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Strategic Clinical Design and Regulatory Meetings

Target Product Profiles

The Target Product Profile (TPP) is the living document that is at the core of strategic clinical design:

A

Provides the scope of development for a therapeutic

B

Lists the known attributes of a clinical development plan and describes the gaps that must be filled before successful funding and/or launch of a product

C

Provides a format for discussions between a sponsor and the FDA that can be used throughout the drug development process

D

Describes the value and net worth of your development program to potential investors and stakeholders

The TPP embodies the notion of beginning with the goal in mind. Omar Consultants are experienced in development of TPPs

Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf

Protocol Validation

Omar Consulting and its CRO partners will help you validate your protocol. These services include:

Identifying barriers
Identifying barriers to patient recruitment
Qualifying sites
Qualifying sites
Remedies
Remedies for slow enrollment
Understanding competitive landscapes
endpoints analysis
Primary and Secondary endpoints analysis
Correct selection of PROs
Correct selection of PROs (patient reported outcomes)

Sometimes even a well-validated protocol must be amended. When this happens, Omar Consulting will help you amend your protocol and provide you with submission ready copies for your investigational review board.

ubpopulation Optimization

Subpopulation Optimization

Omar Consulting partners specialize in bridging studies and extrapolation of data to special subpopulations.

Omar Consulting helps clients with global studies to determine whether ethnic bridging studies may be necessary through adequate characterization of:

  • PK/PD
  • Efficacy and Safety
  • Dose-Response

Strategic Design Elements and Parallel Activities for Drugs and Biologics

Omar Consulting lends expertise to help develop strategic approaches to design of clinical programs
for drugs and biologics from preclinical research thru market launch.

strategic design strategic design

At the end of Phase 3 trials a New Drug Application (NDA) or, in the case of a biologic, a Biologics License Application is usually submitted to the regulatory agency, with a request for approval to market a specific compound for the indications specified in the application.

Source: Modern Methods of Clinical Investigation, Institute of Medicine (US) Committee on Technological Innovation in Medicine; Gelijns AC, editor

Strategic Stages of Device Development in US and EU

US: Class I and II Devices

us class devices us class devices

EU: Class I and II Devices

eu class devices eu class devices
The way in which devices are regulated in the US and EU is evolving. The US FDA has expanded the different classifications available available for novel and low risk devices. It has committed to faster clearances for 510K classifications. The EU requires more clinical data than the US for market approvals. Additional postmarket follow-up may be required for future applications of devices in certain risk classes.

FDA Meetings

There are four types of formal meetings that can occur between requesters and FDA staff:
Type A, Type B, Type B (end of phase (EOP), and Type C

fda meetings fda meetings

Omar Consultants will help you prepare for your next FDA meeting

Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf