Meet our regulatory team

A Clinical Project Manager (CPMs) is allocated to your trial, and manages all its regulatory and administrative aspects, from first enquiry to completion of clinical report. The CPM is responsible for the preparation, review and coordination of the key trial documents required for your ethics and regulatory submissions. All our CPMs undergo extensive training in GCP; regulatory and ethical requirements; design and conduct of clinical pharmacology trials; and medical writing. Thus CPMs offer key advice and assistance in gaining approvals for your trial.

If your trial involves patients, we’ve a specialist Patient Trial Coordinator who coordinates submissions to the Clinical Research Network (CRN), and helps identify patient identification centres (PICs).

Services we offer

  • Helping with trial design – our CPMs and physicians have a wealth of experience and training in trial design, and are happy to assist you, and we offer protocol writing as a service. Our CPM and medical writing team have extensive experience of successful applications, and will write the protocol in line with all current regulations and with a sound knowledge of HMR procedures, to ensure that your trial runs smoothly. Please visit our trial design page for more information.
  • Review of protocol, Investigator’s Brochure (IB), and other documents essential for your application.
  • Writing and preparation of applications and all relevant documents. Our CPMs are trained in medical writing, and prepare all documents with a regulatory perspective in mind.
  • Submission of initial applications, amendments, and post-approval reporting (declaring a trial over; upload of trial results to EudraCT). Here are some examples of what we do.
    • Application to the ethics committee – we have ethics committees that we use regularly, who are familiar with our documents and give us favourable feedback on their quality. We prepare the IRAS form, Information and Consent Form (ICF), and all other submission documents.
    • Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) – we have a long experience in all aspects of the application process, including creating the CTA form. Please contact us if you want to discuss IB and IMPD writing services.
    • Combined Ways of Working (CWoW) – HMR is taking part in a new pilot scheme, where a single application is submitted to the REC and MHRA, who review the application in parallel and give a single, joint opinion on the trial. The main advantage of this approach is that it can eliminate inconsistencies in the approval status of documents, and thus optimises approval timelines. Please contact us if you’d like to discuss CWoW further.
    • ARSAC submission – our Chief Medical  Adviser is an ARSAC licence holder, and works with our external Radiation Physicist to obtain all necessary permissions for trials involving radioactive materials.
    • Health Research Authority (HRA) submissions – we’ve vast experience of reviewing and writing documents for patient trials that involve the National Health Service (NHS).

Our accreditation and experience

HMR has Phase I accreditation from the MHRA to conduct first-in-human clinical trials, including those that require review by the MHRA’s Expert Advisory Group (EAG). In 2008, we were the first phase 1 unit to receive that supplementary accreditation from the MHRA.

We also have Federal Wide Assurance (FWA) and are registered with the Generic Drug User Fee Amendments of 2012 (GDUFA), which allows us to do trials sponsored by the USA government, including clinical bioequivalence trials.

We keep up to date with changes in regulatory requirements by searching UK and European clinical trials regulatory websites, including the European Medicines Agency, MHRA and Health Research Authority: we update staff and our SOPs as required. Dr Malcolm Boyce is a member of the MHRA GCP Consultative Committee and the NRES Phase 1 Advisory Group, and wrote the 2007 edition of the ABPI guidelines for phase 1 clinical trials.