FREN

Paediatrics

Expertise tailored to paediatric clinical studies

Paediatric clinical research plays an essential role in developing safe and effective treatments for infants, children and adolescents. These studies require a specific approach that takes into account the regulatory, ethical and operational requirements unique to paediatric populations. Pharmaspecific supports sponsors, biotechs and medical device manufacturers in conducting their projects with expertise combining clinical operations, quality and regulatory affairs. This paediatric clinical research expertise addresses the specific challenges of studies involving paediatric populations.

Our teams work closely with sponsors, investigator sites, paediatric patients and their families to ensure studies run smoothly while safeguarding the safety, well-being and rights of participants.

recherche clinique en pédiatrie

THE CHALLENGES OF PAEDIATRIC CLINICAL STUDIES

Paediatric clinical research presents specific challenges related to participant recruitment, parental consent, adapting protocols to different age groups and the need to minimise the burden on children and their families as far as possible.

The success of these projects depends on rigorous coordination between sponsors, investigator sites and families, as well as particular attention to the patient experience and compliance with the ethical requirements applicable to paediatric research.

OUR PAEDIATRIC EXPERTISE

Pharmaspecific supports clinical studies involving paediatric populations by providing operational, regulatory and organisational support adapted to the specifics of these projects. Our teams make participation easier for children and their families while ensuring that studies comply with regulatory and ethical requirements. This paediatric clinical research expertise allows each project to be adapted to the specific needs of young participants.

With our expertise in clinical operations management and patient solutions, we help improve the participant experience and support study recruitment and retention goals.

OUR SERVICES FOR PAEDIATRIC STUDIES

Clinical project management

Management and coordination of activities to ensure studies run smoothly.

Clinical trial monitoring

Investigator site monitoring and verification of the quality of the data collected.

On-site coordination (CRC)

Operational support for investigator sites and research teams.

Regulatory affairs

Management of regulatory submissions and interactions with competent authorities.

GCP compliance audits

Assessment of study compliance with Good Clinical Practice.

Patient expense management

Handling and reimbursement of expenses incurred by participants.

Patient concierge support

Arrangement of travel, accommodation and services for participants.

EU legal representative

Regulatory support for sponsors based outside the European Union.
Recherche clinique

CONCRETE ACHIEVEMENTS IN CLINICAL RESEARCH

Every project presents specific scientific, regulatory and operational challenges. Drawing on its experience with sponsors, biotechs, medical device manufacturers and investigator sites, Pharmaspecific helps implement solutions tailored to the challenges of each study.

Discover through our case studies how our teams have contributed to the success of clinical projects across various therapeutic areas.

Let's talk about your project

Looking for an experienced CRO partner to support your paediatric clinical study?