Research Development Office

The Research Development Office (RDO) is available to assist clinical investigators in all  HUMC departments and units with the conception, design, and implementation of novel clinical and basic research including Phase I-IV clinical trials, translational research studies, and outcomes research projects.  Our team works closely with investigators and researchers to coalesce their research plan into a well-designed, written research protocol and can provide expert guidance on federal and local regulatory requirements.  The RDOis also available to assist with the development of statistical analysis plans, advanced data analysis, and the preparation of presentations and manuscripts.

Please feel free to contact us any time if you:

  • Have an idea for a novel research project you wish to pursue
  • Need assistance with the design, conduct, or analysis of an existing research study
  • Require guidance, education, or training on any area of research

Clinical Research Development Section

Our Clinical Research Development staffcan provide guidance to investigators developing new research studies or assist investigators in the enhancement of ongoing clinical trials.

 Areas of expertise include: 

  • Study design including the development of study aims, hypotheses, methodologies, outcome measurements, and eligibility criteria
  • Regulatory compliance including sponsor requirements, IND submissions to the FDA, IRB approval, informed consent and HIPAA issues
  • Study execution including subject recruitment strategies, compliance with Good Clinical Practice (GCP), research coordinator training, creation of data capture tools and case report forms, questionnaire development, and data security

For more information, please contact:

Larry Lyons, MPH
Clinical Trials Advisor
The David and Alice Jurist Institute for Research
40 Prospect Avenue
Hackensack, NJ 07601
551-996-8125
llyons@HackensackUMC.org

Biostatistics Section

Our Biostatistics staff collaborates with the HUMC investigators on an array of projects including basic science, translational, clinical, epidemiological, observational and outcomes research studies.  The studies range from small, single center, pilot studies to larger multi-center clinical trials.  The Biostatistics staff consults with investigators on data analysis and provides statistical support.

Services provided include: 

  • Study design including sample size calculation, randomization schema, analysis plans and stopping rules
    • Data management
    • Statistical programming
    • Statistical analysis and interpretation
    • Statistical input into grant applications and manuscripts 

PUBLICATIONS AND ABSTRACTS

For information on biostatistical services, please contact:

Themba Nyirenda, PhD
Research Biostatistician
The David and Alice Jurist Institute for Research
40 Prospect Avenue
Hackensack, NJ 07601
551-996-8210
tnyirenda@HackensackUMC.org

RESOURCES:

RDO GUIDELINES

CURRENT RESEARCH ACTIVITIES

 
 


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