced reference and walkthrough materials for learning features and setup steps. Getting Started and Support ### What customer support options does SimpleTrials CTMS/eTMF offer? SimpleTrials CTMS/eTMF provides Email/Help Desk, FAQ/Forum, and Knowledge Base support. These channels give users a way to submit questions, check common answers, and search documentation. No reviewer feedback on support experience is available, so support quality, response speed, and helpfulness cannot be assessed from user comments. ## Features AI summary Based on 349 Clinical Trial Management reviews Capterra reviewers highlight these as the features buyers value most when choosing Clinical Trial Management software: - **21 CFR Part 11 Compliance** (**72%** of reviewers rated this feature as critical) - **Audit Trail** (**52%**) - **HIPAA Compliant** (**76%**) SimpleTrials CTMS/eTMF supports **21 CFR Part 11 Compliance** and **Audit Trail**, giving research teams the controls needed to manage regulated processes and maintain clear records of system activity. However, it does not offer **HIPAA Compliant**. Instead, it provides other important capabilities that reviewers also prioritize, including **Clinical Study Management** (**47%**) and **Document Management** (**54%**), which help businesses organize trial operations and keep essential study files in one place, allowing teams to improve oversight and maintain more consistent documentation. 21 CFR Part 11 Compliance 5.0 (3) 33.33% of 3 reviewers that rated this feature as important or highly important Shows that electronic documents are authentic and linked to specific records Clinical Study Management 4.3 (3) 66.67% of 3 reviewers that rated this feature as important or highly important Tools to manage single or multiple clinical studies within a centralized platform Document Management 4.0 (3) 100.00% of 3 reviewers that rated this feature as important or highly important Store, manage, and track all electronic documents in a centralized location Workflow Management 4.0 (3) 0.00% of 3 reviewers that rated this feature as important or highly important Create, design and manage workflows for repetitive tasks Patient Monitoring 4.5 (2) 50.00% of 2 reviewers that rated this feature as important or highly important Observing and tracking a patient's health status, condition, and wellbeing Scheduling 5.0 (2) 0.00% of 2 reviewers that rated this feature as important or highly important Plan availability and assign specific time slots for tasks and resources SimpleTrials CTMS/eTMF 53 features ### All Features - 21 CFR Part 11 Compliance: Shows that electronic documents are authentic and linked to specific records - Access Controls/Permissions: Define levels of authorization for access to specific files or systems - Activity Dashboard: Dashboard to view the status of ongoing processes, identify current incidents and track past activities - Activity Tracking: Track and document all activities across devices, networks, and other systems - Ad hoc Reporting: Generate one-off reports that meet information requirements - Alerts/Notifications: Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges - API: Application programming interface that allows for integration with other systems/databases - Approval Process Control: Manage the process of evaluating documents or requests submitted for approval - Archiving & Retention: Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes - Audit Trail: A record of all activities within the system, including user access, changes made, etc. - Calendar Management: Track and manage schedules and meetings via an integrated calendar - Clinical Study Management: Tools to manage single or multiple clinical studies within a centralized platform - Collaboration Tools: Provides a channel for team members to share AI models, media files, communicate, and work together - Commenting/Notes: Leave comments and notes on documents for others to view - Compliance Management: Track and manage adherence to policies for any service, product, process, or supplier - Compliance Tracking: Track and report regulatory data to either internal management or external stakeholders - Content Management: Handles digital content throughout its lifecycle, from creation and storage to distribution and archiving - Customizable Branding: Add customized logos and colors to align with company branding - Customizable Reports: Alter the layout and content of reports - Customizable Templates: Pre-designed layouts that can be customized to match preferences and requirements - Data Import/Export: Import and export data to and from software applications - Data Visualization: Graphical representation of data - Digital Signature: Electronic signing method that validates the authenticity and integrity of a digital document - Document Capture: Scan, move or upload electronic files within the software's repository - Document Classification: Assign categories, labels, tags, or attributes to documents for organization, search and storage - Document Management: Store, manage, and track all electronic documents in a centralized location - Document Review: Review and analyze existing information across documents - Document Storage: Store and organize documents in a centralized system - Drag & Drop: Assemble applications and processes by dragging over and arranging pre-built components - Electronic Signature: Digitally sign online documents - Enrollments/Onboarding: Manage the enrollment and onboarding of all new members and accepted applications - File Recovery: Recover lost, deleted, or damaged files - Financial Management: Plan, manage, and track the financial activities of an individual or organization - Full Text Search: Search for specific words or phrases within a document or database - Metadata Extraction: Retrieval of embedded metadata that is present within a file - Monitoring: Observe and track the demand, usage, progress or quality of a system, product, or user - Patient Monitoring: Observing and tracking a patient's health status, condition, and