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


Drug delivery

why primera?

Proven methodology in subject identification and retention
Geographical diversity of sites (most important in diseases that have genetic or immunological implications)
Long history of personal relationships/ friendships with a national consortium of fellow investigators

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.

innovation moves fast. so do we.