Advarra aims to accelerate pediatric trials in an agreement

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Hero Images)
(Image: Getty/Hero Images)

Related tags: advarra, Pediatrics, Clinical trial, Clinical research, Clinical trial sites, Clinical trial site, Irb

Advarra will provide IRB services to the Institute for Advanced Clinical Trials for Children’s pediatric clinical trial site network.

The institutional review board (IRB) service provider will work with the Institute for Advanced Clinical Trials (I-ACT) for Children as it grows its trial site network, which currently includes 44 pediatric research sites in the US.

I-ACT for Children aims to accelerate biomedical innovation for child-centered clinical trial networks and stakeholders to accelerate site startup and completion of global pediatric studies. Pat Donnelly, CEO of Advarra told us that the network is focusing specifically on pediatrics to accelerate the establishment of safety and effectiveness data for approved and unapproved treatments.

Which Laura Gordon, CEO of I-ACT for Children, said in a statement that providing central IRB services as part of the site network is an imperative aspect of making pediatric trials more efficient.

He added that the network is continuing to add patients, investigators, and caregivers to provide independent guidance on developing the most respectful pediatric plans and protocols possible.

The US Food and Drug Administration (FDA) requires specific additional protections to be considered in pediatric trials, “this includes determining the specific level of risk presented, the prospect of direct benefit, and determining whether assent is necessary, and if so, how it’s documented,”​ said Donnelly.

Related news

Related products

show more

Stability Testing As a Quality Control Measure

Stability Testing As a Quality Control Measure

Frontage Laboratories | 19-Jun-2019 | Technical / White Paper

Stability testing is, in essence, a quality control process and is there¬fore a vital component of every phase of clinical development for both large and...

Import Risks & Clinical Supply Depots

Import Risks & Clinical Supply Depots

Catalent Pharma Solutions | 07-Nov-2018 | Case Study

A sponsor running a clinical trial in Israel arranged to ship their clinical trial product from Europe to a depot in Israel. With the protocol based in...

Discover Fermion’s new API unit 4 in Hanko

Discover Fermion’s new API unit 4 in Hanko

Recorded the 04-Sep-2018 | Webinar

Join this webinar to learn more about Fermion’s new manufacturing unit 4 at the Hanko site. This webinar will provide virtual tour to our new state of...

Related suppliers

Follow us

Products

View more

Webinars