Your EDC Is Delaying Your Study — OpenClinica

Your EDC is delaying your study.

Slow setup. Sites that won’t adopt. Data rework that pushes your timeline back by weeks. For small to midsize biotech and MedTech teams, the wrong EDC doesn’t just delay your launch — it creates friction at every stage of your study. OpenClinica is built to get out of the way.

2–3 weeks Studies launched
50% Fewer data queries
1,500+ Sponsors, CROs & research sites worldwide
15+ years Avg. customer relationship

Most EDC platforms were built for Pfizer.
You’re not Pfizer.

The average EDC implementation takes 4–6 months. For a 50-person biotech team with a Phase 1 trial on the line, that’s not a minor inconvenience — that’s a competitive disadvantage. Every month of implementation delay is a month your study isn’t enrolling.

OpenClinica was built from the ground up for clinical-stage biotech and MedTech teams who can’t afford that math. Here’s where the delays actually come from — and what we do differently.

Delay 01
Setup and configuration

Enterprise EDC systems take 4–6 months to configure. By the time you’re ready, your protocol has already changed.

OpenClinica: Studies configured in hours. Pre-built CDASH CRF templates, drag-and-drop builder, one-click publishing.
Delay 02
Site adoption

Sites push back on systems that are hard to use. Training takes weeks. Data entry errors pile up.

OpenClinica: An interface sites actually want to use. Guided onboarding, on-demand LMS, 24/5 support included.
Delay 03
Data rework

Edit check failures and query backlogs mean months of cleaning before you can analyze anything.

OpenClinica: Real-time edit checks reduce data queries by up to 50%. Audit trails and validation built in.
Delay 04
Vendor complexity

Five vendors means five integrations, five contracts, and five support queues. Every handoff is a chance for something to slip.

OpenClinica: EDC, eConsent, eCOA, Randomization, EHR-to-EDC, Recruit, and Reporting & Analytics — one platform, one Customer Success Manager, one contract.
Built trust over years. Proven across studies.

After 15 years as a customer, we can confidently say that OpenClinica continues to earn our trust. Their EDC has supported a range of projects for us — pediatric studies, early-phase safety work, later-phase evaluations. What keeps us coming back is their commitment to giving us everything we need and nothing we don’t.

Andreas Habicht
CEO, Signifikans

We’ve enjoyed a very strong relationship with OpenClinica. They are very supportive of our changing needs and this solution provided robust core EDC as a very cost effective option for our growing data management programs. The customer service has been exceptional.

John R.
Senior Director, Clinical Research

Flexible and agile design with robust web services — OpenClinica delivers… The OpenClinica design tools make it easy for non-technical resources to make, test, and then deploy changes while maintaining compatibility with previous iterations.

Leading Clinical Laboratory Services Company
Everything a study needs.
Nothing that slows it down.

OpenClinica is modular — start with EDC and add what you need as your study grows. No forced bundles, no enterprise contract required.

EDC

Build studies in hours with drag-and-drop tools, templated CRFs, and real-time edit checks. 50% fewer data queries. Includes integrated medical coding for adverse events and medications — no third-party tools or audit trail gaps.

eConsent

Multimedia consent experiences with comprehension checks and secure e-signatures. Remote, in-person, or hybrid.

eCOA

Mobile-friendly patient reporting with automated reminders and clean forms that increase compliance.

Randomization

Simple to complex schemes with blinded access, inventory management, and comprehensive audit trails built in.

EHR-to-EDC

Pull lab results, medications, and vitals directly from EHRs. No copy-paste. Fewer transcription errors.

Reporting & Analytics

Real-time visibility into enrollment tracking, query management, and site performance.

All modules connect. Use one or all — they’re built to work together.

See what “low maintenance” actually means in practice.
Featured

Leading Academic Biostatistics Center

A 5-person IT team was maintaining infrastructure for 2 legacy studies. After migrating to OpenClinica, the same team now supports dozens of concurrent studies with 1,000+ participants and 50–60 sites each — with near-zero ongoing IT overhead. Even complex studies with real-time safety monitoring and API integrations run without developer intervention.

“It takes little of my time. The studies are working. Everybody’s happy.”
Three weeks from contract to first patient. Here’s how.
01
Week 1
Study configuration

Your CSM guides you through study setup using drag-and-drop builder and pre-built CDASH templates. No IT dependency. Most teams have a working study by end of week one.

02
Week 2
Site onboarding

Role-based access, guided training via LMS, 24/5 application support. Sites are up and running in days — not weeks. The interface is designed to minimize training time and maximize adoption.

03
Week 3
Go live

One-click study publishing, automated validation environment. First patient ready. Your CSM stays — not a handoff to a ticketing queue. A named person who knows your protocol.

Already mid-study and running into friction? We can help with that too. OpenClinica’s Professional Services team handles mid-study migrations, CRF redesigns, and workflow optimization — without the months-long retainer that enterprise vendors require.
Transparent pricing. No surprises.
No delay getting started.

Pricing is modular — you pay for what you need, not a forced bundle.

Core
EDC + Reporting & Analytics
Serious studies deserve serious tools.
$3,000
/month per study  ·  12-month contract
  • Run multiple studies with volume discounts
  • Dedicated, fully isolated EDC
  • Fully customizable form library
  • Full admin with role-based permissions
  • Vendor audit support with session monitoring
  • Workflows, SMS, and full API access
  • 24/5 helpdesk + dedicated Customer Success Manager (CSM)
  • Full add-on library available
View Full Pricing

Enterprise and multi-year options available for larger programs. Contact us.

Common questions.
Most teams launch their first study in 2–3 weeks. Templated CRFs, onboarding, and a dedicated CSM mean you’re not waiting on IT configuration or months-long validation cycles.
Yes. OpenClinica’s Professional Services team handles mid-study migrations. We’ve done it before and can help you avoid the data integrity and timeline risks that come with a platform change mid-protocol.
No. Start with EDC and add modules — eConsent, eCOA, Randomization, EHR-to-EDC, Recruit — when you’re ready. No forced bundles or enterprise contract required.
21 CFR Part 11, HIPAA, GCP, GDPR, and SOC 2 — built in, not add-ons. Same standards required for regulatory submissions worldwide.
A named Customer Success Manager from day one. Someone who knows your protocol, is reachable when you need them, and stays with you through the life of the study.
The two things we hear most from teams who’ve switched: integrated patient recruitment (no other mid-market EDC has it built in), and pricing that doesn’t surprise you. Happy to walk through a direct comparison for your specific situation.

See how fast your next study could move.

Book a 30-minute demo — we’ll walk through a configured study, show you site onboarding, and give you a realistic picture of what your first three weeks would look like.

Book a Demo

See how fast your next study could move.

We’ll walk through a configured study, show you site onboarding, and give you a realistic picture of what your first three weeks would look like.

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