Service Requests

Some of the services available to you ...

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

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

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