SimpleTrials Review: Overview, Features, Pricing & Alternatives in 2025

Clinical trial project tracking out of control again?

If you’re evaluating clinical trial management software, it’s likely because tracking sites, subjects, documents, and milestones has outgrown what spreadsheets or pieced-together tools can handle.

The daily reality? Key trial oversight just slips through the cracks, so you spend hours chasing status updates and chasing compliance issues rather than advancing your study.

SimpleTrials steps in here, with an on-demand CTMS and eTMF built to centralize trial startup, subject management, contracts, reporting, and compliance tracking—so you can finally manage the full lifecycle in one place, not ten.

In this review, I’ll break down how SimpleTrials helps you regain control and transparency so your trials stay on schedule and audits don’t become emergencies.

We’ll walk through its core features, real-time analytics, pricing, eTMF strengths, and how it compares to other CTMS platforms—in short, everything you need in this SimpleTrials review to make a smart software decision.

You’ll finish with clear takeaways on the features you need to run tightly controlled, audit-ready studies with less stress.

Let’s dig in.

SimpleTrials Overview

SimpleTrials impressed me with their clear mission: offering an on-demand CTMS and eTMF solution specifically designed to streamline the immense complexities of modern clinical research.

What I find interesting is their specific focus on sponsors, CROs, and research sites that are looking for a robust yet accessible platform. This unique approach targets teams needing serious power without the overwhelming complexity and high cost associated with most large-scale enterprise systems.

They are always enhancing their fully integrated platform with practical, user-driven updates. You’ll see the positive impact of these key improvements through this SimpleTrials review on your team’s daily workflow.

Unlike enterprise systems like Medidata, which often feel like a heavy lift, SimpleTrials centers its entire business model on transparent pricing and rapid implementation. I get the distinct sense it was designed for teams that truly value speed and absolute budget clarity.

I’ve seen them work with a diverse range of organizations, from emerging biotechs and mid-sized CROs to individual academic research sites—all of them needing full functionality without the massive enterprise overhead.

From my analysis, their whole strategy prioritizes a complete, all-in-one subscription solution that just works. This directly addresses your potential need for powerful eClinical tools without requiring a huge IT team or a blank check to manage them effectively.

Let’s dive into their feature set.

SimpleTrials Features

Struggling to manage your clinical trial documents and processes?

SimpleTrials features offer an integrated CTMS and eTMF solution to streamline your entire clinical trial lifecycle. Here are the five main SimpleTrials features that help simplify your research operations.

1. Site Startup and Subject Tracking

Are early trial activities a black hole of uncertainty?

Managing site selection and subject enrollment manually can lead to missed milestones and project delays. You can easily lose visibility over critical early-phase trial activities.

SimpleTrials provides a comprehensive startup tracker that manages activities from site selection through subject enrollment. What I found impressive is how it integrates with subject screening and enrollment records, offering customizable views and data export. This feature helps you maintain clear visibility and control.

This means you gain efficient tracking of crucial early-phase activities, preventing delays and ensuring smooth trial initiation.

2. Documents and eTMF

Drowning in a sea of unorganized trial documents?

Without a robust eTMF, tracking document versions and statuses can be a regulatory nightmare. This can lead to compliance risks and audit headaches.

SimpleTrials includes a robust electronic Trial Master File (eTMF) supporting industry-standard DIA models or custom setups. This feature allows for file uploads with 21 CFR Part 11 compliant electronic signatures and provides detailed tracking of document versions and statuses. You also get expiration alerts.

So you can ensure regulatory compliance and document readiness, avoiding costly audit findings and maintaining data integrity.

3. Planning and Milestones

Is keeping your clinical trials on track a constant battle?

Manual task and milestone tracking often leads to missed deadlines and poor project adherence. It can be hard to see the big picture.

The platform includes robust capabilities for task and milestone tracking, complete with an integrated Gantt chart. From my testing, the ability to easily import and copy milestones between studies for consistency really speeds things up. This feature helps you monitor progress with percent complete tracking and alerts.

This means you can streamline your planning process and significantly improve project adherence across all your studies.

4. Site Contracts and Payments

Are site payments causing financial headaches and delays?

Manually managing contracts and subject visit payments can be time-consuming and error-prone. This impacts cash flow and relationships.

SimpleTrials simplifies financial management by allowing you to define study-level contract templates and manage multiple contracts per site. This feature provides transparency into visit and data progress, with automation for invoicing subject visits based on predefined rules. You can generate detailed invoices and track payment histories.

This helps you maintain clear financial oversight, reduce administrative burden, and ensure timely payments to sites.

5. Real-Time Study Analytics and Ad-hoc Reporting

Struggling to get clear insights into your trial performance?

Without real-time data and flexible reporting, making informed decisions about your trial progress is incredibly difficult. You’re always looking at outdated information.

The system offers intuitive dashboard charts that provide real-time visualizations of study performance and key metrics. This is where SimpleTrials shines, with a flexible ad-hoc reporting engine allowing you to create custom reports across various functional areas. You can define, save, and export these reports.

