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 easy and stress-free for children and their families to participate.
Understanding parental consent and assent
TFS has deep expertise in 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 as well as an enhanced level of information for parents, written in a family-friendly style. Our aim is to augment both the standard assent and parental/patient consent process. We experience that children and parents are more likely to give assent/consent if they understand the study’s aims 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 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 challenges 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
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.
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.