
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
...Professional Services in Clinical Research |
|
|
|
|
|
|
...Independent Clinical Research Management |
|
|
|
|
|
Dr Graeme Scott |
|
|
|
|
|
|
|
|
|
Useful Links
[I think they're useful. If you have
suggestions let me know]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Section 1 is useful bodies and
university courses.
Section 2 is CROs I have worked
with.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Section 1 - useful bodies and university courses
ABPI - Association of
British Pharmaceutical Industry
The organisation to which about 100 British pharmaceutical companies
belong.
Companies are generally represented at the ABPI by the
company’s Medical
Director. The ABPI have produced a number of
useful publications relevant to
clinical researchers. Site has links to
many pharma companies.
|
|
|
|
ACDM - Association of
Clinical Data Managers
ACDM comprises mainly industry-based Data Managers (developers and
managers
of clinical trial databases, not to be confused with Oncology data Managers).
ACDM jointly run a part-time post-graduate qualification in data management at
Kingston University.
GO TO TOP
|
|
|
|
The Institute of Clinical
Research
Since May 2000 this has been the name for what was the Association of Clinical
Research for the Pharmaceutical Industry. In my opinion, this is the
premier European body for all personnel engaged or associated with
clinical research. If you aren't a member, it's well worth joining.
Especially good value are the GCP and Ethics Forums that run
frequently in London and the Scottish Forum that runs in Stirling. Even better: they are free!
Scottish Forum meetings are October 2002 and then 3 times per year
from 2003..
|
|
|
|
AIOPI –
Association of Information Officers in the Pharmaceutical Industry
AIOPI represent those industry personnel providing medical
information to
pharmacists, doctors and others. Most drug companies
with licensed
products have a formal medical information service.
|
|
|
|
BARQA - British
Association of Research Quality Assurance
BARQA represent those in the industry involved in one or more
aspects of QA: GCP, GLP and GMP and has good links and
detailed
information.
GO TO TOP
|
|
|
|
BIRA
- British Association of Regulatory Affairs
Well informed site on all aspects of regulatory issues both UK
and world-wide.
|
|
|
|
EFGCP - European
Forum for Good Clinical Practice
Focuses on specific aspects of GCP through a range of special
interest working parties who provide expert opinions and position papers
on GCP topics.
|
|
|
|
ICH –
International Conference on Harmonisation
(of technical requirements for registration of
pharmaceuticals for human use)The process that brought together the regulatory authorities of
Europe, Japan and the United States and experts from the
pharmaceutical industry in the three regions to discuss scientific
and
technical aspects of product registration to streamline the
development process for new pharmaceuticals.
The web site contains all
you need to know about ICH and all the
latest updates on the status of
the process.
GO TO TOP
|
|
|
|
IFPMA
International Federation of Pharmaceutical Manufacturers Associations
Provides the secretariat for ICH and will take you to ICH
information sites.
|
|
|
|
MedDRA - Global Standard
Medical Terminology
Designed to supersede or
replace all other terminologies used within the medical product
development process, including COSTART, WHO-ART, J-ART, and HARTS.
Major global regulatory
authorities (FDA, EMEA, MHW) are adopting MedDRA and moving toward
requiring its use. The FDA has already implemented MedDRA within its
Adverse Event Reporting System (AERS). European authorities are
beginning to use MedDRA as a key component of their electronic
database systems. The MedDRA Maintenance and Support Services
Organization (MSSO) was established by the ICH to speed and facilitate
the adoption of MedDRA by both the regulatory and medical products
manufacturing communities. MSSO is also responsible for making sure
the terminology is updated regularly and that it remains responsive to
user needs.
|
|
|
|
SteoRN SteoRN
are a small network of experts (mainly based in Scotland) who operate
globally to provide a wide range of services to organisations in the
human healthcare sector. I am current chairman of the organisation
that comprises about 20 members, a mix of freelance and small
companies (up to 10 staff).
GO TO TOP
|
|
|
|
Liverpool
John Moores University – Clinical Research Courses
A group of us set up the first course for site personnel (CCR) in
1995. I developed the post-graduate programme in 1997. The CCR has an
annual intake of 45 and fees are about £700 for the one year course
(Sept 2000 next intake).
The post-grad programme offers Certificate, Diploma and MSc levels
and has had almost 200 students in the first two and a half years from Jan 1998.
