Richmond Pharmacology Ltd

Committed to Clinical Excellence

Exploration
&
Discovery

3rd October 2008

 Exploration
&
Discovery

Introduction to RPL
• Privately owned CRO; founded in 2001

• UK’s largest full-service Early Phase CRO

• 2 x Integrated Early Phase Clinical Trial Centres

– total of 100 beds and additional outpatient facilities

• ~ 100 permanent staff

• Focus on Early Phase healthy volunteer & patient studies

• > 170 studies conducted to date

• 14-16 studies ongoing

 Management Structure

Dr Ulrike Lorch Dr Jörg Täubel Dr Radivoj Arezina

Medical Director Managing Director Research Director
PI PI Data Management and QC;
Pharmacy Services

Director of Finance: Mark Vaughan

Other board directors: Professor B Prichard; MZ Levine, L Levine (Chair)
RPL @ St. George’s Hospital
RPL @ Mayday Hospital
Thornton Wing

A&E

Main Entrance
 Trial Centre Locations
Site Services Beds Activities

St. George’s Hospital • Clinical

32 • Tertiary care patients (e.g. haemodialysis)
• Recruitment • Surgical studies
NHS Trust

St. George’s • ECG Core Lab

• Data Management
---- • Thorough QTc Studies

University London
• Professor A.J. Camm (+)

Mayday University • Clinical

• Screening
68 • Healthy Volunteer Studies
• Bridging Studies
Hospital NHS Trust
• Administration • FTIM
• PK/PD
• Elderly/Obese etc.
• Primary & Secondary care patients (e.g.
diabetes, asthmatics)
Subject Safety
• Subject safety paramount to RPL
• Gold-standard early phase facilities
– 2 acute university hospitals
– MSA for resuscitation facilities and training
– Staff regularly trained in resuscitation
• Layout of wards
– Constant supervision
– Alarm and emergency features
• Non-emergency medical issues
– Experts on site at both hospitals for referrals and consultations
 Exploration
• In/out patient facilities
&
Discovery
• Protocol writing / review

• On-site therapeutic consultancy

• Ethics submission

• Submission & Management of CTA’s

• R&D submission, where required

• CRF writing / review

Full-service CRO •

•
Volunteer recruitment

Project Management

• Pharmacy & Laboratory facilities

• Bioanalytical Partner Lab

• Statistical analysis

• Data management

• Final report writing

• Monitoring (QC)

• QA
 Exploration

Access to Experts
&
Discovery

• Scientific Advisory Board

– Prof. Prichard – Chair; Professor Emeritus of Clinical Pharmacology

– Prof. Anand – Professor of Neurology

– Prof. Camm – Professor of Cardiology

– Prof. Kaski – Professor of Cardiology

– Prof. McLean – Professor Emeritus of Toxicology

• External Experts

– Dr. Barnes – Department of Neurology

– Prof. Axford – Professor of Rheumatology

– Prof. Sir Anthony Coates – Professor of Microbiology

– Prof. Griffin – Professor of Medicine

– Dr. Muriel Shannon – Department of Haematology

Special Techniques
• Internal capabilities • Through external collaborations
– Radiological
– Telemetry • MRI
– Holter • Dexa
– Thorough QTc/Digital ECG recording/MUSE server • Transcranial doppler
– Finometer
• CT
– Cognitive testing/questionnaires/VAS/pain tests • X-rays
– Sway test • GI Transit
• X-rays
– Muscle function tests (Lafayette and
Accelerometer) – Cardiological
• Stress-ECG
– Lung function testing • Echo
– Ph – metry • Thallium-
– Gastrointestinal Intubation – Urological
• Urodynamic assessments
– Bleeding time assessments
– Surgical
– Saliva test • Surgical procedures/pain studies
– Sebum collection – All general hospital investigations
– Endocrinological tests
 Exploration
&
Discovery

Our Service Portfolio

• Healthy Volunteer and Patient Studies

• Japanese Bridging Studies

• QTc studies & Cardiac Services

• Healthy volunteer & patient recruitment specialist

• Data Management
 Exploration
&
Discovery

Healthy Volunteer Studies

• FTIH, TQT, Bio-equivalence, Interaction, PK/PD etc.

• 2 – 4 studies per month

• Variety of therapeutic areas

• The more ‘challenging’ volunteer panels

 Exploration
&
Discovery

Patient Studies
Type 1 Type 2 Type 3 Type 4

• Hospital based • Collaborate with a • Assist a clinical

• phase I platform
clinical academic academic Investigator
– Asthma – tooth
Investigator – Prof. Axford -
extraction
– Diabetes
– Dr. Barnes - RA Study

MS Study
 Bridging Studies

• Largest Bridging Study Provider in Europe

• Dedicated Japanese team within Richmond

• Japanese staff in Clinical Teams, Project Management,

Volunteer Recruitment and Business Development

• Highly targeted proactive recruitment strategy

QTc Studies – One Centre, One Solution
• The UK’s most innovative ECG core laboratory
• Latest ECG technology/software for analysis
• Experts from Protocol design to Regulators
• Close collaboration between clinic & QTc analysing facility
• Excellence of clinical conduct
• Highest quality of ECG measurement
• Reduced sample size and cost

• Prof. A. J. Camm MD., F.R.C.P., F.E.S.C., F.A.C.C.

• World-leading expert
• Head of Cardiac and Vascular Sciences at SGUL
• Involvement from Protocol Design to Final Report
• Longstanding alliance with RPL
 Volunteer Recruitment
“ The staff have been excellent…………I would definitely recommend trials4us to a friend.”
 Exploration
&

Recruitment process
Discovery

1. Search in our custom designed Volunteer Database

• currently containing over ~80,000 registrations

• medical records

• appointment booking system

• continuous metrics allowing precise recruitment predictions

2. Professional sales and marketing approach

• use of professional, innovative branded advertising campaigns

3. On site access to Consultants across 2 NHS Teaching Hospitals

• hospital bases provide huge variety of patient populations

Recruitment Brands
 Study Management @ RPL
Study Set-up:
• Logistics - Business Development, Contracts, Project Manager
• Scientific - Principal Investigator, Scientific Advisory Board, Study Physician, External Experts

Clinical & Post-Clinical Phase:

Scientific Advisory Board Principal Investigator External Experts

CORE PROJECT TEAM Project Manager

AUXILIARY TEAM
Study Manager
Pharmacy
Study Team Leader
Scheduling
Research Physician
Catering
Recruitment Project Manager
Supplies
Laboratory Technician
Medical Writing
Clinical Research Associate
Statistician
Data Manager
Cardiological
Sciences
 Exploration
&
Discovery

Why choose RPL?

• Gold-Standard in subject safety

• Study experience

• Recruitment expertise

• Therapeutic expertise – unique Locations

• Full Service Trial Centres

‘One Centre…..One Solution’

 Exploration
&
Discovery

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