Phase 1 Clinical Trials
MHRA Accredited Phase 1 Unit at the Manchester Royal Infirmary campus.
The MAC Clinical Research Early Phase Unit (EPU) has already completed its third First in Human (FIH) study since being accredited by MHRA in October 2016 for the conduct of Phase 1 trials with all types of new molecules. Current thinking is that such units are best situated on a hospital campus.
The Manchester Royal Infirmary is the biggest hospital campus in the north of England and we are proud to be associated with the Central Manchester NHS Foundation Trust whose emergency systems extend to our EPU.
MAC Clinical Research, with its extensive network of UK patient centres, has an excellent reputation based on the ability to recruit patients for the effective and timely completion of clinical trials. Using this expertise in recruitment to power our EPU means that we have already conducted two large, early phase studies in specific patient populations where in-patient stays and safety monitoring were mandatory and we are about to embark on another such study, this time in Diabetics.
Safety is our watchword and our brand new, spacious unit is built with this in mind. We are situated in a new building dedicated to the advancement of medical science and are equipped with a state of the art Mortara Cardiac Telemetry system, with the ability to send 24 hour data online as well as having prompt review of 24 hour Holter monitoring with direct access to Cardiology when there are any anomalies.
Our staff are our strength and our unit is approved, by the Faculty of Pharmaceutical Medicine, as a training centre for physicians who are studying to become accredited FIH Investigators: we have a total of 6 physicians on site in Manchester. All of our senior nurses have extensive experience in clinical research and are supported by a team of Clinical Trial Assistants who are mostly at Masters or Doctorate level of training.
Clinical research continues to become more scientifically complex and more tightly controlled. Many studies involve “Umbrella” protocols which are endeavouring to combine FIH with First in Patient studies – we have extensive experience of this process and indeed some of our initial studies have taken this approach.
Overview of Early Phase Unit:
Thirty-two beds for high-intensity safety monitoring arranged in four bays of eight beds
4 Individual rooms in one area – flexible use as screening, consulting or overnight rooms
2 x 3 bedded rooms (can house patient and carer)
Patient lounge, eatery and kitchen
Nurse alarms at each bed
Nurses station giving a full 360 degree view of bays
8 channel 5 and 10 lead Mortara Telemetry system wireless and centrally monitored. Automated 12-lead ECG capture on studies and transmit information to central over-reader
MAC is the only private company which has 24/7 emergency support from hospital resuscitation team, all physicians ALS trained, all clinical staff ILS trained
Dedicated laboratory area, alarmed temperature monitoring throughout building with dial-out in case of temperature issues