Services

Who We Are
  • Phase 1
    close

    HMR
    HMR

    We specialise in phase 1 trials of investigational medicinal products (IMPs). We are accredited by the MHRA to do all phase 1 trials, including ‘higher risk’ trials.

    • First-in-man trials – about one-third of our trials are of the very first administration of an IMP to humans
    • Bridging trials – we have an experienced team of 15 bilingual nurses and graduates dedicated to Japanese bridging studies; we’ve also done bridging studies in Chinese and Korean volunteers
    • Ascending dose trials – we offer rapid turnaround of data and robust procedures for dose escalation
    • Radiolabelled IMPs (ADME, microdosing and ‘light label’ studies) – our radiopharmacy and on-site laboratory make us the ideal centre for trials of radiolabelled IMPs; we collaborate with Xceleron on microdosing and ‘light label’ studies
    • PET – we collaborate with Imanova, Hammersmith Hospital, on PET and fMRI studies
    • ‘Umbrella’ protocols – single/multiple ascending doses, incorporating food effect and special populations (eg women, ethnic groups, patients)
    • Bioequivalence and bioavailability
    • Evaluation of biosimilars and ‘biobetters’
    • Pharmacodynamics and biomarkers – we use a wide range of clinical and laboratory methods
    • Drug interactions
    • Thorough QT
    • Specialist studies: audiometry, sleep, endoscopy, respiratory function
    • Special populations:
      • elderly
      • post-menopausal
      • surgically sterilised
      • smokers
      • ethnic groups
      • obese
      • alcohol-dependent
      • genetic polymorphisms
    close
  • Patient studies
    close

    Patient studies

    Phase 1 trials and early phase 2

    Proof-of-principle

    • Asthma
    • Allergic rhinitis
    • COPD
    • Diabetes
    • Migraine
    • Angina
    • Prostatic hypertrophy
    • Male erectile dysfunction
    • Herpes infection
    • Pre-menstrual syndrome
    • Idiopathic pulmonary fibrosis
    • Down syndrome
    • SLE

     

    Click here to find out more about allergy trials.

    close
  • Products studied
    close
    • Small molecules
    • Monoclonal antibodies
    • Proteins, peptides, cytokines
    • Vaccines
    • siRNA
    • Spiegelmers
    • Anti-sense compounds
    • Genetically modified micro-organisms
    close
  • Finding volunteers
    close

    • Dedicated team of 25 recruiters
    • Databases of:
      1. young
      2. elderly
      3. postmenopausal
      4. surgically sterilised
      5. smokers
      6. obese
      7. alcohol-dependent
      8. patients, eg asthma, migraine, diabetes
      9. Japanese and other ethnic groups

    Find out more about bridging trials in Japanese subjects.

    close
  • Pharmacy
    close


    On-site pharmacy with MIA(IMP) licence, offering the following services:

    • Expert advice during development of the IMPD and protocol, and beyond
    • QP audit and importation of IMP into EU
    • Randomisation, repackaging & relabelling
    • Manufacture of bespoke capsules
    • Preparation of solutions, suspensions & semi-solid formulations
    • Aseptic preparation
    • Radiopharmaceuticals
      (including aseptics and light label)
    • Sterilisation by filtration
    • Over-encapsulation of tablets & capsules
    • Preparation and storage of controlled drugs
    • Preparation of handling instructions
    • QP batch certification
    • Sourcing of comparators & non-IMPs
    • Manufacture of IMP for other clinical trial sites
    • Retention samples
    • Certified IMP destruction

    Take a photo tour of the pharmacy.

    The Pharmacy has its own dedicated website.

    close
  • Laboratory
    close
    • On-site accredited pathology laboratory
    • Expert advice during protocol development and beyond
    • Extensive catalogue of clinical pathology tests & biomarkers
    • Method transfer and validation of new tests
    • Specialist techniques, including:
      • Platelet function
      • Cell stimulation and separation
      • Flow cytometry
      • Radio-immunoassay
      • UHPLC
    • Consistent methodology throughout a clinical trial
    • Established reference ranges, based on a large population of healthy volunteers
    • Full integration of laboratory and clinical services

    Take a photo tour of the laboratory.

    The laboratory has its own dedicated website.

    Hammersmith Medicines ResearchHammersmith Medicines Research

    close
  • Quality services
    close

    Hammersmith Medicines Research
    Hammersmith Medicines Research

    • ISO 9001 certified quality system since 1999 (currently ISO 9001:2008)
    • Dedicated, independent QA team
    • Risk-based audit plan tailored to each study
    • Audits at key stages of clinical studies at HMR:
      • key study documents
      • ward, pharmacy and laboratory procedures
      • master file
      • database
      • tables, figures and listings
    • Facilities audits
    • Systems audits
    • Subcontractor audits
    • Audits of validation of computerised systems

     

    View our ISO 9001:2008 certificate.

    close
  • Data management
    close

    Hammersmith Medicines Research
    Hammersmith Medicines Research Hammersmith Medicines Research

    We provide efficient, high quality data management and statistical support for early phase clinical trials conducted at HMR or external sites. We follow CDISC (Clinical Data Interchange Standards Consortium) standards (including CDASH and SDTM) to maximise efficiency and ensure that the data comply with regulatory requirements. We offer a flexible bespoke service, using either our own or our customer's templates and standards.

