Truly validated 24/7 medical safety monitoring

10/06/2015

Secure your patients safety using the only truly validated 24/7 medical safety monitoring system

Patient safety is critical during clinical trials.

Selection of monitors for safety reporting ultimately lies with the sponsor, however, when outsourcing medical monitoring requirements this has often been an ad hoc process with no adequate audit traceability. This is not the fault of the sponsor; audit trails have simply not been available.

Onorach now offers Promedim 24, a 21 CFR part 11, ICH E6 & Annex 11 compliant and validated App/On-line platform that supports emergency 24/7 medical coverage of clinical trials with full audit traceability and dynamic reporting of physician availability.

 

With a dedicated team of internal physicians that can be utilised as and when required on a trial by trial basis the Promedim 24 fully validated medical safety monitoring solution ensures 24/7 real time coverage is maintained by allowing physicians to register their availability via our on-line or smartphone/iOS App and additionally provides access to our secure study protocol repository.
The Promedim 24 control centre, technology platform and medical team combine to ensure that the service allows customers to completely comply with regulatory expectations.

Promedim 24 is a scalable, compliant and validated platform that ensures visibility for sponsors, clients and physicians within a system where control of physician availability is maintained and an audit report of coverage can be produced at any time.

 

In addition to the emergency 24/7 out of hours coverage supported by the Promedim 24 technology App, Promedim provide experience medical monitors to provide the GCP required oversight and medical support for the implementation of your development programmes, supporting investigators, providing a safety overview for the study population and maintaining a consistent scientific quality.

Medical monitoring with Promedim provides the following services:
•    Emergency 24/7 out of hours coverage
•    Day-to-day project support
•  Prior to the first patient entering, our medical monitors can help in training and liaising with investigators as well as writing the medical monitoring plan that will dictate the way medical coverage is provided. Additional activities include:
•    Reviewing eligibility criteria
•    Responding to non-urgent queries from sites and project teams
•    Review of alert lab values and SAEs
•    Scientific data review

Data quality can be further improved by a scientific review from a medically trained eye of the CRF or patient profile. Our medical monitors review:
•    For medical plausibility and sense check
•    Medical history and eligibility
•    To identify hidden SAEs
•    To affirm the study primary endpoint data
•    Concomitant medication.

Client Testimonial

Onorach has demonstrated competence in work with authorities and with sites. The team of Onorach is impressive in terms f creativity and goal orientation. It was always a pleasure to cooperate with Onorach.
SilvExpo