July 31, 2024
About Omar Consultants
Omar (Ophthalmic Medical and Research) Consulting Group is a North Carolina-based global medical consulting practice. Adept at unifying internal and external partners to expedite development, approval, and launch of breakthrough products in ophthalmology, hematology, metabolic diseases, and oncology; Omar Consultants are well-regarded and highly sought after individuals who are expert in strategic clinical development, medical and regulatory writing, translational research, and clinical trials. Omar consultants offer a long-standing record of achievement, career advancement, and continuous professional development.
The value we provide
- Meticulous creation of clinical development strategies for drugs, device, and biologics
- Collaborative management of device clinical evaluation documentation
- Thoughtful data analysis and reporting of clinical trial results
- Strategic preparation for meetings with regulatory agencies
Services
Omar Consulting Group was established to fill the gap between the bench and the bedside with product development support services for the pharma and medical industry.
Accomplishments
Woman Owned
Woman owned
Omar Consulting began as a combination of necessity and opportunity entrepreneurship in the ophthalmic space
In the period from 2007 to 2018 the proportion of woman-owned firms in the professional/scientific/ technical services category shrank from 14% to 12%
The 5 industries in which the numer of women-owned businesses grew the most between 2007 and 2018
151%
Utilities
126%
Other Services
94%
Construction
85%
Accommodation & Food Services
70%
Admin, Support,
Waste Mgt Services
Waste Mgt Services
Drug, Device, and Biologics Expertise
Drug, Device, and Biologics Expertise
In the period between 2007–2020 Omar Consultants has worked at the cutting edge of new entities and therapies to treat diseases with drugs, devices, and/or biologics
Drug, Device, and Biologics Clinical Development Experience
10
10
50
Preclinical
10
7
20
Phase 1
7
4
40
Phase 2
5
5
5
Phase 3
- Biologics
- Devices
- Drugs
Team Experience
Team Experience
More than 100 Clinical Studies designed since 2005
Fields:
- Ophthalmology
- Oncology
- Gastrointestinal
- Metabolic diseases
- Medical devices
Disease and therapeutic areas:
- Oncology 7%
- Metabolic and GI 10%
- Device 23%
- Ophthalmology 60%
Regulatory Agency Interactions
Regulatory Agency Interactions
FDA (Food and drug administration): Type A, Type B , and Type C meetings; medical device clinical reports
Health Canada (Government of Canada): Preclinical trial application (preCTA), scientific advice meetings, consultations
EMEA (European Medicines Agency): Consolidating ICH and FDA guidelines, medical device reports
Association Ocular Pharmacology and Therapeutics
XV Biennial Meeting (virtual)
March 4-7, 2021
Interests
Regulatory Agency
Interactions
Interactions
Board Service
Strategic Clinical
Development
Development
Clinical Trials
Women In
Ophthalmology
Ophthalmology
Advancement of Women
and Girls in Science
and Girls in Science
Recent Posts
March 19, 2024
Regulatory
Data information and disclosurePart 3 Author: Dr. Cheryl L. Rowe-Rendleman Some exciting new changes were announced in 2023 that affect both drugs and Biologics. In the United States, “biologics”... read more
November 30, 2023