Developing a new medicinal product is a long and complex process, from modelling of the new compound through to the granting of Marketing Authorisation. Once a new drug has been developed, it has to be confirmed that it is effective and safe by using protocols involving substantial numbers of patients.
In the performance of clinical trials, the participating subjects undergo many examinations and a correspondingly large number of laboratory tests have to be performed. This is why Eurofins Biomnis has developed a special Clinical Trials Department.
As the largest independent clinical testing laboratory in Ireland, Eurofins Biomnis can satisfy all of your laboratory needs during your clinical trial. Our ISO 15189 accredited laboratory (as detailed in INAB Registration Number 159MT), comprehensive test menu, customised visit-specific collection kits and personalised service and care will enhance your ability to achieve faster data locks and product submissions.
Eurofins Biomnis relies on the experience of its 45 pathologists whose experience and up to date knowledge of new technologies enable them to meet the special requirements of clinical trials.
Eurofins Biomnis has four high-volume, state-of-the-art multidisciplinary premises which ensure that clinical trial requirements—in terms of quality and turnaround time as well as regulatory constraints—are fulfilled.
Testing for clinical trials is governed by strict quality criteria since Marketing Authorisation applications are particularly scrupulously assessed by the health authorities. Eurofins Biomnis can meet all the specific requirements in matters such as the record traceability, the archiving of raw data, electronic data transfer and support for auditing procedures as well as complementary services such as the Eurofins Biomnis serum library.
Eurofins Biomnis provides laboratory data collection and management services. Laboratory reporting system offers clients flexibility in customization while meeting their protocol-specific needs. For most analytes, we deliver reports to investigator sites within 72 hours of the patient visit. We also have the ability to fax reports to you or investigator sites within 24 hours of the patient visit.
All of our laboratory reports:
- Include patient demographic data.
- Contain the reference range associated with each analyte.
- Contain specimen collection information.
- Include additional patient or administrative information collected on the requisition, if requested by clients.
- May be designed to prompt the investigator for signature and comments.
- May be sorted in the order of investigator and patient to facilitate review.
- Can be offered as a laboratory cumulative report.