Pediatrics

Tailored solutions to bring treatments to patients faster

TFS HealthScience Pediatrics offers full-service support to biotech and pharmaceutical companies from early phase through phase III clinical development, post-approval authorization, and real-world evidence studies across all therapeutic areas.

Our experience has led to strong working relationships with clinical centers, site networks, key opinion leaders (KOLs), and patient advocacy groups. This means that we have a solid understanding of the specific challenges pediatric trials face and have implemented strategies to mitigate risks such as recruitment and retention, data accuracy, regulatory hurdles, and investigator training. We become your study partner delivering on-time, within budget, and with maximum quality.

TFS Pediatrics Offers

  • Patient Access

    Access to patients through our long-established relationships with therapeutically-specialized key opinion leaders (KOLs), clinical centers, site networks, and patient advocacy groups

  • Bespoke and flexible operational approach

    Tailored solutions from a variety of disciplines—project management, regulatory affairs, study start-up, clinical monitoring, data management, medical writing, and more—all dedicated to your program and working together seamlessly to provide best-in-class support for the study

  • Site Selection

    Sites selected for their motivated and expert investigators with proven clinical trial experience in the indication and support staff able to handle the requirements of the study

  • Monitoring models to fit the needs of pediatric research

    Close monitoring using a variety of models and methods, and project tracking to ensure quality data collection from the start

  • Global reach and local expertise

    Studies conducted to all global and country-specific regulatory standards and guidelines for pediatric research

Overcoming Pediatric Research Challenges

Clinical trials involving children are more challenging than adult studies including:

  • Physiological considerations - Assessments must take in account their smaller frames, organs, and body systems
  • Comprehension - Young children may not understand detailed instructions or they may still be too immature to cooperate consistently by staying still when asked, for example
  • Consent/Assent - Most studies require consent from the parents or legal guardian and in many countries both parents are required, even if the parents are separated

Depending on the trial and the ages of the children involved, TFS provides enhanced, age appropriate information for potential pediatric subjects.
Pediatric research usually involves the whole family. Therefore, we make the trial process as easy and stress-free as possible for children and their families to participate.

Understanding parental consent and assent

TFS has deep expertise managing the logistical requirements of global pediatric clinical trials including those presented by obtaining parental consent—often required on a rolling basis throughout the clinical trial. Each time the parent and child return to the clinic, confirmation of participation is required.

The age in which assent is required varies, but generally, children of six years of age and over are expected to provide some sort of consent. For children older than 15, there is the possibility that the child can provide their own consent, if they meet certain criteria.

TFS provides age appropriate materials to facilitate the consent/assent process. Similarly, we provided an enhanced level of information for parents, written in a family-friendly style. Our aim is to augment the both the standard assent and parental/patient consent process. Our experience is that children and parents are more likely to give assent/consent if they really understand the aims of the study and fully appreciate what will be involved.

To support the assent process in older children, we have found presenting the study information in different formats to work well, such as a comic format for young teenagers or a magazine format for older teenagers. Children completing clinic visits can be given a small, inexpensive gifts, such as a music download, or study mug complete with any associated study branding, if local regulations allow.

Case Study: Phase IIIb Trial in Adolescent Patients with Plaque Psoriasis

This study had all the challlenges of a pediatric trial plus required TFS to navigate a highly competitive treatment landscape with significant numbers of ongoing psoriasis studies, a high dropout rate due to placebo and GI symptoms, and certain drug characteristics (slow onset of action, gastrointestinal symptoms, flushing) and monitoring rules that required explanation to physicians and patients.

Study Phase: IIIb
Indication: Plaque psoriasis
Number of Patients: 130
Sites: 20
Services: Full Service

Read about the challenges and TFS solution

TFS Pediatric Studies
- Nearly 80 Studies in Last 5 Years

  • Oncology - 20%
  • Metabolic Disorders - 17%
  • Dermatology - 15%
  • Nutritional Disorders - 15%
  • Hematological Disorders - 11%
  • Central Nervous System - 9%
  • Infectious Diseases - 5%
  • Ophthalmology - 5%
  • Cardiovascural - 4%
  • Musculoskeletal - 3%
  • Gastrointestinal - 3%
  • Ear, Nose, and Throat Disorders - 2%
  • Women’s Health - 2%
  • Immunology & Hormonal Disorders - 1%
  • Genito-Urinary System - 1%
  • Other Diseases - 5%

One project, one team

TFS Pediatrics created a business unit to enhance and augment the already strong experience and expertise in this area. With our dedicated pediatrics project managers and physicians, we then craft a team from TFS therapeutic and functional groups that has the experience you need, when and where you need it.

  • Alison Sampson, PhD

    Head of Pediatrics, rare diseases, and orphan drugs

    • Oversees pediatric, rare, and orphan product development, actively working with centers of excellence, patient groups, and registries to promote study awareness and to implement tailored recruitment strategies
    • Specific rare diseases expertise in infants and children including studies in rare genetic, lysosomal storage disorders (Gaucher type III, Pompes and Tay-Sachs disease and Niemann-Pick C), growth hormone disorders, Dravet Syndrome and soft tissue sarcoma, etc
    • Direct experience working in corporate clinical development settings from study monitor and project leader to unit manager and head of business development
    • More than 20 years’ experience in clinical development working at large and mid-size CROs and pharmaceutical companies
    • Chartered Scientist Status via the Institute of Clinical Research and the Royal Society of Chemistry. Became a Fellow of the Royal Society of Chemistry in 2013

Tailored solutions to bring treatments to patients faster

We are ready to partner with you on your pediatrics clinical program. Whichever service we provide, we’re on your team.