University Institutions

The Service of ECHOconsult:

At the beginning of a planned clinical trial ECHOconsult offers you consultation on the following aspects:

Finance and budget planning
Study design / study protocol
Ethical and legal requirements for study performance
Time frame and deadlines of the study process

ECHOconsult is happy to manage your project during the entire duration and establishes contacts with highly specialized service providers for the following tasks:

Study preparation / performance and project management

Management of the internal and external communication
Contacts to cooperation partners
Review/generation of study specific documents (study protocol, patient information, etc.) according to ICH/GCP
Handling of the approval procedure of the study with the authorities
Submission of the study documents to the competent Ethics Committees
Creation of the Trial Master File and the Investigator Site Files
Supervision and coordination of the study performance in accordance with time and budget
Coordination of the provision of study documents and investigational products
Control of the patient recruitment and patient documentation

Drug safety:

Processing of serious adverse events (SAEs)
Timely notification of suspected unexpected serious adverse reactions (SUSARs) to the competent authorities, the Ethics Committee and the investigational sites involved
Assistance with the preparation of the annual safety report for the competent authorities and Ethics Committees (annual safety report, ASR)

Quality assurance

Measures for quality assurance of study documentation and study conduct at the investigational site

Should you be interested, please contact me for further information.