European Leader in Next-Level, Interactive, Patient-Centric Real-World & Late-Phase Research

Intuitive and easy to use across all age groups, with no patient app needed. Increased patient engagement and adherence thanks to interactive parameter monitoring.

eCOA Workflow for Direct-to-Patient Studies

From the first scan to the last questionnaire, patients take part from home. Your team sees every step in real time.

Patient Cockpit

Give patients visibility into their own study progress. In Climedo's survey of 124 patients, over 50% said they would like a patient cockpit with an overview of their study progress. Patients are willing to share information; sponsors and sites simply need to give them the right platform. Engaging patients at this level helps enroll them faster and reduces drop-out rates over the long term.

Capture Patient Data Remotely With eCOA

Our cloud-based eCOA solution enables you to collect high-quality data for your clinical trial digitally and in a decentralized (remote) way and analyze it in real time.

As an important component of eCOA, ePRO includes all results reported by patients. Electronic data collection simplifies compliance with regulations and traceable audit trails.

What Our
eCOA & ePRO Solutions Do

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Feedback Directly From Patients

ePRO makes clinical trial participation more convenient for patients. For example, on-site appointments become less frequent and patients can easily integrate the maintenance of the electronic patient diary (eDiary, ePRO) into their everyday lives.

This gives you direct feedback from a more diverse group of patients. The simple handling and intuitive use of the tools also lead to higher retention and completion rates.

Improved Data Quality

No more tedious transfer of paper to Excel spreadsheets: This way you avoid errors and save valuable time and money. Data changes are also digitally traceable.

Thus, the traceability of the audit trails required for compliance with the regulations for clinical trials is automatically given when using Climedos ePRO. In addition, mandatory fields, edit checks, input-dependent paths and automatic validations ensure higher data quality.

Extended Data Analysis and Viewing

Patient-reported data is available the moment it is submitted, so patient safety stays in focus throughout data capture and your team can react quickly to (S)AEs.

Saved, pre-filtered views carry over to your next studies, so analysis and future set-ups take less time.

Product Demo

We Offer Different Packages and Prices - Tailored to You and Your Needs.

We'll show you how to start a clinical trial or survey and address your specific needs and desires.

Your Benefits With Climedo

INCREASED PATIENT RETENTION

Patients are motivated to enter their data regularly and on time, thanks to automated reminders.

DEVICE-INDEPENDENT USE

Climedo's ePRO is browser-based, optimized for any common device and immediately usable. There is no need to install an app.

TIME & COST SAVINGS

Thanks to automated processes, administrative tasks are eliminated. This goes hand in hand with a significant reduction of time and costs.

QUALITY AND QUANTITY

Collect more valid data faster through electronic data capture and flexible patient participation.

INTELLIGENT DASHBOARDS

Smart views and individual, clear dashboards enable effortless data analysis.

AUDITED AND VALIDATED

The Climedo system is validated and audited against the relevant EU and US standards and guidelines, such as ICH GCP, GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11, and is HIPAA compliant.

Proven audit experience

No sponsor, CRO or other customer has ever stopped or cancelled an engagement with Climedo due to an audit.

Secure data hosting

Data stored on ISO-certified servers in Frankfurt, with off-site backups, redundant servers and SSL-encrypted data transfer. For EU studies, no data is processed outside the EU; US hosting is possible on request.

All relevant EU/US norms fulfilled

Compliance with:

  • 21 CFR Part 11 (FDA)
  • ISO 9001:2015 (QMS)1
  • EU GMP Annex 11 and EU Regulation 536/2014
  • GAMP 5 V-Model (software validation)
  • ICH Good Clinical Practice (GCP)
  • Declaration of Helsinki, German national regulations and GDPR
  • HIPAA (US health data privacy)

1 Compliant, not certified2 The tester has full knowledge of the system being tested3 Conducted in 2020–22 for the COVID-19 symptom diary and contact tracing project

Data Security

Made in Germany

At Climedo, data security comes first. Our hosting partner, from whom we lease servers, is ISO 27001 certified (Standards for Information Security Assurance). In addition, we rely on strong data separation and state-of-the-art encryption methods. At the federal level, our system has also been tested by the BSI and the BfDI.

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We offer different packages and prices - tailored to you and your needs.