Supporting the Littlest Ones

Supporting the Littlest Ones

At the forefront of pediatric drug development

We have performed, over our history:

  • 310+Clinical Studies
  • 25+Indications

Biotech and pharma companies today face increased regulatory requirements for pediatric trials as they address the need to advance treatments for diseases unique to children. Pediatric development plans are a requirement for new drugs in the US and EU, and pediatric clinical research is on the rise. Recruitment, ethical, scientific, logistical challenges, and product labeling all pose specific needs in studies aimed at children.

At Synteract, we understand pediatric development. Our recent acquisition of KinderPharm builds on Synteract’s extensive experience in navigating complex regulatory environments and commitment to pediatric drug development. With advanced pharmacometric modeling and clinical trial simulation technologies, juvenile formulation, and toxicology services across pediatric indications we offer both preclinical and clinical drug development services.

Our single source model services:

Why work with Synteract for pediatric clinical trials?

There are many reasons to work with Synteract. But there are 5 key reasons to work with Synteract for pediatric trials that are of particular importance.

In addition, we are at the forefront of working with sponsors in this space, having conducted 310+ pediatric clinical studies, globally. Our pediatric cross-functional team helps clients navigate the complexities of pediatric research and provides tailored pediatric development planning and experienced technical and operational services to allow medicines to reach patients in need, including medical and regulatory strategy, protocol development, trial design as well as submission, follow-up and updates of PSPs and PIPs.

“Pursuing our full commitment to pediatric development, we are now integrating Synteract’s existing base of experience and leadership with the focused knowledge and expertise that KinderPharm has provided its clients for many years. Together we become the leading CRO for pediatric services, delivering a single source model for preclinical and clinical development, along with the specialized operational and logistical understanding required in working with children and their families.”

Steve Powell, CEO Synteract

We understand the level of compassionate and specialized clinical and regulatory expertise required in working with vulnerable pediatric populations and their families. We collaborate with international pediatric networks, opinion leaders, patient advocacy groups, and regulatory bodies key to pediatric development and pediatric success, and capitalize on relationships with global partners invested in this patient population. Many of our executives are actively involved in the industry.

Contact us today to learn how our clinical experts can guide you through evolving global regulations and data requirements each step of the way.

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Synteract Pediatric Clinical Trial Leadership

Martin GrahamContact us to find out more about our Pediatric expertise and experience

Martin Graham
SVP, Pediatric Development and Scientific Innovation

Dr. Martin A Graham is a graduate of Leeds University, England where he earned his BSc in Pharmacology and Microbiology with Joint Honors in 1984. He went on to earn his PhD from the University of London at The Institute of Cancer Research, Royal Marsden Hospital, London UK in 1990. Dr. Graham conducted his post-doctoral research in anti-cancer drug development at the Beatson Institute at University of Glasgow before joining Sterling-Winthrop Pharmaceuticals, which later became Sanofi-Synthelabo, in both the UK and the US. Dr. Graham later served as Director of Pharmacokinetics at Centocor Corporation, a Johnson and Johnson Company; VP of Research and Development at Gemin X biotechnologies; and VP of Development and Regulatory Affairs at TetraLogic Pharmaceuticals.

Contact us to find out more about our Pediatric expertise and experience
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Synteract Pediatric Clinical Trial Leadership

Martine Dehlinger-KremerContact us to find out more about our Pediatric expertise and experience

Martine Dehlinger-Kremer
VP, Pediatric Development Europe

Contact us to find out more about our Pediatric expertise and experience
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Synteract Pediatric Clinical Trial Leadership

Lynne GeorgopoulosContact us to find out more about our Pediatric expertise and experience

Lynne Georgopoulos
VP, Pediatric Development Americas

Lynne Georgopoulos is an innovative, results-oriented, entrepreneurial-spirited biopharmaceutical executive with 25 years of experience in clinical operations/development, regulatory affairs, project management, and quality assurance. Lynne is a strong contributor to the leadership and team building of KinderPharm. Lynne manages the Clinical and Regulatory departments of KinderPharm as well as cross-functional groups, both internally and externally to meet aggressive development timelines. Lynne received a Master of Science in Health Sciences (MSHS) in Regulatory Affairs from The George Washington University and is regulatory affairs certified through the Regulatory Affairs Professional Society.

Contact us to find out more about our Pediatric expertise and experience
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