Paediatric Research Consultancy

Welcome to Paediatric Research Consultancy (PRC)

A cost efficient  service for your paediatric clinical trials

PRC is a cost efficient, ethical and  professional service to optimise paediatric clinical development by helping  you avoid expensive pitfalls commonly associated with testing medicines for children. 

Metrics of good recruitment, retention and time to market are vital aspects of good paediatric trial management in a difficult world economy. It is therefore critical to mitigate costly and easily avoidable delays. Planning child and family-friendly studies early and ethically optimises a  "win-win" for company and child.

PRC has  17 years experience  managing paediatric trials at site, 12 years writing information sheets for children & parents, 7 years as a Paediatric Research Consultant and 3 years as a member of the European Commission FP7 ethics panel. All work is performed to ICH/GCP and ethical best practice. Clients include global,  medium and SME pharmaceutical companies. biotech, universities and CROs.

PRC SERVICE OVERVIEW
Planning & feasibility advice for operational challenges
Specialist medical writing for children, parents and patients 
Ethical issues and help with FP7 grant applications
Paediatric investigator site assistance
In-company bespoke training and workshops 
PRC expert network for writing PIPs, PK advice and more
Benefits of using PRC
Ethos and ethics

Planning & feasibility advice for operational challenges
-   Paediatric protocol  feasibility for PRACTICAL and ETHICAL challenges
-   Paediatric investigation plan (PIP) feasibility and help at clock stop
-   Management advice to avoid common pitfalls
-   Consent and assent expertise and best practice
-   Recruitment and compliance strategies
-   Paediatric trial "rescue"

Specialist medical writing for children, parents and patients
-  Age appropriate, child, parent and ethics committee friendly information sheets
-  All-age (5-85) easy to understand patient recruitment material
-  Paediatric clinical trial communications copy e.g. disease & treatment information
-  Consent and assent forms
-  Medically accurate and child friendly artwork for young child verbal assent forms
-  Fertility/pregnancy test  information sheets for pubescent study girls
-  Easy language general medical information for patients and the lay public
-  Paediatric PIL information (under regulatory supervision)

Help with ethical issues, Ethics Committee and European Commission grant apllications
Where there is no conflict of interest, PRC can give you valuable assistance with:
-  Writing ethics sections of paediatric protocols to smooth ethics committee/IRB review
-  FP7, European Research Council and Marie Curie grant applications*
-  Paediatric protocol ethical feasibility for Paediatric Investigation Plans (PIPs)
-  "Mock" ethics committee review
-  UK ethics committee applications to identify and solve issues that slow down review process
-  Data Safety Monitoring Board ethics advice
*  Expert help is available regarding project specific issues but the ethical review process is confidential

Paediatric investigator site assistance
-  Help with preparation for paediatric trial GCP inspections
-  Co-monitoring assistance at site for companies
-  Training site staff e.g. recruitment, ethical issues, consent & assent
-  Research nurse help at site e.g. to cover holiday leave (UK only) 

 In-company bespoke training and workshops 
-  In house or at location to suit client
-  Presentations, workshops or lunchtime talks
-  Informative and enjoyable
- Tailored to suit client requirements
-  Cost effective as staff time and travel minimised
-  Please see "client comments" section for feedback

PRC expert network for writing PIPs, PK advice and more
-  Carefully chosen to match your needs
-  Writing Paediatric Investigation Plans
-  Legal and health economics expertise to maximise IP and ROI
-  Small batch paediatric formulation manufacture
-  PK/PD and scientific advice
-  Elegant microdosing/microsampling for ADME
-  Child friendly communications technologies
-  Small sample metabolite sampling
-  Small sample central laboratories
-  Needle free technologies

 Benefits of using PRC expertise
-  Saves you TIME and your company MONEY
-  Reduces number of centres used
-  Greatly improves ethics application outcomes
-  Gives added value to your trial
- Improves communications with parents and children
 - Optimises recruitment, retention & compliance
-  Improves time to market
-  Avoids expensive  pitfalls
-  Facilitates informed consent/assent
-  Prevents slippage of deadlines

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Social Media Jane Lamprill, owner of PRC is not on facebook or twitter EU Privacy and Electronic Communications Directive  This website does not plant cookies on your computer to track your internet usage or identify who/where you are. PRC tracking cookies ONLY identify if you are a first time or repeat visitor and how many pages you view. Please note that by clicking on this website you agree to this analysis. Further upgrades are in progress to ensure that you receive this message before you chose to land on this site Protecting your privacy If you have given me your business card it is assumed that you are happy for me to have your contact details PRC e-newsletters always contain an opt-out clause and are never sent to unknown recipients All client and enquirer contact details are kept securely on an encrypted and password protected hard drive No contact details are ever shared with third parties without prior express consent

Site updated  19 March  2013

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