...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.                                                                  

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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.

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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).

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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)

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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.