News

MHRA Phase 1 Accreditation

HMR is the first phase 1 unit in the UK to pass the MHRA inspection for Standard and Supplementary Accreditation. So, we're approved for the conduct of trials of IMPs that need review by the MHRA Expert Advisory Group. Early accreditation is a tribute to our fierce commitment to quality and safety in everything we do, and confirms our status as one of the leading clinical pharmacology units in Europe.

Of course, most IMPs don't need review by EAG – but it's reassuring for our sponsors to know that we're accredited for all types of IMP and for the widest possible range of trials.

Click here to view our accreditation certificate.

HMR's 100^th external audit

Over the last 13 years, we have had 2 GCP inspections (1 voluntary inspection by the MCA in 1999 and 1 mandatory inspection by the MHRA in 2006); 2 MHRA GMP inspections (1 in 2004 in order for us to obtain our MA(IMP) licence and another mandatory inspection in 2006); 11 ISO 9001 assessments; 3 CAP inspections; and 95 audits by sponsors.

HMR's 10^th ISO 9001 assessment

HMR had its 10^th successful ISO 9001 assessment in August 2005. ISO 9001 is an internationally recognised standard for quality management systems. We achieved ISO 9001 certification in May 1999. Our assessors, SGS Yarsley, raised no non-conformances, and requested no corrective action. Only 1–2% of companies achieve that standard at the first assessment. In September 2003, we achieved certification to the revised ISO 9001:2000 standard. The new standard places greater emphasis on customer satisfaction, training and continual improvement.

Click here to view our ISO 9001 accreditation certificate.

Dr Kate Darwin appointed Director of Clinical Science

As part of our continual drive to enhance the quality of our clinical trials and reports, we've promoted Kate Darwin to the crucial new post of Director of Clinical Science. In the context of ever-increasing regulation and inspection, we needed somebody with a strong background in quality to oversee all our projects, and to ensure that they comply with the most stringent regulatory requirements. Kate has an outstanding record in academic science, and gained a DPhil at Oxford University before she joined HMR in 1998. She now has 8 years' experience of quality management, medical writing and regulatory compliance in phase 1, and has been responsible for quality assurance in relation to nearly 300 successful trials. We are confident that this new appointment will enable us to give improved service to our clients and trial sponsors.

Click here to find out more about Kate Darwin.

HMR wins National Training Award 2004

At a gala ceremony in October 2004, we received a National Training Award for our unique GCP training course for nurses and science graduates. It's the most prestigious of the UK awards for training and developing people. For a full press release, click here.

HMR complies with EU Clinical Trials Directive

We were fully compliant with the EU Clinical Trials Directive before it came into effect on 1 May 2004. The MHRA inspected our pharmacy in April 2004, after which they gave us a Manufacturer's Authorisation to import, assemble and repackage IMP, and awarded Qualified Person status to 4 of our staff to release batches of IMP. Call Malcolm Boyce (Clinical Director) on 020 8961 4130 for more information.

The register of holders of a Manufacturer's Authorisation for IMP is posted on the MHRA website: Click here to view.

100^th student enrols on our GCP training course

The 100^th member of HMR staff has now enrolled on our GCP training programme for nurses and science graduates. So far, 35 staff have completed the course. Click here to read more about it.

Important news about TOPS

TOPS (www.TOPS.org.uk) is a UK database that we developed to prevent healthy volunteers from taking part in clinical trials too often. TOPS has been accepted as a charity, because it's run for the good of the public. Also, the UK Government has given us permission to use National Insurance numbers to identify UK citizens.

Click here to read our TOPS newsletters.

Flow cytometry to assess new medicines

This year, our CAP-accredited laboratory has gained further experience in measuring the effects of new medicines by flow cytometry. For more information, call Juan Naveda (Head of Laboratory Services) on 020 8961 4130.

HMR starts 400^th trial

We specialise in phase 1 and early phase 2 trials – in all, about 40 per year. We have started over 400 trials since 1993 – most involve new medicines, and about one third involve the very first administration of a new medicine to humans.

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