Your Biopharmaceutical Development and Manufacturing Partner

Clinical Development

Partners can expect a smooth transition into clinical development based on Nanotherapeutics’ experience.
Nanotherapeutics Clinical Development Team (NCDT), comprised of a cross-functional team of personnel representing Regulatory, Clinical, Quality, Nonclinical and Manufacturing, will manage and oversee the clinical program strategy. A clinical development plan is developed for each program early in product development. Nanotherapeutics will engage a CRO to identify clinical sites and to conduct the required clinical studies. Nanotherapeutics can also maintain responsibility to oversee and direct the program. The NCDT will assure open lines of communication between all stakeholders and maintain defined reporting structures. With our teaming partners, Nanotherapeutics has been successful with the enrollment of approximately 20,000 healthy volunteers supporting multiple programs for the DOD and the U.S. Department of Health and Human Services. Clinical study support includes:

  • Clinical Development Plan
  • Clinical protocol development
  • Investigator’s Brochure
  • Informed Consent Form
  • Clinical Monitoring Plan
  • Statistical Analysis Plan
  • Data Management Plan
  • Institutional Review Board Management
  • Clinical study implementation
  • Clinical study report

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