Over the years ADAMAS had assisted clients in a number of paediatric projects covering various therapeutic areas.  These have included studies related to treatment of infections in neonates, prevention of bleeding during surgery, treatment of ADHD and a vaccine study, to name but a few.  The investigator sites have been located in Europe, the United States and South East Asia.  Dr Mandy Hall Dryden, ADAMAS’ subject matter expert on paediatric studies, recently ran a training session for all our Consultants as a refresher and information sharing session.

It is estimated that between 60% and 80% of medicines used for children have not been evaluated formally.  Children differ anatomically and physiologically; they are not just ‘small adults’.  The route of administration and dosage form are important considerations, for instance acceptable tablet size is related to the age of the patient, as are dosing volumes for those drugs administered orally.  The relevant guideline on pharmaceutical development of medicines for paediatric use is EMA/CHMP/QWP/180157/2011 and there are a host of other relevant regulations and guidelines.  The EU paediatric regulation 1901/2006 & 1902/2006 defines its overall policy objective as to improve the health of the children of Europe by increasing the research, development and authorisation of medicinal products for use in children.  This overall objective is supported by a number of general objectives including one which aims to ensure that medicines used to treat children are subject to high quality research and appropriately authorised.  All the objectives listed in the regulation should be achieved ‘without subjecting children to unnecessary clinical trials and in full compliance with the EU Clinical Trials Directive’.  The paediatric population represents a vulnerable sub-group and special measures are needed to protect their rights.  Areas to be considered are composition of, or advice received by, the ethics committee, consent/assent, minimising risk and distress, and adverse event reporting.

Audits of paediatric studies are particularly important to ensure that the above areas are fully complied with in the interests of the patients, but also to ensure ethical and scientific integrity.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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