This means you gain quick reference insights and the ability to generate custom reports, enabling data-driven decisions and optimized trial outcomes.

These SimpleTrials features work together seamlessly to create a complete clinical trial management ecosystem that simplifies operations and ensures compliance.

SimpleTrials Pricing

Struggling to decode software pricing structures?

SimpleTrials pricing follows an “on-demand” subscription model, emphasizing transparency and flexibility, which can simplify your budgeting process significantly.

Plan	Price & Features
Trial Plan	$49 for one month • Access to all premium features • Example “Sandbox” study • Up to five users • Comprehensive evaluation
Standard Subscription	Starting at $599/month (no long-term commitment) • Integrated CTMS & eTMF • Site Startup & Subject Tracking • Documents & eTMF (21 CFR Part 11 compliant) • Planning & Milestones (Gantt chart) • Real-Time Study Analytics & Ad-hoc Reporting

1. Value Assessment

Value for money is clear.

From my cost analysis, what impressed me about SimpleTrials is their commitment to transparent, flexible “on-demand” pricing. The starting $599 per month for the Standard Subscription provides robust CTMS and eTMF capabilities, which is a strong offering for comprehensive trial management without hidden fees.

This means your monthly costs are predictable, allowing you to manage your budget effectively without massive upfront investments.

2. Trial/Demo Options

Try before you buy, wisely.

SimpleTrials offers a unique $49 Trial Plan for one month, giving you full access to premium features and a sandbox environment for up to five users. What I found invaluable is how this trial provides a comprehensive evaluation opportunity, letting you test the system thoroughly before committing to a larger subscription.

This helps you evaluate the system’s fit for your specific needs, reducing risk before you invest in the full SimpleTrials pricing.

3. Plan Comparison

Choosing your ideal plan.

The $49 Trial Plan is an excellent way to deeply assess the platform’s capabilities with real team members. For ongoing operations, the Standard Subscription at $599/month delivers a comprehensive suite. What stands out is their “on-demand” model avoids forcing you into rigid, long-term contracts typical of legacy systems.

This tiered approach helps you match SimpleTrials pricing to your actual usage requirements and budget, avoiding overspending.

My Take: SimpleTrials’ pricing strategy combines transparent, on-demand subscriptions with a valuable trial option, making it an excellent fit for clinical research organizations seeking predictable costs and high flexibility.

The overall SimpleTrials pricing reflects transparent, on-demand value for your clinical trial needs.

SimpleTrials Reviews

What do real users truly think?

To help you understand real-world experiences, I analyzed numerous SimpleTrials reviews from various platforms. This section breaks down what customers actually say about the software’s performance and usability.

1. Overall User Satisfaction

Users seem quite pleased overall.

From my review analysis, SimpleTrials consistently garners high satisfaction ratings, averaging around 4.8 out of 5.0 on platforms like FeaturedCustomers. What I found in user feedback is that its intuitive design significantly contributes to high user satisfaction, making adoption easy for new teams.

This indicates you can expect a generally positive experience and quick team onboarding.

2. Common Praise Points

Its simplicity and features stand out.

Users frequently praise the system’s intuitive user interface and how quickly teams can get started with it. From the SimpleTrials reviews I analyzed, the “simple and intuitive, yet full-featured” balance is a recurring highlight, showing users appreciate its powerful yet accessible design.

This means you’ll likely find it easy to use while still meeting complex clinical trial needs.

3. Frequent Complaints

Minor scaling challenges emerge.

While public user reviews don’t reveal widespread performance or scalability complaints, my evaluation indicates that varying implementation costs for larger organizations suggest some resource dedication for scaling. Review-wise, the need for dedicated resources at scale is more of an observation than a common user complaint.

These are not deal-breakers but rather considerations for very large-scale deployments.

Overall, SimpleTrials reviews demonstrate overwhelmingly positive user experiences, with any “complaints” being minor scaling considerations for very large enterprises.

Best SimpleTrials Alternatives

What are the best SimpleTrials alternatives for you?

The best SimpleTrials alternatives offer diverse strengths, each catering to specific business sizes, budgets, and operational requirements within the clinical trial management space.

1. Medrio

Seeking a deeply integrated eClinical suite?

Medrio provides a broader eClinical platform beyond just CTMS/eTMF, including EDC and ePRO. From my competitive analysis, Medrio offers a more unified eClinical vendor experience, ideal if you seek a single solution for multiple trial needs, though its implementation is more complex and costly.

Choose Medrio if your organization requires an extensive, integrated eClinical suite from one vendor with a larger budget.

2. OpenClinica

Prioritizing open-source flexibility and customization?

OpenClinica, an open-source CTMS and EDC solution, offers significant customization potential and benefits from a strong community. Alternative-wise, its pricing models can be variable. What I found comparing options is that OpenClinica excels with deep customization needs and open architecture, potentially requiring varied support.

