Capabilities

Our Capabilities

See What We Can Offer You

• AME Oncology

  AME Oncology

  • Access to varying oncology patients such as solid tumours and lymphomas
  • CRU licenced for the handling of 14C samples
  • On-site scientist with expertise in Drug Metabolism
  • Radiopharmacy for the storage, dispensing and disposal of 14C IMP
  • GMP 14C API synthesis, Drug Product formulation and testing available through Arcinova located in the UK
  • GLP 14C radioanalysis and metabolite profiling available through Covance located in the UK

• Archiving

  Archiving

  • Archive to store source data and CRFs on site for audited external provision off site for long-term

• Cardiology

  Cardiology

  • Heart Failure Clinical Trial Experience
  • Ischemic Heart Disease Clinical Trial Experience
  • Stroke Clinical Trial experience
  • Access to cardiorespiratory exercise testing
  • Access to transthoracic and transoesophageal echocardiography
  • Access to vascular ultrasound (incuding Doppler and endothelial function)
  • Access to platelet function testing

• CNS

  CNS

  • Experience in Epilepsy Clinical Trials
  • Access to schizophrenia patients
  • Access and experience in Multiple Sclerosis clinical trials
  • Excellent lumbar puncture experience including up to 72h continuous CSF
  • Access to gait analysis
  • Nuerodegenarative Diseases covered in more detail under separate heading

• Data Management

  Data Management

  • Data Management team, to develop eCRF and provide ongoing data management services
  • Data entry team, to perform data entry, QC, query resolution

• Dermatology

  Dermatology

  • Robust database of atopic dermatitis and psoriasis patients
  • CRU Physicians trained in PASI scoring
  • Expertise in skin biopsies
  • Experience in numerous dose routes including topical

• Dose Escalation

  Dose Escalation

  • Support Study Deign & Protocol writing for Dose Escalation research
  • Develop Dose Escalation Charters
  • Collaborative working across the Clinical Statistical and Data Team to produce high quality QC data for safe, reliable Dose Escalation Decision making.

• Dose Routes Utilised

  Dose Routes Utilised

  • Oral
  • Intravenous
  • Subcutaneous
  • Intramuscular
  • Intradermal
  • Topical
  • Ocular
  • Intrathecal
  • Inhaler

• Regulatory Submissions

  Regulatory Submissions

  • Dedicated Trial & Project Managers to complete full regulatory submission requirements

• First In Man

  First In Man

  • Expertise in dose escalation and robust procedure for risk management
  • Clinical Pharmacologists as PIs to support starting dose decisions
  • MHRA accreditation processed to support delivery of First in Man Studies
  • Ability to design flexible protocols to reduce need for substantial amendments and unnecessary delays
  • Ability to cohort patients where recruitment rates allow

• Gastroenterology

  Gastroenterology

  • Experience /access in Inflammatory Bowel Disease
  • Access to hepatically impaired patients
  • Access to Irritable Bowel Syndrome/Ulcerative Colitis patients
  • Access to full endoscopy facilities including upper GI (gastroscopy, push enteroscopy), whole GI (capsule endoscopy) and lower GI (proctoscopy, sigmoidoscopy and colonoscopy)
  • Access to liver biopsy

• Infectious Diseases

  Infectious Diseases

  • COVID

• Laboratory

  Laboratory

  • The CRU has an on-site laboratory for sample processing, storage and shipment. The laboratory has the ability to centrifuge samples at room temperature or refrigerated. It has access to a top pan and analytical balance, pipettes, fume hood and isolator. In addition there are refrigerated, -20C and -80C storage, all with central temperature monitoring and alarm systems.
  • More specialised laboratory procedures such as preparation of PBMCs or advanced sample processing are also available through our GCLP network and Bioanalytic Facility within the Liverpool University

• Metabolic Medicine and Diabetes

  Metabolic Medicine and Diabetes

  • Access to Hypercholesterolaemia patients
  • Access to Type I/Type II Diabetes patients including those with complications such as retinopathy, leg ulcers, nephropathy
  • Experienced in Insulin Clamp techniques (euglycaemic and hyperglycaemic)

• Monitoring

  Monitoring

  • Can provide in-house monitoring capabilities
  • Excellent facilities with high speed WiFi access and spacious rooms for visiting Monitors

• Neurodegenerative Diseases

  Neurodegenerative Diseases

  • Experience/Access with Alzheimers, Parkinsons and Huntingtonpatients
  • Excellent lumbar puncture experience including up to 72h continuous CSF
  • Access to MRI inlcuding fMRI and PET/CT including utilsing flurbetapir
  • Experience/Access to cognitive raters

• Quality Assurance

  Quality Assurance

  • Independent QA department within the Liverpool University Hospital Foundation Trust
  • Conduct audits of the CRU and Vendors
  • Host Sponsor or Regulatory audits

• Pharmacokinetics

  Pharmacokinetics

  • Access to Pharmacokineticists through the University
  • Expertise in PK/PD relationships for anti-microbrials
  • Population PK

• Pharmacy

  Pharmacy

  • On site dedicated Clinical Trials Pharmacy
  • On site Radiopharmacy
  • Aseptic Phamacy

• Phase I

  Phase I

  •  Experience in Phase I Clinical Trials in patients, healthy volunteers and special populations

• Products Handled

  Products Handled

  • Small molecule
  • Biologics including mAb, RNAi
  • Genetically modified advanced therapeutics
  • High risk drugs requiring EAG review
  • Cytotoxics
  • Radiolabelled compounds
  • Medical Devices

• Protocol, IB & Document Development

  Protocol, IB & Document Development

  • Can provide in-house protocol writing services for Phase I and FIM studies, IB, Study Manuals for example Laboratory and Pharmacy; Study Charters for example Dose Escalation; Study Documents for example PIL and ICF

• Renal Impairment or Clinical Trials in Renal Patients

  Renal Impairment or Clinical Trials in Renal Patients

  • Robust database of renal patients including mild, moderate, severe and patients on dialysis (peritoneal and haemodialysis)
  • Experience in collection of dialysate fluid

• Recruitment

  Recruitment

  • Dedicated Recruitment Manager and recruitment team
  • Consent4Consent allows access to patients medical records to allow prompt pre-screening
  • Access to robust healthy volunteer database
  • Robust databases already established for renal, dermatology and RA patients. Building new databases for IBD and UC

• Regulatory Services

  Regulatory Services

  • Regulatory Services can be outsourced on your behalf

• Respiratory Diseases

  Respiratory Diseases

  • Database of asthma and COPD patients of varying severities
  • Expertise in different drug delivery types including inhalers etc.
  • Spirometry access and expertise
  • Ability to perform bronchoscopies and bronchioalveolar lavage within the CRF
  • Additional cardio-respiratory investigations
  • Access to metacholine challenge

• Report Writing

  Report Writing

  • Report Writing Services can be provided Statistics

• Statistics

  Statistics

  • Access to Dedicated Early Phase Statistician
  • Statistics Services can be outsourced on your behalf

• Vaccine Trials

  Vaccine Trials

  • Experienced with high volume healthy volunteer vaccine trials
  • Robust database of healthy volunteers
  • Experience with Pneumococcal Challenge to test efficacy of Pneumonia vaccines