Assistance to Principal Investigators

Research Ethics Readiness Support

Current Challenges in Research Ethics Application

Lack of clarity

  • When is an Institutional Review Board (IRB) review and approval needed?

Lack of understanding of ethics application

  • Unfamiliarity with IRB requirements or application process
  • Unfamiliarity with ethics principles and research regulations that may apply

Resource constraints

  • Time constraint - Lack of understanding prolongs IRB approval timeline
  • Personnel constraints – Effort needed to understand to follow-up with IRB queries successfully
  • Funding constraints – Time and Personnel constraints impact grant approvals

We provide expertise and resource relief to Principal Investigators and Research Organisations by supporting the drafting and follow up of Institutional Review Board (IRB) applications until approval, therefore saving the PIs’ valuable time and enabling innovations to be deployed for clinical studies more efficiently.

This range of services is currently only available in Singapore.  Every country has a different procedure for IRB applications.

Pre-Application Guidance and Support

The first step we support Principal Investigators is to gather pertinent information Needed for an Institutional Review Board (IRB) Application on behalf of the PIs

Background information on proposed project

Study objectives(s)/ research question(s), current gaps/ limitations (related to the current standard of care)

Proposed clinical outcome measures/ endpoints

Details of the intervention/ proposed solution

Product brochure, instructions for use/ approved indication(s), how the solution will be used in the upcoming study, etc

Detailed study procedures

Experimental procedures, standard of care procedures, potential risks

Proposed study design

Type of study (pilot/ feasibility study/ randomized control trial/ pragmatic trial, etc)

Study population type and sample size required to test the solution

Inclusion and exclusion criteria, sample size calculation/ justification

Statistical analysis plan for collated study data

Study conduct operational details

Informed consent process, data collection and storage process, etc

Unsure if the study design meets requirements? Or unable to provide study design?

Access-2-Healthcare have in-house clinical specialists that can provide study design drafting if the endpoints and procedures are provided

Support in New Clinical Research Applications

We are supporting the PIs every step of the way

  • Understanding enterprise needs
  • Evaluation of certification necessities
  • Point of contact (POC) between Principal Investigator (PI) and Institutional Review Board (IRB)
  • Pre-Filling of form with Principal Investigator (PI)
  • Co-Drafting of Informed Consent Form (ICF) with Principal Investigator (PI)
  • Cross-check protocol and application submission
  • IE: Institutional Review Board (IRB) application form, Informed Consent Form (ICF) , data collection form

Support in Ongoing Research

  • Amendments to existing Institutional Review Board (IRB) form where required
  • Amendments to study protocol/ICF/data collection form
  • Assistance with the submission of the current status of study, on-going compliance with regulations/ reporting of recruitment numbers

What Set Us Apart?

Provide necessary relief from onerous paperwork
spend more time with patients or your innovation!
Manage tough questions
from the IRB until approval
Extend beyond ethics approvals
and supporting sponsors with study design support