Therapeutic Areas

Pediatric Clinical Trials and Regulatory Expertise

Partner with the experts in pediatric clinical development success

Advancing therapies intended to treat pediatric patient populations is highly challenging, and complex. There are numerous con-founding challenges for treating children, including that many are rare or ultra/rare diseases, many are genetic diseases, and many can be life-threatening. With this, trial design and conduct come with heightened scrutiny for regulatory, ethical, and safety standards for children as patients. Finding and treating an adequate patient population requires a highly tailored approach to feasibility, patient recruitment, and site management strategies combined with the use of decentralized or virtual solutions.

Developing a therapy, biologic, or vaccine for use in children? Let's Talk.

60%

of global operations team members have experience supporting pediatric clinical development.

The need to get it right the first time is even more critical when dealing with diseases that affect children. Many of these are rare and ultra-rare diseases, with very limited patient populations and no other available treatment options.

Trust our integrated teams to support your pediatric trial with:

Strategic advice from scientific experts across all disciplines to support the planning of your pediatric clinical development program
Operational support to advance your clinical trial to its next milestone by finding and treating the right patients

The regulatory roadmap for clinical trials for therapies to treat children requires extra consideration and regulatory oversight.

Ensure regulatory success with regulatory consulting advice, marketing application support, and regulatory publishing.  

Additionally, if your therapies are intended to treat adult populations, our global regulatory experts can support preparing, writing, and submitting your initial Pediatric Study Plans (iPSPs) and/or Paediatric Investigation Plans (PIPs).

65%

of global regulatory experts have experience with pediatric therapies

Global Pediatric Full-Service Phase I/II Clinical Trial Begins on Heels of Successful Natural History Study

A mid-sized biotech company sought Veristat early in development for help with a Natural History trial. After its successful implementation, the sponsor moved forward with the gene therapy treatment program, which has already treated its first patients.

Read how Veristat continues to provide full-service support for this Phase 1/2 clinical trial.