FOCUS ON HYPOTHALAMO PITUITARY DISORDERS
Accelsiors prides itself with being among the leaders in Hypothalamo Pituitary Disorders (HPD). We are indeed masters in:
- Growth Hormone Disorders both in pediatric and adult population (GHD);
- Cushing syndrome, and
- GnRH agonists and antagonists.
Over the course of years, Accelsiors has conducted over 30 studies from Phase I (first in human) to Phase III registration trials. We have been or are involved in over 80% of all long acting rhGH development programs.
We have an established and trusted relationship with key recruiting sites globally – this extends to key opinion leaders on a global scale.
Considering the extreme screening failure rates in these indications, Accelsiors medical monitors have assessed and interpreted thousands of laboratory and clinical results in different Hypothalamo-pituitary Disorders, both in pediatric and adult populations, hence we know all the pitfalls in the diagnosis both in pediatric and adult patients.
We understand the status of competitive recruitment, the main success drivers and biggest drawbacks for patient recruitment.
By knowing the possible issues in the diagnosis and management of the HPDs, in both pediatric and adult patients, and by being in close contact with investigators, to guide them and give advice on how to decrease the screening failure rates, we ensure the best screening and effective ways of patient recruitment in this often challenging therapeutic area.
Accelsiors has significantly contributed to marketing authorization of several products aimed to treat HPDs, but also to very successful outlicensing of ongoing development programs.
We are offering the following services:
- We will help you understand all the pitfalls in the diagnosis of HPD both in adult and pediatric populations
- We will help you in designing studies that are feasible from both a clinical and ethical point of view
- We will help you in proper scheduling of assessments from the screening to study end in order to minimize the burden of the tests
- We will help you recognize false positive results in dynamic endocrinology testing
- We will help you in selecting of high recruiting sites with proven quality records in all HPD indications, irrespective of whether pediatric or adult study
- We will advise you on how to design in a less cumbersome way the blood samplings for the pediatric patients
- We will make sure that the pre-analytical blood handling, especially in complex PK/PD studies, is planned and addherred to preserve the analytes. We know how to ship most safely these samples to the central lab even from the most remote places
- We will ensure provision of highly accurate and reproducible data irrespective of study phase, involved population, or investigational site location
- We will help you design CRFs that are capturing really meaningful data
- We will provide you with statisticians that are experts in the field, with long standing experience