Research

Contract Research

Our investigators are skilled at testing natural medicine products, devices, and tests used in clinical practice and are passionate about building the evidence base for natural medicine. Specializing in clinical trials, our investigators are trained in all aspects of research design, including safety and tolerability (i.e., Phase 1 and 2 trials), efficacy (i.e., Phase 3 trials) and practice-based observational outcomes research and pragmatic trials. We understand there are unique challenges in natural products and integrative medicine research, and work within an environment ready to overcome those barriers through proportionate considerations of risk vs. potential benefits.

Contract services available include:

  • Subject matter consultation on natural products and integrative medicine research, including formulation, informal and formal literature reviews (as technical abstracts and systematic reviews)
  • Protocol development
  • Clinical research implementation and operational support
  • Consultation on Investigational New Drug requirements and preparation
  • Clinical/practice-based outcomes assessment
  • Statistical services
  • Database development
  • Central data coordination
  • IRB review

With a long track record of conducting successful complementary and integrative health research, and extensive experience in natural product research, we are prepared to offer a highly qualified and responsive research team, tailored to each project’s individual needs. Our specialized services are often available at a lower cost than other contract research organizations due to our low overheard rate for contract research and our ability to create streamlined investigator teams. The NUNM IRB is accustomed to working with complementary and integrative health interventions, including natural products, and thus we do not face many of the biases and challenges present in conventionally-oriented research environments – without compromising participant safety or undercutting regulatory requirements.

The following are examples of project processes and timelines. For additional information about contract research contact Dr. Joshua Goldenberg

IRB Review

Time frame: 1-3 months

  • IRB review is available for external organizations.
  • An IRB review fee is required for external research – research that is not submitted by an NUNM principal investigator.
  • To be an NUNM PI, an individual must be a current NUNM faculty member (covered by NUNM’s insurance) and affiliated with the Helfgott Research Institute.
  • Visit the IRB FAQ page and IRB Review Exemptions page for details on when IRB review is required.
  • For details on the submission process, visit the Scientific Review and IRB Submissions page.

Literature Review

Time frame: 2-6 months, depending on scope and topic

  • Comprehensive database search for current and past relevant research literature.
  • The final product is typically an annotated abstract or a literature review for publication in a journal or magazine.

Protocol Development

Time frame: 2-4 months

  • Study design including development of scientific background and rationale.
  • Selection of appropriate study outcome measures and controls.
  • Detailed experimental research protocol and associated documents required for IRB submission.
  • Study implementation budget.
  • Operational plan for implementation including data collection and analysis.
  • Assistance with IRB submission, responses to the IRB and finalizing approvals can also be included at this phase.

Pilot Study

Time frame: 9-18 months

  • Requires protocol development as described above or existing research protocol and associated documents.
  • IRB submission and review
  • Study intervention
  • Data collection
  • Data management
  • Project coordination
  • Data analysis

Clinical Trial

Time frame: Varies depending on sample size, duration and clinical characteristics of participants

  • Investigative team
  • Study design (minimum number of study participants to achieve statistical significance)
  • Protocol documents
  • IRB submission and review
  • Participant recruitment
  • Study implementation per protocol
  • Laboratory testing
  • Data collection
  • Data management
  • Data analysis (biostatistician)
  • Final manuscript for publication, upon mutual agreement