Some of the services available to you ...

Biostatistics, Epidemiology and Research Design (BERD)

  • Statistical consultation
  • Statistical analysis of existing data
  • Grant development
  • Protocol development

Clinical Research Navigation

  • Central study registration
  • Feasibility consultation (subject population and personnel)
  • Protocol / Consent development
  • Regulatory Assistance
    • Investigational New Drug (IND) assistance
    • Investigational Device Exemption (IDE) assistance
    • Humanitarian Use Device Exemption (HDE) assistance
  • Clinicaltrials.gov registration
  • Budget negotiation
  • Contract negotiation
  • Data use agreements / Material transfer agreements
  • Affiliate agreements (ECMC, BGH, etc.)
  • Non-Disclosure Agreements (NDA) / Confidential Disclosure Agreements (CDA)
  • Coverage analysis review
  • Clinical Research Center (CRC) use
  • Study coordinator support
  • IRB submission guidance
    • IRB Click software assistance
  • General questions regarding Clinical Research Office (CRO), IRB, CTRC contacts and services
  • OnCore Clinical Trial Management System (CTMS) assistance

Community Engagement

  • Project Development
    • Consultation on research design, implementation, and/or dissemination
    • Mentorship on community-based or practice-based translational research
    • Review of grants, presentations, and/or manuscripts
  • Recruitment Assistance
    • Advisement on recruitment strategies/techniques
    • Recruitment trainings
      • Community considerations with the enrollment process
      • Obtaining informed consent
      • Community interaction/safety during recruitment
    • ResearchMatch (a free recruitment tool and feasibility analysis resource for researchers)
    • Recruitment of special populations
      • Children (under 18)
      • Elders (65 and older)
      • Underrepresented groups i.e. minorities, LGBT, rural, etc.
  • Integrating the Community into Your Research
    • Development of community advisement boards (CAB)
    • Connecting with community partners i.e. community based organization, health practice, church, etc.
    • Research trainings for community members
      • CITI human subjects
      • Basic research skill such as data collection, interviewing, etc.
    • Community feedback on research proposals/projects
    • Recruitment of special populations

Drug Development

Study Design

  • Drug discovery, medicinal chemistry, mechanism of action studies
  • Pre-clinical
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • Allometric scaling of preclinical pharmacokinetics/human dose projections
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • PBPK modeling for human dose projection for small molecule drugs 
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  •  PBPK modeling for prediction of non-linear disposition and for human dose projection for monoclonal antibodies
  • Genomics and tumor sequencing for actionable molecular aberrations
  • Clinical Trial Simulation
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • Phase I dose-finding 
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • Phase II
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • Phase III
    • Research integrity
    • NDA or IND enabling preclinical efficacy
  • Phase II/III drug interaction 
    • Research integrity
    • NDA or IND enabling preclinical efficacy

Laboratory

  • Small molecule screening core
    • Discovery 
  • Cytochrome P450 isoform/membrane transporter profile
    • Research integrity/discovery
    • cGLP
  • Formulations development
    • Nanomedicine formulation
    • Emulsions
    • Suspensions
    • Tablet/capsule
    • Research integrity
    • cGMP
  • Monoclonal antibody production, purification and development
    • Research integrity
    • cGMP
  • Production, purification, and characterization of monoclonal antibody and other protein therapeutics
    • Research integrity/discovery 
    • cGMP
  • cGMP production of immunotherapeutics (is one Roswell and one UB PHC – see above; combine with above)
    • Research integrity only
    • cGMP
  • Biophysical characterization of drugs and formulations (fluorescence, circular dichroism, IR, particle size, calorimetry)
    • Research integrity
    • cGMP
  • LC/MS/MS assay development and validation
    • Small molecules (< m.w.)
    • Large molecules (> m.w.)
    • In biological matrices
    • In formulations
    • In vitro solutions 
    • Research integrity only
    • cGLP (For preclinical or clinical)
    • CLIA/NYS DOH CLEP
  • ELISA development and validation for biotherapeutics
    • Large molecules (> m.w.)
    • Monoclonal antibodies
    • In biological matrices
    • In formulations
    • In vitro solutions 
    • Research integrity only
    • cGLP (For preclinical or clinical)
  • Proteomics and biomarker development
    • Research integrity only
    • cGLP (For preclinical or clinical)
  • Pathology
    • Research integrity only
    • CLIA/NYS DOH CLEP
  • Pharmacogenetics
    • Research integrity only
    • CLIA/NYS DOH CLEP

Data Analysis

  • Pharmacokinetics and pharmacodynamics modeling and statistics
    • Research integrity only
    • NDA or IND for FDA
  • PBPK modeling for human dose projection for small molecule drugs 
    • Research integrity only
    • NDA or IND for FDA
  • PBPK modeling for prediction of non-linear disposition and for human dose projection for monoclonal antibodies 
    • Research integrity only
    • NDA or IND for FDA
  • Population PK/PD modeling 
    • Research integrity only
    • NDA or IND for FDA
  • Target validation and systems pharmacology modeling
    • Research integrity only
    • NDA or IND for FDA

Research Support

  • Pharmacology sample procurement, processing, storage and shipping 
    • Research integrity only 
    • cGLP (For preclinical or clinical)
    • CLIA/NYS DOH CLEP
  •  Lab quality assurance assessments 
    • Research integrity only 
    • cGLP (For preclinical or clinical)
    • CLIA/NYS DOH CLEP
  •  Patient safety & pharmacovigilance 
    • Training

 

Advanced Imaging

  •  3T MRI
  •  9.4T MRI
  •  PET/CT

Laboratory Facilities

  • Genomics and Proteomics
  • Laboratory Animal Facilities
  • Biorepositories and Tissue Specimens
  • Immunology and Histology
  • Microscopy and Imaging
  • Drug Development and Pharmacology
  • Stem Cell Core Facilities