www.nagyresearch.com
NagyResearch-MEACRO is a leading multi-country CRO in the MENA region, with
over 14 years of experience in Data Management and 5 years of experience in
Clinical Monitoring and Clinical Trial Management.
NagyResearch-MEACRO acquired vast knowledge of the local clinical
regulatory bodies and the procedures for rapid submission and approval.
We have immense experience of the local day-to-day life and different
cultures in MENA regions.
Your trials will run smoothly and without any setbacks
Kasr El Ainy street is one of
Cairo’s busiest streets. The
Egyptian
Ministry
of
Health is located about
100meters away from
here. It is home of Egypt’s
Central Ethical Committee
Protocol Design
and CRF Design
Data
Management up
to Database Lock
Biostatistics,
Analysis and
Medical Writing
Site Selection
Study
Submission
Monitoring
Site Initiation
and Patient
Recruitment
You do not have to worry about
coordinating between different
service providers.
Our Investigator Database
Our Site Selection SOP
Our CRAs are trained, experienced and very well versed with latest GCP and ICH
regulations.
No. of Clinical Trials by Country (2006-2009)
No. of Clinical Trials by Year (2006-2009)
16
14
20
12
10
15
8
6
4
10
5
2
0
0
2006
2007
2008
Currently running 27 clinical trials in different MENA regions
2009
Our Clinical Monitoring Department
Clinical Monitoring Manager
Lead
CRA /
Egypt
7 Fulltime
CRAs
4 Parttime
CRAs
Lead CRA / Gulf & LEVANT
1 Fulltime
CRA /
UAE
1 Full –
time
CRA /
Jordan
1 Parttime
CRA /
Lebanon
Lead CRA / North Africa
1 Fulltime
CRA /
KSA
2 Fulltime
CRAs /
Tunisia
1 Parttime
CRA /
Algeria
1 Fulltime
CRA /
Morocco
How do we handle our clinical trial data?
Our Data Management team is using the most
advanced clinical data management software
available and according to the highest regulatory
standards to ensure auditable GCP quality
results.
Our Data Management Services include:
•CRF Design
•Database Design
•Validation Rules
•Double Data Entry
•Electronic Data Capture (EDC)
•Handling External Data (Import/Export)
•Query Management
•Dictionary Services (MedDRA & WHODD)
•Quality Control
•Serious Adverse Event Reporting
•Database Lock
•Statistical Analysis
Our Data Management Infrastructure
For Clinical trial data we use US-based
validated GxP Data Centers.
For internal company intranet and
communication we use our own
dedicated servers maintained by
GoDaddy.
•Study and protocol management, design and tracking
vtrial™
is: and longitudinal studies)
(epidemiology
•Site status tracking
•Patient/CRF tracking, entry, and verification
•web-based
clinical
trialvisits
management
•Site initiation visits,
close-out
and audits software
•Able
provide
comprehensive
functionalities
•Flexibleto
data
entry including
double data entry
•Automated
double
datafriendly
entry comparison and
•Flexible and
user
synchronization
•Electronic and manual discrepancy identification and
automated data queries (ADQ) generation
•Paper
andautomates
electronic CRFand
management
vtrial™
streamlines workflow
•Serious Adverse Event (SAE) collection, processing,
processes
and increases the visibility of related
reconciliation and reporting
tasks
in a clinical
study.
•Robustand
querydata
management
capabilities
•Automated edit checks and validation for compliances
•Integrated medical coding references (MedDRA, WHO-Drug
or Sponsor-developed)
vTrialTM was in-house developed. It is actively maintained and updated by one of our data
management strategic partners.
We can provide Electronic Data Capture facilities for the investigators on-site.
 4 years of experience with eCRF
 Our vTrial-CTMS is full capable of
capturing, processing and storing data
 We keep daily backups
Our Disaster recovery plan is tested
every four months
The way others do it!
The way we do it!
Safety
Security
Storage facility in Abou Rawash, Egypt
Confidentiality
Boxes are
temporarily stored
in facility
Documents and picked up
Scanning, Indexing and
Quality Assurance
Our Record
Management Work
Flow
Documents are then:
Destroyed
Stored at Record
Center
Returned to Customer
Images are then:
Stored on digital
media
Uploaded to FTP site
Stored in archive
Our statistical analysis
solutions can be tailored per
project’s specific
requirements.
In addition to our in-house
Biostatistics team, we have
strong alliances with multiple
Biostatistics and Analysis
service providers.
Our Statistical Services include:
•Study design, sample sizing, randomization and protocol writing/review
•Data entry and data management (including tracking, validation checks & QC)
•SAS programming and table, figure and listing production for study reports
•Pharmacokinetic / Pharmacodynamic modeling
•Regulatory submission support (including ISS and ISE data integration & analysis)
•Statistical consultancy and DSMB statistical support
Since 1996, we have partnered with multi-national Pharma for over 200
medical writing and publication projects.
Our past projects span many therapeutic areas including:
•Antibiotics
•Autoimmune
•Oncology
•Cardiology
•Diabetes
•Neurology
•Anti-thrombosis
•Dermatitis
•Pediatrics
•Asthma
•Osteoporosis
We are happy to respond to your inquiries and quotation requests.
For a free consultation on your project, please contact us:
Dr. Magda Shafik
Clinical Research Manager
+20 12 3189 427
magda.shafik@nagyresearch.com
Mahmoud Ibrahim
Clinical Research Associate
+20 17 4436 648
mahmoud.ibrahim@nagyresearch.com