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Arkans - Clinical Research Organization

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Welcome To Arkans - Clinical Research Organization

Pediatrics

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.

Expertise

Arkans 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, Arkans 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

  • Arkans 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.

  • Arkans 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.

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