PAREXEL International Ltd

Tel: +44 01895 614688
Fax: +44 01895 614882

Web: www.parexel.com

Considering Phase I studies in the UK?
……then PAREXEL’s Clinical Pharmacology Research Unit in London is your answer!

Located within the main building of Northwick Park Hospital, in London, the Unit has been in operation since 1991. The Unit has 36 dedicated study beds, with 2 additional beds for reserve subjects and special assessments. The Unit is one of five within PAREXEL, forming the PAREXEL Clinical Pharmacology Network. There are over 50 permanent staff, including a medical team of five, headed up by Dr John Lambert who has over 25 years clinical and research experience.

VAST EXPERIENCE
The Unit and its staff have many years’ experience in a wide range of healthy volunteer and patient studies including:

• ‘First in Man’
• Single, rising and multiple dose
• Biologics
• Pharmacokinetics
• Pharmacodynamics
• Bioavailability / Bioequivalance
• ‘Proof of Concept’
• Safety and tolerability
• Interaction studies

Additional services include:

• Drug Development and Regulatory Affairs Consulting
• Protocol design and review
• CRF design and review
• Data management
• Bioanalytical services
• PK / statistical analysis
• Medical writing

More than 250 studies have been conducted at the Unit, many of them ‘First in Man’, single dose and repeat dose studies covering various therapeutic areas. A wide range of pharmacodynamic methods and biomarkers are available.
In conjunction with Data Management, Programming and Statistical colleagues within the PAREXEL family the Unit is capable of delivering ‘headline results’ in days to assist planning and decision making in early clinical development.

Features of the 36-bed Unit include:

• 36 Clinical beds with cardiac monitoring
• 24 cardiac telemetry channels
• Dedicated laboratory and highly skilled technicians. Close co operation with Molecular Biology Laboratory run by Imperial College and situated adjacent to the PAREXEL Unit.
• Pharmacy with aseptic capability and a laminar flow cabinet (MHRA accredited)

UNIQUE LOCATION
The Unit is located within the main building of Northwick Park Hospital – a large National Health Service, University affiliated hospital. This allows the Unit the ability to work closely with the hospital’s consultants, to access laboratory, diagnostic (including MRI, CT and DEXA) and other services within the hospital.

Close links have been established with a number of Consultants and Departments in the hospital, and the following services have been provided for recent studies:

Exercise ECGs
Bronchoscopies
X rays
Ultrasounds
Nasal Endoscopies
Audiology
In addition, emergency services and specialist care is readily available.

PATIENT STUDIES
The PAREXEL staff are always happy to carry out feasibility assessments on any proposed Phase I or IIA study. There are very close links between the medical staff within the PAREXEL Unit and the staff at Northwick Park Hospital and surrounding GP surgeries and hospitals. 

VOLUNTEER CARE:
During studies, subjects enjoy comprehensive recreational facilities such as a pool table, comfortable television rooms, video games, Internet access and reading areas. Fresh calorie controlled meals are available and full housekeeping facilities are provided.

The large local population and proximity to the Capital makes attracting volunteers easy. With a London Underground station on-site, volunteers can reach the Unit from central London in less than 30 minutes. 

LOCAL KNOWLEDGE…WORLDWIDE CAPABILITY
As part of the PAREXEL Clinical Pharmacology International Network, PAREXEL’s Northwick Park Unit is able to benefit from considerable worldwide expertise and vast experience across multiple therapeutic areas.

Other benefits of PAREXEL’s global infrastructure include:

• World class facilities including two Bioanalytical Units (France and South Africa)
• Year-round studies of seasonally related disorders
• The ability to run large Phase II studies across all PAREXEL Units, to provide improved recruitment rates and standardisation of procedures.

5. Group Sector

• Clinical trials phase I/ IIa
• Special Expertise in Respiratory

6. Geographical Area

• United Kingdom
• Through our Clinical Pharmacology units in:- South Africa, United States of America, Germany and France.

7. Contact

• Dr John Lambert- Vice President of Clinical Pharmacology
• Chris Clare- Associate Director, Business Development