PaediaCRO GmbH

PaediaCRO - your specialised CRO for your product development in paediatric use. Founded in 2007 by Prof. Dr. med., Dr. rer. nat., Dr. h. c. mult. Dieter Adam, Dr. rer. nat. Josef Hofer and Dipl.-Math. Jürgen Wyen, PaediaCRO will support you in the development of solutions for your products in paediatric use.

Our Vision is

A happy smile of a child is our vision.

Our Mission

To achieve this, PaediaCRO develops with its partners medicinal products to save children’s life and improve their quality.

We are convinced that

Ø R&D for new and well known treatment for children is needed to supply save and efficient treatment for children

Ø specific interdisciplinary cooperation between pharmacists, caring physicians, industry and CROs will achieve this challenging task.

Ø with our scientific approach, knowledge, creativity and experience PaediaCRO will develop solutions for your paediatric R&D programs.

PaediaCRO provides services for scientific advice, clinical research, data management, statistical analysis, medical writing and regulatory.

In clinical research we plan, perform and evaluate your paediatric clinical trials:

· development of paediatric study protocols

· identification and evaluation of qualified paediatric investigational sites

· monitoring and trial management

Services in data management and statistical analysis:

· sample size estimation

· data entry

· eCRFs

· query management and data consistency concepts

· statistical analysis

Regulatory Services are:

· Request for Scientific Advice for paediatric use related questions

· Preparation for Paediatric Investigation Plan (PIP)

· Request for PIP Agreement

· Request for authorisation of conduction of clinical trials

· Preparation and Submission of Request for PUMA

· Preparation and Submission of New Drug Applications