clinical operations

Aisa Pharma is a privately held, clinical-stage biopharmaceutical development company dedicated to bringing new disease-modifying treatments to patients with rare serious diseases. It focuses on repurposing and optimizing select calcium channel blockers, and its lead program is developing AISA-021, an oral therapy targeting N-type calcium channels for Raynaud's phenomenon associated with systemic sclerosis (scleroderma). The company is headquartered in Boston, Massachusetts, with additional presence in Sydney, Australia.

clinical developmentCMCdrug developmentRegulatory Affairsrepurposing and optimizing calcium channel blockers

Arroyo Research, Inc. (ARI) provides quality customized Phase I-Phase-IV clinical trial services, connecting sponsors with experienced, prescreened investigators and sites, and offering site feasibility and patient recruitment tools.

biostatisticsclinical monitoringconsultingdata managementInvestigator Selectionmedical devicesproject managementquality assuranceRegulatory Affairstechnology

Axella Research is a full-service clinical research organization for emerging biopharma, device and diagnostic companies. It combines FDA regulatory strategy, biostatistics, a community-based physician network and technology-integrated trial operations, with deep experience in oncology and urology. The company offers fee-for-service or shared-risk partnerships, and its operations run on Ecosera, an open clinical research platform.

biostatisticsdata managementfeasibility assessmentIND preparation and submissionmedical writingmonitoringpre-IND meetingsproject managementregulatory strategysite start-upSMO servicesstatistical programming

Bracane Company, Inc. is an award-winning consultancy founded in 2002 that advances research, compliance, and strategic program management across healthcare, public, and private sectors. It partners with public and private organizations to design, staff, and manage programs, with capabilities spanning clinical operations, quality audits, regulatory compliance, training, and workforce development.

operational supportprofessional placementsProgram Managementproject managementquality auditsregulatory compliancetraining and workforce development

BRCR Global is a clinical research organization founded in 2009 and headquartered in Weston, FL. It connects sites, investigators, patients, and sponsors through a clinical research platform supporting Phase I to Phase IV clinical trial implementation across the Americas and Caribbean, with a site network including locations in Puerto Rico (Mayagüez, San Juan, Ponce, Yauco).

clinical trial implementationdata operationsGCP-compliant study executiononcology researchpatient recruitmentregulatory supportstudy start-up

CRMG is a privately held, full-service consulting and contract research organization (CRO) based in Agawam, MA, founded in 1997 by Stephen Cincotta. It provides biotech and pharmaceutical companies with clinical development services supporting studies from Phases I–IV, with deep therapeutic focus in diabetes and metabolic/endocrine diseases, renal, oncology, hematology, analgesics, and gastroenterology.

clinical monitoringclinical supply logisticsfunctional service provider (FSP) offeringsMedical affairssafety servicesstrategic consultingstudy design guidancetrial master file (TMF) support