The Heart of England NHS Foundation Trust are a national centre for clinical research and can provide care for patients across the UK within their excellent facilities at the purpose-built research unit MIDRU – (Medical Innovation Development and Research Unit, Heartlands site) and within Good Hope and Solihull Hospitals.
A multi-million-pound investment into clinical trials has provided facilities to undertake a wide range of clinical trials with the addition of seminar and conference rooms. It is home to dedicated research teams consisting of doctors, nurse and other support staff and a purpose-built clinical trials pharmacy department.
The pharmacy team based at MIDRU consists of Pharmacists, registered technicians and clerical staff who together run and maintain a large number of drug trials (CTIMPs – Clinical Trial of Investigational Medicinal Products) mainly working within phase III
The pharmacy department’s responsibilities include:
- Study monitoring
- Reporting of Adverse Drug Reactions, Adverse Events, Serious Adverse Events, SUSAR (Suspected Unexpected Serious Adverse Reaction) if necessary
- Emergency unblinding
- Investigational Medicinal Product (IMP) recall
- Reporting serious breaches
- Reporting errors
- Reporting fraud
- Safeguarding subjects, healthcare professionals and the Trust by ensuring IMP are appropriate for use and are procured, handled, stored (including its temperature monitoring) and used safely and correctly
- Ensuring that IMP are managed and dispensed to patients in accordance with the protocol
- Ensuring that all pharmacy clinical trial procedures comply with relevant guidelines and regulations
The pharmacy team will review a clinical trial protocol before giving its approval. This is a vital stage of the Trusts Research and Development approval process as pharmacy has to ensure clinical efficacy and proper code of conduct for maintaining and running the clinical trial in line with legislation and law.
We are in close contact with the pharmaceutical sponsoring companies and liaise with Clinical Research Associates every day of the week to ensure streamline working relationships.
Please visit www.midru.com for more information regarding the Trusts research activities and up to date information regarding open days.
You will also find monthly newsletters, podcasts and what the facility has been getting up to in general.