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

Climedo is built for decentralized and hybrid studies: combine eCOA/ePRO, eCRF, eConsent and eSurveys as your study needs. You capture high-quality data and run studies quickly, securely and cost-effectively.

For serious adverse events (SAEs), real-time overviews show at once what happened, so you can react faster. That improves patient safety.

Patient Recruitment & Retention

With eConsent, patients read the consent documents at home, take their time to understand them and sign digitally. During the study, the electronic patient diary (eDiary/ePRO) reminds them of upcoming entries by SMS or email, no app needed.

This lets you follow patients closely from a distance and over long periods. It keeps them in the study and eases the burden on physicians.

Real-World Data (RWD)

Study designs are getting more complex and need larger, more diverse groups of participants. Real-world data can help here.

Our interfaces bring real-world data together and enrich it with existing data, such as lab values or electronic health records (EHR).

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.

AUDITABLE AND VALIDATED

The Climedo system is validated and auditable 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 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 certified

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.