    We pride ourselves in providing high quality data on time, every time.

    CRFs and databases – we offer paper-based and electronic data management. Both systems allow us to deploy databases rapidly and to respond quickly to protocol amendments. All our systems are 21 CFR Part 11 compliant and validated for use by HMR.

    • Paper-based data management – we design a paper CRF (using HMR's template) and build the database in ClinPlus, a SAS-based data management system from DZS Software Solutions. Our experienced data entry operators do double data entry.
    • Electronic data management (eDM) – we use Medrio e-clinical to design and build an eCRF (using HMR's template) and database. Data are entered by study site staff. Customers benefit from rapid, remote access to their data in Medrio e-clinical.

    Data checks – we write a comprehensive data validation specification for each database. We program each check (using standard macros for efficiency), and test them using correct and incorrect dummy data.

    Query management – programmed and manual queries are managed through the data management software. We actively manage the query process to ensure rapid resolution.

    Medical coding – when required, we code medical history, adverse events and medication using MedDRA and WHO DDE.

    Data reconciliation – before database lock, we reconcile serious adverse events in our database with pharmacovigilance databases and we reconcile other external electronic data.

    Database lock – we follow comprehensive quality control procedures before locking each database, to ensure that we deliver high quality data, every time.

    Data transfer – we transfer interim and final data to customers in SDTM, or their requested format.

    View our Data Management brochure.

    close
  • Statistics and pharmacokinetics
    close

    Hammersmith Medicines Research

    We provide efficient, high quality data management and statistical support for early phase clinical trials conducted at HMR or external sites. We follow CDISC (Clinical Data Interchange Standards Consortium) standards (including CDASH and SDTM) to maximise efficiency and ensure that the data comply with regulatory requirements. We offer a flexible bespoke service, using either our own or our customer's templates and standards.

    Protocol input – our statistical input includes study design, sample size calculations, statistical methods and consultancy advice during study setup.

    Randomisations – we advise on randomisation strategy in complex studies, produce randomisation lists and emergency unblinding envelopes.

    Statistical Analysis Plans – our experienced statisticians prepare statistical analysis plans, which include output shells.

    Interim analyses – we routinely analyse PK and PD data, with a very rapid turnaround, to support dose decisions. We ensure that blinding is fully protected by carefully limiting outputs and using a statistician and unblinded SAS programmer who are independent of the study team.

    Pharmacokinetics – we derive PK parameters, in plasma, serum and urine, for interim and final analyses. Our statisticians have extensive experience in bioequivalence, drug-drug interaction, repeated-dose, bridging and dose proportionality studies.

    Output production – we program all tables, figures and listings using SAS. Our comprehensive quality control procedures, including independent programming, ensure that we deliver high quality outputs every time.

    Statistical consultancy – our experienced statisticians provide statistical consultancy to other aspects of clinical development, including shelf-life estimates and validation of laboratory assays.

    close
  • Medical writing
    close

    Hammersmith Medicines Research

    Trial documentation

    • Protocol
    • Investigator's brochure
    • IMP dossier
    • Information and consent form
    • CRF

    Application to regulatory bodies

    • CTA application
    • Ethics committee application
    • NHS R&D application
    • ARSAC application

    Reports

    • Integrated clinical report (ICH compliant)
    • Interim report
    • Pharmacokinetic report
    • Statistical report

    Abstract or manuscript for publication

    close
  • Ethics
    close
    • Over 600 applications since 1993
      • wide choice of UKECA-approved committees
      • as little as 4 weeks from submission to approval
      • experienced coordinating site for multicentre trials
    • Experienced in IRAS – UK's web-based application system
    • Experienced in obtaining NHS management permission (R&D approval) and use of the NIHR coordinating system for gaining NHS permission (CSP)
    • Advice on ethics committee applications and amendments
    • Post-approval:
      • amendments
      • investigator's annual report
      • pharmacovigilance reports
      • notification of temporary halt, serious breaches
      • declaration of end of trial
    • Approved protocols for healthy subjects and patient subjects, eg asthmatics, for generic ‘panel’ screening
    close
  • Regulatory services
    close

    Regulatory Services

    • Investigator's brochure
    • IMP dossier
    • CTA application & amendments
    • Post-approval reporting – as for Ethics
    • Regulatory advice:
      • protocol
      • amendments
      • pharmacovigilance
      • serious breaches of GCP
    • Experienced user of the Common European Submission Platform (CESP)
    close
  • back to top