orangeglobal
Your specialist for clinical and pharmaceutical trials
Qualified support in the selection of CROs for your clinical trials
The choice of CRO is vital for the success of your clinical trials. As a result of our large network and our experience of working with CROs throughout the world, we can identify those that are most appropriate for your specific needs and so ensure the success of your clinical trials.
It goes without saying that we also undertake the management of your trials as a liaison between you, the CRO and the authorities:
- Support in tendering
- Cost/service comparison
- Monitoring of compliance with the protocol, GCP and regulatory requirements
- Communication and reporting
Patient Reported Outcome (PRO) – Linguistic Validation in clinical trials
Patient-reported outcome (PRO) measurements are becoming an increasing focus of interest for research-based pharmaceutical companies and CROs in the design of drug trials in order to demonstrate the benefit of new treatments early on by means of the patient’s subjective assessment.
PROs also play an ever increasing role in healthcare research, in other words in the trialling of treatments under everyday conditions and hence in the inclusion of the patient in the assessment of treatment processes. orangeglobal produces all the documents you need, such as the questionnaires for each field of use, and provides validated and harmonised translations as well as the necessary cultural adaptations in a six-stage process in line with the ISPOR Task Force for Translation and Cultural Adaptation, and with EMA and FDA GCP guidelines.
We conduct patient-reported outcome (PRO) studies in clinical trials or in healthcare research and ensure the high-quality translation of all documents. With optimised processes for your clinical trials we lay the foundations for the successful registration of your medicinal products on international markets.
PatientConcept App
PatientConcept is a medical app that connects the participants of a care study directly with the Study Nurse or Doctor in accordance with the current rules of the data protection. Please continue reading "PatientConcept - The Key to the Patient".