Primary Endpoint Solutions was founded because, incredibly, the majority of Phase III clinical trials fail. History is littered with studies in which replication of results was not accomplished, where site variation was profound, and where expected efficacy signals were not obtained.

How can that happen when drugs have been vetted in two prior study phases, as well as in pre-clinical testing?

Perhaps the test agent simply doesn’t work. Or are there significant shortcomings in study design and, particularly, in the selection and capture of primary and secondary endpoints?

It is not surprising, given the wide variation in clinical practice standards, clinical raters’ experiences and training, and weak descriptions of specific endpoint criteria, that sponsors often find themselves dealing with endpoint data that are uninterpretable and inconsistent across sites and investigators. This can be especially true when endpoints are based on responses that are dependent on clinician rater assessments. PES was founded to focus solely on these problems and provide its client partners with the highest endpoint data quality.

PES is a Clinical Quality & Good Clinical Practice (GCP-compliant) service provider backed by a team of drug discovery professionals.

Clinical Expertise and Study Experience:

  • Evaluation of treatment of periodontal defects
  • Chemotherapy and radiation-induced mucositis
  • Dermatologic and gastrointestinal effects of treatment of NSCLC
  • Oral ulcerative mucositis in cancer patients
  • Treatment of oral dysesthesia
  • Genomic risk prediction of arthralgia in breast cancer patients
  • Acute oral mucositis and acute GVHD prevention
  • Oral mucositis in patients receiving somatotopic chemotherapy
  • Treatment of mucositis after stem cell transplantation
  • Gene-based targeting of oral mucositis treatments
  • Predicting oral mucositis response in stem cell transplant patients
  • Measuring the effectiveness of hydrogels for oral mucositis