Empower Patients With Hybrid Trials

Our hybrid (or Decentralized Clinical Trials / DCT) platform enables you to implement studies in a patient-centric, flexible and decentralized manner. Enable your patients to participate remotely while saving time, costs, improving patient compliance and taking the burden off study sites.

DCT – ready for the future?

Collect high-quality data for your clinical trials with our Electronic Data Capture (EDC) solutions.

Patients receive reminders via various devices (smartphones, tablets, wearables) and fill out their patient diaries online. Integrate medical wearables and bring the clinical trial to patients' homes with remote televisits.

Climedo Ecosystem

Hybrid Studies

With Climedo, you'll be perfectly equipped for DCTs: Hybrid studies can be easily combined with our modules such as eCOA/ePRO, eCRF, eConsent and eSurveys.

Increase your data quality with our DCT platform and conduct studies quickly, securely and cost-effectively. In addition, patient safety is significantly improved in case of serious adverse events (SAEs) thanks to real-time overviews.

Patient Recruitment & Retention

With eConsent, patients can inform themselves in peace at home and read, understand and sign the consent documents. During the study, the electronic patient diary (eDiary/ePRO) automatically reminds participants of upcoming reports by SMS or e-mail – without an app.

This allows decentralized, close-meshed monitoring and long-term patient follow-ups. This not only increases patient compliance but also relieves the burden on doctors.

Real-World Data (RWD)

Clinical trial designs are becoming increasingly complex, which is why we need larger and more diverse pools of study participants. Real-World Evidence (RWE) can be applied to clinical trials with the latest technological advances on a whole new level.

In this way, real-world data (RWD) can be merged via our interfaces and enriched with existing data, such as laboratory data and electronic patient records (ePR).

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.

Advantages With Climedo

PATIENT CENTRICITY

Focus on patient centricity and improve your patient recruitment and retention.

MORE SCALABILITY

Thanks to purely electronic data capture and a one-time set-up, your clinical trials are quickly and easily scalable for future projects.

REAL-TIME DATA

A unified, centralized and cloud-based platform connects all clinical trial participants in a cost-effective, secure and decentralized way. View all data points and developments in real time.

QUALITY AND QUANTITY

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

INCREASED DIVERSITY

Improve your database with a more diverse patient population. Thanks to the siteless setting, people from different countries, both male and female, and regardless of age or physical limitations can take part.

EXTENDED PATIENT RECRUITMENT

Complement your offline recruiting with online recruiting strategies and access new patient groups. Our partners will support you in this.

LESS DOCUMENTATION EFFORT FOR SITES

Lower the burden on your sites with reduced duplicate entries, automated data capture via wearables and direct patient input.

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