Research Ethics

Ethics Readiness Service

Pre-requisites by PI for IRB Application

Background & Significance of Study

Research Question, Study Aims & Hypothesis

Outcomes, Selected Endpoints & Methods of Assessment

Sample Size Calculation/ Justification

Statistical Plan

Study Design And Rationale Of Design

Full List Of Study Procedures & Data Variables Collectible

Clearance Of Institutional Requirements

Supporting in Areas of Need for New Clinical
Research Application

UNDERSTANDING ENTREPRISE NEEDS
EVALUATION OF CERTIFICATION NECESSITIES
POC BETWEEN PI AND IRB

PRE CONSULTATION

PRE-FILLING OF FORM WITH PI
NHG ROAM (BIOMEDICAL)
NHG ROAM (POPULATION HEALTH)

IRB APPLICATION

CO-DRAFTING OF ICF WITH PI

INFORMED CONSENT FORM

CROSS CHECK PROTOCOL AND APPLICATION SUBMISSION
IE: IRB APPLICATION FORM, ICF, DATA COLLECTION FORM

STUDY PROTOCOL

AMENDMENTS TO EXISTING IRB FORM WHERE REQUIRED
AMENDMENTS TO STUDY PROTOCOL/ICF/DATA COLLECTION FORM

REVISION BASED ON NEW AMENDMENTS

ASSISTING WITH SUBMISSION OF STUDY STATUS REPORT FORM
IE: CURRENT STATUS OF STUDY, ON-GOING COMPLIANCE WITH REGULATIONS/ REPORTING OF RECRUITMENT NUMBERS

STUDY STATUS REPORT FORM

RESEARCH APPLICATION COMPLETE

COMPLETE

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 and IRB requirements will prolong IRB approval timeline
Manpower constraint – Effort needed to understand all requirements and to follow-up with IRB query and answer during the entire review process
Funding constraint – Long review and approval timeline will eat into grant approval period

What Sets Us Apart?

Strong Guidance

We hold your hand throughout the entire process. Equipped with real-world engineering and manufacturing knowledge specifically in the medical technology space, our team at Access-2-Healthcare provides in-depth, unerring consultation in design planning, design input and output, design transfer, organisation design reviews, integrating risk management processes, and design validation and verification.

We Go Straight to the Point

We can assist you in eliminating superfluous needless information while still giving you with sufficient specs. Our goal to help you keep documentation burden to an optimum – something very few would know. If necessary, we can assist in the completion of the complete technical file and in assisting you with commercialization efforts. We use all of these factors to enable us to think creatively and develop novel ways to assist you.