Fees vary depending on the amount studied from about £700 for 1
module to £4250 for the full diploma course (Jan 2000). Course
leaders Alan George (LJMU) and Sue Fitzpatrick (ACRPI:ICR). Contact
ACRPI:ICR for details.
There are also courses at University
of Wales, Cardiff (Diploma in Clinical Science) and University of
Surrey (MSc in Pharmaceutical Medicine)
GO
TO TOP
|
|
|
|
Section 2: CROs I have worked with
Specialists:
GO TO TOP
Strategic product
development
Data Management
and Statistics
Independent Audit
Monitoring
Radiolabelled imaging
Full service/clinical
Strategic product development (back)
Pleiad Ltd
Small Scotland-based company with particular expertise in product
development planning and strategic product review. Specialise in advising
biotech companies and would-be investors. Directors: Helen Colquhoun, Julia
Edgar.
|
|
Data Management and Statistics(back)
Om-First Ltd
Specialist Data Management CRO and consultancy in M3/M4 area with Indian
arm to company for reduced costs. Access to all phases of clinical research
in India through Indian subsidiary. Director Paresh Patel.
|
|
Pharmapart
UK Ltd
Based at Stirling Innovation Park, this is a first rate group of
Statisticians with whom I collaborate. They also offer CRA services and Data Management in
this country and have a Swiss parent company, through which other services
are available. Director: Stephan Henauer.
|
|
Nottingham Clinical Research Ltd
(was Nottingham Clinical Trial Data Centre) Specialist data management and statistics CRO in East Midlands. Also
provides randomisation service.
Director Allan Skene. Tel 0115 969 1169
|
|
Statwood Ltd
Data Managers and Chartered Statisticians, providing superior consultancy on design and
analysis as well as data management and statistical analysis of clinical
trials. Managing Director: David Unerwood.
|
|
Anne Whitehead (e-mail
only)
Consultant statistician, providing advice on design and analysis.
|
|
Jill
Altman B.Sc. (e-mail only)
Jill Altman is a consultant statistician with
extensive experience of the application of statistical methods in the
design of clinical trials. |
|
Independent Audit(back)
Ashdown Clinical Research
(e-mail only)
Reliable independent GCP auditor (Clive Jenkins) with many years' highly
regarded experience. Based North Wales - covers the world. E-mail:
ashclin@mcmail.com.
Telephone 0468 352384 (mobile).
|
|
Good
Clinical Research Practices
Wendy Bohaychuk and Graham Ball have offices in
Canada and the UK and offer a world-wide audit service. My work with Wendy
has been limited to teaching on the Liverpool Clinical Research Courses,
but GCRP are widely respected for both auditing and training.
|
|
Monitoring(back)
CDSS Ltd
Small monitoring CRO based in Manchester with field staff. Also provide
contract-in staff in various disciplines and as of 2001 also provide
contract Site Co-ordinators. Director: John Illingworth.
|
|
Radiolabelled imaging(back)
Pharmaceutical Profiles
As of August 2000 this is the world's largest CRO specialising in
radiolabelled imaging studies. Based in East Midlands (UK). I have conducted
two studies with them, both of lung deposition of inhaled preparations.
|
|
Full service/clinical(back)
Quintiles
World's largest CRO as at July 2000 with around 15000 staff I believe.
Full service CRO. I have worked with Q Scotland (Clinical, Stats - now
dissolved, Data Management, Drug Packaging) and Q Battle (Stats and Data
Management).
|
|
Paragon Biomedical
American CRO with well distributed network of monitors across the USA
(some employed, some freelance). Based in Irvine, California, they also have
a Data Management and Statistics capability. Director Nick Reed.
|
|
Inveresk Research
Edinburgh CRO offering most, if not all aspects of drug development. They
have a consumer product testing unit for patch tests and the like and have
experience in large scale trials of OTC medicines.
|
|
PPD Development
(Chelmsford and Belgium offices)
PPD Development is a full service CRO with offices around the world. I
worked effectively with the Belgian office on one trial and the Chelmsford
Unit conducted a complex trial of a novel injector for one of my clients.
|
|
Kendle UK
Kendle were a largely US company until SMS was taken over by Kendle in
1999. Focus' Data Management arm was acquired a few weeks later. Provide
all clinical aspects in UK. Also provide contract site co-ordinators. Have
a team of experienced field-based monitors who have been with the company
(as SMS) for several years.
|
|
 |
|
|
|