Welcome to Paediatric Research Consultancy (PRC)
Advice and help planning your paediatric clinical trials
From 26 July 2008, Paediatric Regulation EU/1901/2006 mandated that a compliance checked Paediatric Investigation Plan PIP) must be submitted with a drug company's European Marketing Authorisation Application or it will be rejected and the adult or child medicine will fail the licensing process. From 26 January 2009 the same will apply for line extensions.
PRC is an independent, ethical, flexible and cost effective service to help you avoid expensive pitfalls commonly associated with testing medicines for children. Metrics of good recruitment, retention and time to market are important aspects of paediatric trial management in a tight economy, so it is important to avoid costly delays.
PRC's 17 years of pharmaceutical and academic paediatric trial and 5 years consultancy experience can assist you with the practical, ethical, informed consent/assent, training, planning and operational aspects of your paediatric research. Clients include big and small pharmaceutical companies, biotech, CROs and Government agencies in Europe.
SERVICE OVERVIEW:
PRC services are split into 4 main areas:
Advice, Writing, Training, Expert network
PRC services are split into 4 main areas:
Advice, Writing, Training, Expert network
- ADVICE
- Paediatric investigation plans
- Practical and ethical protocol feasibility
- Ongoing ethical monitoring during trial
- Practical paediatric trial planning
- Consent/assent strategy
- Recruitment and compliance in different age groups
- Fertility issues/pregnancy test sensitivities
- Paediatric trial rescue
- WRITING
- Age specific information sheets by children's author
- Consent/assent forms
- Fertility information sheets
- Jargon free information for parents (and adult trials)
- UK paediatric trial ethics information sheets
- Artwork for very young children by children's artist
- Articles about paediatric clinical trials
- Easy to understand PIL leaflets (under supervision)
- TRAINING
- In house or at location to suit client
- Anywhere in non Eastern Europe
- Presentations, workshops or lunchtime talks
- Informative and enjoyable
- Tailored to suit client requirements
- Cost effective as staff travel minimised
- PRC EXPERT NETWORK
- Carefully chosen to match your needs
- Writing Paediatric Investigation Plans
- Small batch paediatric formulation manufacture
- PK/PD and scientific advice
- Child friendly communications technologies
- Small sample metabolite sampling
- Small sample central laboratories
- Needle free technologies
- Legal and IP services
- Healthcare communications
- Paediatric health economics
BENEFITS OF USING PRC EXPERTISE:
- Saves you TIME and your company MONEY
- Reduces number of centres used
- Gives added value to your trial
- Optimises recruitment, retention
- Improves time to market
- Avoids practical pitfalls
- Facilitates informed consent/assent
- Improves recruitment/ compliance
- Improves communications
- Reduces risk of ethics rejection
- Prevents costly delays
- Prevents slippage of deadlines
- First class service
- Economical rates
- High quality and ethical
- Balances need of company AND child
- Saves you time and your company money
- Flexible: Ad hoc contracts or retainer basis.
- Independent impartial advice
- ICH/GCP and regulatory compliance
- Global outlook for multicentre trials with
- Respect for local & cultural research etiquette
- Assurance of commercial confidentiality
- Integrity around conflict of interest
- Flexible and rapid response wherever possible
- Ongoing professional development a high priority
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Site updated 10 December 2008