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.
|