TCD MENA Company Profie

Company

Profile

COMPANY
PROFILE

CRO

Page No - 01 Company Profile

TABLE OF
CONTENT

About Company 03
Vision & Mission
Why TCD MENA? 04
Why Egypt?
Our Services 05
Our Partners 06
07
10

Company Profile Page No - 02

ABOUT
COMPANY

TCD MENA is a full-service Clinical

Research Organization (CRO) founded in
Egypt, 2016 and is licensed by the
Egyptian authorities.

We are specialized in the global
management of phase I-IV clinical trials
for biotechnology, pharmaceutical and
medical devices across most therapeutic
areas, besides assisting in the pre-mar-
keting development pathway for these
products.

We provide regulatory, clinical operations, data
management, biostatistics, pharmacovigilance,
and medical writing services to streamline the
execution of clinical trials and the development
of innovative treatments.

Page No - 03 Company Profile

Vision
& Mission

VISION POWERED BY COLLABORATION

Our vision is to be recognized as number one preferred CRO for pharmaceutical and
biotechnology sponsors for the management of clinical trials and the development of
innovative treatments worldwide. This will be achieved through a one-team approach,

over-performance, transparency, and professionalism.
TCD-MENA offers innovative guidance based on clients’ specific challenges, and supports

all phases of the clinical trial with a focus on achieving critical goals and timelines.
TCD-MENA exceeds expectations concerning ethics, laws and regulations.

MISSION FOR A POSITIVE EVOLUTION

TCD-MENA mission is committed to enhancing patients’ quality of life
while securing high quality clinical trial management services for our clients.

These come along with stepping up the development
of new, safe and effective therapies for the benefit of humanity.

Company Profile Page No - 04

Why
TCD MENA?

Client Focused

Trustworthy CRO focuses on client service, care, and satisfaction. Our
relationships with customers are based on trust, commitment, and
transparency.

Experienced Team

Highly skilled experienced team; including certified clinical research
professionals/associates.

Integrity & Regulatory Compliance

Integrity is at the core of our services through a fully honest, truthful, and
ethical conduct to our clients at all levels with regulatory compliance.

Reliability & Operational Excellence

Our services are reliable, professional, and proactive. We are a robust
company both technically and financially with operational excellence.

Quality & Cost Effectiveness

TCD MENA ensures that the services meet the highest standards of quality
nevertheless cost-effectiveness.

Page No - 05 Company Profile

Why
Egypt?

Egypt is the second-biggest destination country for clinical trials in
Africa. With a population of nearly 105 million, a high enrollment rate

is achieved in most of the studies.
Well-developed healthcare infrastructure through Hospitals

distributed all over the country.
Egypt has established a process of regulatory oversight of clinical
trials through the Egyptian Drug Authority (EDA) and the Ministry

Of Health (MOH).
Research Investigators with well-recognized expertise in clinical trials. 

Competitive and cost-effective budget.

Company Profile Page No - 06

OUR
Services

01 02

Product Development Plan Preclinical Research

TCD MENA provides a well-conceived and TCD MENA provides expertise in research and
comprehensive Product Development Plan that development necessary for navigating a drug
provides a detailed assessment of a new drug or a through animal testing and advancing into the clin-
medical device and the most effective pathway to ical phase. Preclinical research services involve
market, licensure, or clinical uptake. critical studies to asses drug efficacy and safety in
TCD MENA has expertise in providing qualified animal models and complete Investigational
input for the planning and execution of successful Product studies under the supervision of pharma-
strategies, allowing its clients to experience the ceutical scientists and experts following the ethics
benefits with significant value added to the and regulations set for animal use.
project.

03

Medical Device Development

TCD MENA possesses extensive experience in the
conduction of medical device trials, and is familiar
with their unique features and the challenges that
may arise putting into consideration regulatory
framework.
TCD MENA provides a full scope of medical device
clinical trials starting from protocol design in
adherence with ISO 14155, 13485 until submission
of clinical evaluation reports and technical files in
compliance with regulatory authorities’ regulations.

Page No - 07

Page No - 07 Company Profile

04 05

Clinical Research Medical Writing and Biostatistics

TCD MENA is dedicated providing clinical research TCD MENA provides fully integrated medical writing
solutions from feasibility and study start-up till solutions in all fields of clinical research and phar-
publication support. We provide a full range of maceutical development covering Literature review,
starting from first-In-Human Phase I trials to large Investigator’s brochure, Protocols, Informed con-
multicenter Phases II/III/IV trials, with a focus sent, Safety Updated Report, Clinical Study Report,
towards achieving faster time to market, reducing Clinical Evaluation Reports, Medical Publications
R&D costs, and increasing clinical trial success ...etc.
rates.
Our expert biostatisticians provide full biostatistical
TCD MENA Team has extensive clinical research support using up-to-date statistical methodolo-
experience in managing clinical trials; with strong gies. They apply scientific principles and therapeu-
relationships with KOLs across the country. The tic indication knowledge to support clients
team has worked in various therapeutic areas throughout the entire clinical development process.
including but not limited to: Oncology, Hepatology,
Internal Medicine, Infectious diseases, Gastroenter-
ology, Dentistry-Medical Devices, Endocrinology,
Cardiology.

TCD MENA also acts as a Functional Service Provider
for Pharmaceutical companies. We offer highly
qualified PM, CRAs and CRCs with flexible dedica-
tion and on a contract based adopted to clients’
specific needs.

Company Profile Page No - 08

06 07

Regulatory Affairs Medical Affairs

TCD MENA Regulatory affairs professionals, with TCD MENA provides clients with personalized,
their vast regulatory knowledge and experience on-the-ground abilities with field-based medical
provide clients with all the regulatory services they teams. Through this expertise, TCD MENA
need, either within the clinical trial scope or prod- supports clinical studies from the initial concept
uct registration through: considerations through protocol design and
development, protocol feasibility, medical moni-
Development and Preparation of CTD modules. toring, regional Key Opinion Leader (KOL) identifi-
Clinical expert review for CTD modules (Clinical & cation, up to regulatory submission.
Non-clinical).
Preparation and submission of documents as per
local regulatory requirements.
Submission of e-CTD via Extedo software or via
e-CTD office.
Product Information Preparation and Update
(SmPC, PIL, IB, labeling).
Preparation of scientific file for herbal medicines.
Design of the artwork to meet the requirements of
the regulatory authorities.
Post approval maintenance.

Page No - 09 Company Profile

08 09

GxP Audits and Training Courses
Bioequivalence centers audits
TCD MENA provides a wide range of professional
TCD MENA acts as a third party in conducting GxP courses to meet the needs of the clinical and
audits on service providers. pharmaceutical field professionals; GCP, GLP,
Biostatistics, Medical writing, Bioequivalence,
TCD MENA provides auditing services for accredited Regulatory affairs……etc.
local regional bioequivalence centers for their
bioequivalence (BE), and bioavailability (BA) studies
through its highly qualified and experienced moni-
tors to ensure the integrity of these studies are in
accordance with the regulatory requirements of
countries managing & requiring these bioequiva-
lence studies, and to ensure that these studies are
conducted as per specific standards like ICH, GCP,
FDA, EMEA.

OUR
Partners

Company Profile Page No - 10

Scan Here

Contact Us

: [email protected] / [email protected] : 01552882588 \ 01020401654
: 112 B ammar Ibn Yasser, Heliopolis, Egypt : www.tcd-mena.com : +20226249903