Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Short biography
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  • Welcome to Paediatric Research Consultancy (PRC)

    A cost efficient  service for your paediatric clinical trials

    Paediatric Research Consultancy™ is passionate about enabling the ethical and smooth running of paediatric clinical trials. The picture shows a nurse listening to a girl's heart rate

    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.

    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
    -  C
    ost 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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    PRC Ethos and ethics
    Protect - Respect - Connect ©

    Economical rates charged in 5, not 15 minute blocks
    High quality and ethical services
    -  Respect for global-local research etiquette
    ICH/GCP and regulatory compliance
    -  Work performed to Good Ethical Practice (GEP) ©
    Up to date continuting professional development
    Balances need of company AND child
    Saves you time and your company money
    Flexible: Ad hoc contracts or retainer basis
    Independent honest, impartial advice
    -  Assurance of commercial confidentiality
    Integrity around conflict of interest
    Flexible and rapid response wherever possible
    -  Website and client privacy protection (see below)

    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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