Comprehensive Early Phase Clinical Trial CRO​

With close to two decades of experience conducting phase I clinical trials, our CRO team of scientific, medical, and clinical research coordinators have improved patient access to cutting edge immunotherapy clinical trials and earned industry trust. Our team is experienced in pioneering Investigational New Drugs (INDs), specializing in Immuno-Oncology and Cell & Gene Therapy clinical trials for solid tumors. Explore below some of our specific CRO capabilities. ​

Pre-Clinical and Clinical Development

  • Clinical development plan​
  • Trial-associated documentation​
  • Medical & scientific writing​
  • Budget & contract negotiation​
  • Pre-IND/IND consultations & submissions​
  • Translational analytical development and risk mitigation ​
  • Process and assay development​
  • Common Technical Document (CTD), including CMC, support

Regulatory Compliance

 

  • FDA, IRB, and IBC guidance and submission​
  • Regulatory GxP training (GLP, GMP, GDP, GCP) ​
  • Regulatory inspection preparation and mock audits​
  • Medical safety monitoring​
  • Accreditations, certifications, and standards guidance and oversight
  • IND Package Development​

Clinical Trial and Quality Management 

  • Clinical Study Oversight and Execution​
  • Project management​
  • Single-site and multi-site feasibility support​
  • Safety and Efficacy Reporting​
  • Study start-up communication​
  • Document control management​
  • Quality assurance and Quality control guidance and implementation​
  • Risk analysis and Corrective Action & Preventative Action (CAPA)

e-Clinical Data Solutions

 

  • Electronic Data Capture system (EDC)​
  • Possible add-ons:
    • eSource
    • eCRF
    • ePro
    • eReg,
    • eConsent
    • eCOA​
  • Data management and support​
  • Data quality, integrity and security oversight​
  • Bioinformatics ​
  • Health Informatics Technology (HIT) data consultation