Services
the first of an era
Primera ushers in a new era for G.I. research and development. We have identified two factors that add an enormous expense to clinical trials. The first is a delay in site initiation and activation and the second is subject randomization. Our team’s expertise and leadership position in the G.I. community has created our unique clinical network. Additionally, we offer teaching strategies that will aid investigators and their staff in the identification and retention of subjects.
We are diverse in all areas of gastrointestinal ailments. Our experience on the research side has led to the development and FDA approval of medications that treat GERD, IBS, IBD (including both Crohn’s and UC ), EOE, iron deficiency anemia, CIC, and OIC. Additionally, we have sponsored our own research investigating new indications of existing medications in the management of esophageal and gastric motility disorders.
Site acquisition
Rapid site initiation and development
Project management and study design
Data management
Database design
Data entry invalidation
Data and analysis
Laboratory and pathology
Site management
Case Monitoring
Regulatory and source documentation
Good clinical practice measures and certification
Audit and FDA inspection support
Compliance of sponsor and federal regulations
Laboratory and Personnel inspection
our areas of expertise
Gastrointestinal infections
Non-erosive reflux disease
Esophageal motility disorders
Gastric motility disorders
Helicobacter pylori
Peptic ulcer disease
Exocrine pancreatic insufficiency
Ulcerative colitis
Small intestinal bacterial overgrowth
Colon cancer screening
Celiac disease
Hepatobiliary diseases
Malabsorption syndromes
Crohn’s disease
Eosinophilic esophagitis
Gastroesophageal reflux disease
Device technology
Nutrition
Drug delivery
why primera?
Please note our company is flexible and can provide any or all of the above services according to the sponsors need as well as negotiate other requirements.