Clients & Projects (GCP)

GCP Basics Android App (Europe) CHCUK android app

February 2012

CHCUK have published an Android app – GCP Basics (Europe), is a comprehensive app developed by CHCUK that guides you through the requirements for conducting clinical trials in Europe in accordance with the Clinical Trial Directive (2001/20/EC) and the GCP Directive (2005/28/EC).  The UK has been used as an example of how these European Directives have been implemented at the ‘Member State’ level.
GCP Basics ‘ includes a step-wise guide of GCP considerations from the history of GCP through to implementation, conduct, completion and archiving of clinical trials conducted in Europe.

GCP Basics iPhone App (Europe) iphone app

January 2012

CHCUK have published an iPhone App – GCP Basics (Europe), is a comprehensive app developed by CHCUK that guides you through the requirements for conducting clinical trials in Europe in accordance with the Clinical Trial Directive (2001/20/EC) and the GCP Directive (2005/28/EC).  The UK has been used as an example of how these European Directives have been implemented at the ‘Member State’ level.
GCP Basics‘ includes a step-wise guide of GCP considerations from the history of GCP through to implementation, conduct, completion and archiving of clinical trials conducted in Europe.

The GCP Basic app will be available for the Android market in the very near future.

Clinical Trials Act 2011 (Mauritius)Mauritius

August 2009 to May 2011

Drafted the Clinical Trials Bill (now Act) for the Republic of Mauritius. Provided expert GCP guidance and support throughout the process.

Deliverable: Clinical Trials Act 2011

GCP Consultants to the NIHR (UK) NIHR

March 2010 to Present

CHCUK provides expert GCP guidance and advise to the UK’s National Institute of Health Research (NIHR). This includes creating a GCP Resources documents (link provided), provision of ad hoc advice, drafting the GCP refresher training and provision of expert compliance support for the on-line GCP offering.

Testimonial: ” Stuart’s knowledge and expertise has played a critical role in the on-going development of both the taught  NIHR Introduction to GCP and GCP refresher courses.  The GCP resources that Stuart developed for us are  a tremendous help to the many researchers who access them regularly via our website.  His expert  knowledge of the clinical trials regulations and his passion to share best practice is one of the reasons we are fortunate to  have the opportunity to work with Stuart.” Paul Maher, GCP Training Manager, CRN Workforce Development, National Institute for Health Research Clinical Research Network (NIHR CRN) – October 10, 2011

Stuart’s knowledge and expertise has played a critical role in the on-going development of both the taught NIHR Introduction to GCP and GCP refresher courses. The GCP resources that Stuart developed for us are a tremendous help to the many researchers who access them regularly via our website. His expert knowledge of the clinical trials regulations and his passion to share best practice is one of the reasons we are fortunate to have the opportunity to work with Stuart.

Paul Maher, GCP Training Manager, CRN Workforce Development, National Institute for Health Research Clinical Research Network (NIHR CRN) – October 10, 2011

The London Clinic – Clinical Trial Support

December 2010 to June 2011

CHCUK recently provided clinical trial GCP compliance support to the London Clinic to support the creation and implementation of their new clinical research facility, ‘The Advanced Therapies Centre’.

Stuart has provided the advanced therapies centre with expert, up to date information on Clinical trials regulations and extensive group wide gap analysis. This invaluable help and flexibility assisted our quick start up for clinical trials at The London Clinic.

Alistair Gifford-Moore, Clinical Trials Manager, Advanced Therapies Centre at The London Clinic – August 31, 2011

Top qualities: Great Results, Expert, High Integrity

GCP Compliance Support

July 2009 to Present

CHCUK provides and has provided GCP compliance support to a number of organisations and companies. The support ranges from performing a GCP compliance gap analysis (Health check) on the existing systems and providing solutions and options to bridge gaps, where identified and/or improve the robustness of existing systems and processes; through to providing support in developing Research Governance Groups and Frameworks (NHS), developing SOPs, creating legal acts, training staff and acting as ad hoc consultants.

Clients include:

AllerganNHS_ScotlandCHDIGE_Healthcare

 

 

Allergan, CHDI Foundation, GE Healthcare, NIHR, NHS Trusts, Phlexglobal, Prism, Prn Services, Republic of Mauritius, The London Clinic

Creation of ‘GCP Considerations’ Publications

July 2009 to present

CHCUK have developed (and will continue to develop) a range of complimentary ‘GCP Considerations’ reports.  We believe that there is a minimum level of information that should be readily available to all clinical researchers which is why many of our tools and services are free to access.