wellbeing - Progress Tracking: Reporting on how each user, task or process has advanced since its initiation - Real-Time Data: Receive data and information in real time - Real-Time Monitoring: Active monitoring of systems, applications, or networks - Real-Time Reporting: Active reporting of data and metrics - Reminders: Timed notification for any upcoming task, deadline, appointment, or activity - Reporting & Statistics: Collection, analysis, and representation of numerical data and generation of reports to understand various patterns - Role-Based Permissions: Set & manage permission levels based on user roles and restrict access to only authorized individuals - Scheduling: Plan availability and assign specific time slots for tasks and resources - Search/Filter: Search and filter data across systems to locate required information by entering keywords or certain criteria - Secure Data Storage: Securely stores data to prevent data loss or breaches - Tagging: Attach digital tags to documents and assets for identification, search, or monitoring purposes - Task Management: Create, manage and track all task activities and progression - Third-Party Integrations: Set up connections to third-party platforms to improve business processes - User Management: Manage user accounts, profiles, roles, permissions, and other details across applications, devices or networks - Version Control: Track revisions and updates made to files and navigate between different versions - Workflow Management: Create, design and manage workflows for repetitive tasks --- Get Advice We can help you find the software with the features you need. Features 4.5 (4) 4.5 Based on 4 reviews ## Pricing Value for money 4.7 (3) Free Trial Basic $599.00 Usage Based,Per Month Value for money 4.7 (3) 4.7 Based on 3 reviews ## Integrations [ Castor EDC](https://www.capterra.com/p/143532/Castor-EDC/)[ Viedoc](https://www.capterra.com/p/160680/Viedoc/)[ Medrio](https://www.capterra.com/p/92497/Medrio/)[ OpenClinica](https://www.capterra.com/p/78122/OpenClinica/)[ TrialKit](https://www.capterra.com/p/149821/Clinical-Studio/)[ RedCap](https://www.capterra.com/p/234600/RedCap/)[ ClinCapture](https://www.capterra.com/p/133931/ClinCapture/)[ Medidata CTMS](https://www.capterra.com/p/84472/Medidata-CTMS/) Connect with a Capterra advisor for a free 15-minute consultation Get a personalized software list aligned to your business needs with guidance from our expert advisors. Our team has helped 1 million+ businesses like yours find options that fit their needs. ## Support, customer service and training options Customer Service 5.0 (3) Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises Customer Service 5.0 (3) 5.0 Based on 3 reviews ## User reviews Overall rating 4.8 Based on 4 reviews Filter by rating 5(3) 4(1) 3(0) 2(0) 1(0) Mentioned topic Sorted by most recent NS Nathanial S. Medical Director Health, Wellness and Fitness ### "Trial of Simple Trials" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 0.0 0.0 Likelihood to Recommend 7/10 August 20, 2023 Pros We found the integration of simple trials into our organisation seamless, and we've been very happy so far Cons The price point for a small business is always something that can be improved on Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. TS Teresa S. Systems Operations Manager Research ### "Great option for Mid-Size CRO " 5.0 Overall Rating 5.0 5.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 9/10 March 17, 2022 Support is very responsive and helpful! As with many CTMSs, the ability to use the system to its full benefit requires a good deal of resource specifically for set up. However, once correctly set up, the process is simple. Pros SimpleTrials functionality is great for tracking general study metrics. The graphic dashboards are useful for high-level overviews. Various default CTMS reports also allow for easy review of data. Cons The filter functions on the CTMS reports and how they relate to the various column options are not particularly intuitive to the casual user. Limitations on number of templates and letters is also frustrating. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. SC Silvia C. CEO Hospital & Health Care ### "Good system to have an overview of the company project. Easy to set up and easy to use." 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 8/10 September 30, 2021 SimpleTrials allows us to have a good overview of the company projects and to significatly reduce the need for manual tracking. Pros It is easy to use and all steps are done quickly (is an agile tool) Cons The flexibility is limited, some changes / updates are not possible and eTMF customization is a bit complex, though the client support team is very good. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. KM Krishna M. Clinical Trial Assistant Medical Devices ### "Excellent Clinical Trial Management System with Extraordinary Customer Service" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 June 10, 2020 I had an excellent experience with using SimpleTrials & would highly recommend them to other vendors for study & portfolio management. They have outstanding customer service! Pros SimpleTrials facilitates easy online access for me to upload & view essential study documents online. The workspace is super easy to maneuver around. I love everything about this software as it thoroughly assists me with study and portfolio management . I am also extremely impressed with their customer service because they respond promptly, answer all your questions, and offer useful and practical solutions. Their customer support went out of their way to assist me in a technical issue I was experiencing. Cons I am pretty new to using the SimpleTrials software, and so far, I don't see any cons associated with it. I think it is very well-designed and easy to use. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. ## Top-rated software of 2026 ### Fill out the form and we'll send a list of the top-rated software based on real user reviews directly to your inbox.