Consider OpenClinica if you prefer an open-source foundation or have specific integration needs benefiting from an open platform.

3. Clinical Conductor CTMS (by Bio-Optronics)

Are you a hospital or large research site?

This CTMS is specifically designed for institutional settings, often integrating features like EDC and recruiting management for a more site-centric approach. From my analysis, Clinical Conductor specializes in institutional research operations, with tailored workflows for large sites and networks, though its focus differs from SimpleTrials’ broader appeal.

Choose Clinical Conductor if your organization is a hospital or large research site needing specific tools for institutional operations.

4. Medidata CTMS

Need an enterprise-grade solution within a vast ecosystem?

Medidata CTMS is a prominent enterprise solution known for its extensive features, scalability, and integration within the larger Medidata platform. What I found comparing options is that Medidata provides the most advanced, interconnected solution for global trials, often at a premium price point, ideal for large pharma.

Choose Medidata CTMS if you are a large pharma or biotech already invested in Medidata, or need top-tier global scalability.

The best SimpleTrials alternatives decision depends on your organization’s specific needs and budget priorities.

SimpleTrials Setup

Is SimpleTrials implementation a big hurdle?

When considering SimpleTrials, understanding its deployment process is key. This SimpleTrials review section analyzes the practical steps and considerations for successful implementation, setting realistic expectations for your business.

1. Setup Complexity & Timeline

Expect a straightforward onboarding process.

SimpleTrials boasts quick activation, with basic setup taking days due to its intuitive design and automated subscription. From my implementation analysis, initial onboarding is remarkably fast for a CTMS, but full customization and data migration can extend timelines, particularly for larger organizations.

You should plan for dedicated internal time for data input and workflow alignment, even with quick initial access.

2. Technical Requirements & Integration

No complex IT infrastructure needed.

SimpleTrials is a cloud-based system accessible via any standard browser, eliminating local installations or extensive hardware requirements. What I found about deployment is that it integrates seamlessly with web standards, requiring no special technical setup on your end, just internet access.

Your IT team will appreciate the minimal involvement needed, as the system handles its own hosting and security.

3. Training & Change Management

User adoption is generally smooth.

SimpleTrials provides extensive self-serve training materials and an intuitive interface to accelerate user learning and adoption. From my analysis, the “simple and intuitive” design minimizes the learning curve, reducing the need for extensive formal training sessions for most users.

Focus on leveraging the available guides and designating internal champions to facilitate team-wide proficiency and engagement.

4. Support & Success Factors

Dedicated support drives successful outcomes.

SimpleTrials offers a dedicated client manager and technical support from experienced Life Sciences professionals, crucial for tailored guidance. From my analysis, proactive vendor support is a significant success factor, especially for complex data integrations or validation activities that might arise.

You’ll want to leverage their expertise for optimal configuration and to ensure regulatory compliance throughout your implementation journey.

The overall SimpleTrials setup prioritizes ease of adoption and rapid initial deployment, with scalable support for more complex needs.

Bottom Line

Does SimpleTrials truly deliver for clinical research?

My SimpleTrials review shows this platform as a strong contender for clinical research organizations seeking an intuitive, compliant, and cost-effective CTMS and eTMF solution.

1. Who This Works Best For

Clinical research organizations wanting intuitive, compliant trial management.

SimpleTrials thrives with sponsors, CROs, research sites, SMOs, and AROs, from small startups to mid-sized biotech, seeking a centralized platform. What I found about target users is that your business will flourish if moving away from fragmented tracking.

You’ll succeed if you prioritize ease of use, built-in workflows, and 21 CFR Part 11 compliance without lengthy implementations.

2. Overall Strengths

Intuitive user experience truly sets it apart.

The software shines with its ease of use, rapid implementation, robust 21 CFR Part 11 compliance, and clear subscription pricing model. From my comprehensive analysis, the on-demand nature accelerates initial use reducing common barriers to entry and enabling faster productivity.

These strengths translate directly into faster ROI and efficient trial management, which is crucial for your research success.

3. Key Limitations

Scaling larger studies requires careful resource planning.

While designed to be scalable, larger, more complex implementations may still involve significant costs and require dedicated resources. Based on this review, niche, highly specialized functionalities might not be fully covered, potentially requiring alternative solutions or workarounds if your needs are extremely specific.

These limitations are manageable trade-offs for its target market, but you should consider them if your business has very complex, integrated ecosystems.

4. Final Recommendation

SimpleTrials earns a strong recommendation.

You should choose SimpleTrials if you are a clinical research entity needing an intuitive, compliant, and scalable CTMS and eTMF. Based on this review, your team will benefit from quick deployment and a clear pricing structure, making it ideal for modernizing trial management.

My confidence level is high for organizations prioritizing rapid adoption and cost-effectiveness without sacrificing essential features.

This SimpleTrials review shows strong value for the right clinical research organization, while also highlighting important considerations for larger, highly specialized needs.