The Next Generation of Interactive, Patient-Centric Studies
The patient at the center: a user-friendly, simple and intuitive design ensures high adherence and completion rates.
The patient at the center: a user-friendly, simple and intuitive design ensures high adherence and completion rates.
From the first scan to the last questionnaire, patients take part from home. Your team sees every step in real time.
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.
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.
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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.
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.
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.
We'll show you how to start a clinical trial or survey and address your specific needs and desires.
Patients are motivated to enter their data regularly and on time, thanks to automated reminders.
Climedo's ePRO is browser-based, optimized for any common device and immediately usable. There is no need to install an app.
Thanks to automated processes, administrative tasks are eliminated. This goes hand in hand with a significant reduction of time and costs.
Collect more valid data faster through electronic data capture and flexible patient participation.
Smart views and individual, clear dashboards enable effortless data analysis.
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.
No sponsor, CRO or other customer has ever stopped or cancelled an engagement with Climedo due to an audit.
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.
Compliance with:
1 Compliant, not certified
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.
Thomas Huber
Head of Data Management, Pharmalog Institute for Clinical Research
Case Study
